Trial Outcomes & Findings for Using the Cholinergic Anti-Inflammatory Pathway to Treat Systemic Lupus Musculoskeletal Pain (NCT NCT02822989)
NCT ID: NCT02822989
Last Updated: 2026-07-08
Results Overview
Patients rate their musculoskeletal pain by making a mark on a 10cm anchored Visual Analog Scale where 0=no musculoskeletal pain and 10 =worst possible musculoskeletal pain.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
5 days
Results posted on
2026-07-08
Participant Flow
Subjects were recruited from local clinics, word of mouth or from the ClinicalTrials.gov site.
No subjects were excluded from the study before assignment to a treatment group.
Participant milestones
| Measure |
Vagus Nerve Stimulation
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
6
|
|
Overall Study
COMPLETED
|
12
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Vagus Nerve Stimulation
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
Overall Study
Subject didn't complete 4 required stimulations secondary to a URI during influenza season.
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1
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0
|
Baseline Characteristics
Using the Cholinergic Anti-Inflammatory Pathway to Treat Systemic Lupus Musculoskeletal Pain
Baseline characteristics by cohort
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.7 years
STANDARD_DEVIATION 11.7 • n=9 Participants
|
54.2 years
STANDARD_DEVIATION 15.3 • n=27 Participants
|
48.5 years
STANDARD_DEVIATION 12.9 • n=267 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
18 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
7 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
10 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
18 Participants
n=267 Participants
|
|
Pain
|
6.7 cm
STANDARD_DEVIATION 1.0 • n=9 Participants
|
5.6 cm
STANDARD_DEVIATION 1.5 • n=27 Participants
|
6.3 cm
STANDARD_DEVIATION 1.2 • n=267 Participants
|
|
Fatigue
|
23.0 units on a scale
STANDARD_DEVIATION 9.1 • n=9 Participants
|
15.8 units on a scale
STANDARD_DEVIATION 5.4 • n=27 Participants
|
20.6 units on a scale
STANDARD_DEVIATION 7.9 • n=267 Participants
|
|
Tender joints
|
7 Tender joints per subject
STANDARD_DEVIATION 8.7 • n=9 Participants
|
13.3 Tender joints per subject
STANDARD_DEVIATION 8.9 • n=27 Participants
|
9.1 Tender joints per subject
STANDARD_DEVIATION 8.8 • n=267 Participants
|
|
Swollen joints
|
2 Swollen joints per subject
STANDARD_DEVIATION 2.2 • n=9 Participants
|
4.8 Swollen joints per subject
STANDARD_DEVIATION 4.1 • n=27 Participants
|
2.9 Swollen joints per subject
STANDARD_DEVIATION 2.8 • n=267 Participants
|
PRIMARY outcome
Timeframe: 5 daysPatients rate their musculoskeletal pain by making a mark on a 10cm anchored Visual Analog Scale where 0=no musculoskeletal pain and 10 =worst possible musculoskeletal pain.
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
Change in Musculoskeletal Pain From Baseline.
|
-5.00 units on a scale
Interval -5.8 to -3.1
|
0.10 units on a scale
Interval -10.0 to 1.0
|
PRIMARY outcome
Timeframe: 12 daysThe percentage of participants with grade 2 or higher treatment emergent adverse events will be assessed using the NCI-CTAEversion4.
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=13 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
Percentage of Subjects With Treatment Emergent Adverse Events.
|
1 Participants
|
0.00 Participants
|
SECONDARY outcome
Timeframe: 12 daysPatients rate their musculoskeletal pain by making a mark on a 10cm anchored Visual Analog Scale where 0=no musculoskeletal pain and 10 =worst possible musculoskeletal pain.
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
Change in Musculoskeletal Pain From Baseline
|
-5.35 units on a scale
Interval -5.8 to -1.45
|
.15 units on a scale
Interval -0.6 to 0.7
|
SECONDARY outcome
Timeframe: 5 daysChange from baseline fatigue will be measured using the FACIT F (Functional Assessment of Chronic Illness Therapy) questionnaire. The score ranges from 0 to 52, a higher score indicates less fatigue.
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
Fatigue
|
11.00 units on a scale
Interval 4.5 to 16.0
|
0.00 units on a scale
Interval -2.0 to 1.0
|
SECONDARY outcome
Timeframe: 12 daysChange from baseline fatigue will be measured using the FACIT F (Functional Assessment of Chronic Illness Therapy) questionnaire. The score ranges from 0 to 52, a higher score indicates less fatigue.
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
Fatigue
|
12.00 units on a scale
Interval 5.5 to 18.25
|
-2.00 units on a scale
Interval -3.0 to 1.0
|
SECONDARY outcome
Timeframe: 5 daysThe percentage of tender joints reduced from baseline assessed by an investigator upon examining 68 potential tender joints.
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
Tender Joint Reduction
|
100.0 percentage of tender joints
Interval 100.0 to 100.0
|
5.3 percentage of tender joints
Interval -11.1 to 80.0
|
SECONDARY outcome
Timeframe: 12 daysThe percentage of tender joints reduced from baseline assessed by an investigator upon examining 68 potential tender joints.
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
Tender Joint Reduction
|
98.5 percentage of tender joints
Interval 50.0 to 100.0
|
10.0 percentage of tender joints
Interval 0.0 to 34.6
|
SECONDARY outcome
Timeframe: 5 daysThe percentage of swollen joints reduced from baseline assessed by an investigator upon examining 66 potential swollen joints. Data shown for seven taVNS and five SS subjects with swollen joints at baseline.
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=7 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=5 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
Swollen Joint Count Reduction
|
100.0 percentage of swollen joints reduced
Interval 100.0 to 100.0
|
9.09 percentage of swollen joints reduced
Interval -8.33 to 57.15
|
SECONDARY outcome
Timeframe: 12 daysThe percentage of swollen joints reduced from baseline assessed by an investigator upon examining 66 potential swollen joints. Data shown for seven taVNS and five SS subjects with swollen joints at baseline.
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=7 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=5 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
Swollen Joint Count Reduction
|
100.0 percentage of swollen joints reduced
Interval 80.0 to 100.0
|
14.29 percentage of swollen joints reduced
Interval -100.0 to 59.09
|
SECONDARY outcome
Timeframe: 5 daysChange in PGA from baseline, an anchored visual analog scale.ranging from 0 to 3 with higher scores signifying higher disease activity.
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
Physician Global Assessment of Disease Activity (PGA)
|
-0.51 units on a scale (0-3)
Interval -0.99 to -0.3
|
0.04 units on a scale (0-3)
Interval -0.06 to 0.12
|
SECONDARY outcome
Timeframe: 12 daysChange in PGA from baseline, an anchored visual analog scale.ranging from 0 to 3 with higher scores signifying higher disease activity.
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
Physician Global Assessment of Disease Activity (PGA)
|
-0.50 units on a scale (0-3)
Interval -0.84 to -0.08
|
0.03 units on a scale (0-3)
Interval 0.03 to 0.12
|
SECONDARY outcome
Timeframe: 5 daysChange in Patient Global Assessment of disease (PtGA) from baseline. This measure is a 10 cm visual analog scale (0-10); higher scores indicate a higher patient assessment of their disease activity.
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
Patient Global Assessment of Disease (PtGA)
|
-22.50 units on a scale (mm)
Interval -46.5 to -2.5
|
4.00 units on a scale (mm)
Interval -2.0 to 9.0
|
SECONDARY outcome
Timeframe: 12 daysPopulation: -(-to -) -(-to )
Change in Patient Global Assessment of disease (PtGA) from baseline. This measure is a 10 cm visual analog scale (0-10); higher scores indicate a higher patient assessment of their disease activity.
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
Patient Global Assessment of Disease (PtGA)
|
-18.50 units on a scale (mm)
Interval -64.0 to -2.0
|
-0.52 units on a scale (mm)
Interval -16.0 to 9.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 daysPopulation: 0.00(0.00,) (-,-0.00)
Change from baseline of CRP levels in patient serum.
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
CRP
|
0.00 mg/dL
Interval -0.2 to 0.0
|
0.05 mg/dL
Interval -0.1 to 0.15
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 daysPopulation: 0.00(- ,0.00) (-,
Change from baseline of CRP levels in patient serum.
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
CRP
|
0.00 mg/dL
Interval -0.2 to 0.0
|
-0.05 mg/dL
Interval -0.23 to 0.08
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 daysChange from baseline of IFNα levels an inflammatory cytokine in patient serum.
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
IFNα
|
0.0 pg/ml
Interval 0.0 to 0.0
|
0.12 pg/ml
Interval -0.12 to 1.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 daysChange from baseline of IFNα levels an inflammatory cytokine in patient serum.
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
IFNα
|
0.00 pg/ml
Interval -0.01 to 0.0
|
0.25 pg/ml
Interval 0.0 to 1.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 daysChange from baseline of Il-6 levels in patient sera
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
Il-6
|
-0.39 pg/ml
Interval -2.89 to -0.03
|
0.17 pg/ml
Interval -3.35 to 2.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 daysChange from baseline of Il-6 levels in patient sera.
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
Il-6
|
-0.17 pg/ml
Interval -3.13 to 0.67
|
-0.20 pg/ml
Interval -3.35 to 0.25
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 daysChange from baseline of levels of IL-1β, an inflammatory cytokine in patient serum.
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
IL-1β
|
-0.01 pg/ml
Interval -0.4 to 0.2
|
-0.01 pg/ml
Interval -0.02 to 0.02
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 daysChange from baseline of levels of IL-1β, an inflammatory cytokine in patient serum.
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
IL-1β
|
-0.01 pg/ml
Interval -0.04 to 0.0
|
-0.04 pg/ml
Interval -0.05 to 0.04
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 daysChange from baseline of TNF levels, an inflammatory cytokine in patient serum.
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
TNF
|
-0.05 pg/ml
Interval -0.25 to 0.12
|
0.00 pg/ml
Interval -0.8 to 0.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 daysChange from baseline of TNF levels, an inflammatory cytokine in patient serum.
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
TNF
|
-0.05 pg/ml
Interval -0.25 to 0.12
|
-0.05 pg/ml
Interval -0.2 to 0.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 daysChange from baseline of IL-10 levels in patient serum.
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
IL-10
|
0.05 pg/ml
Interval -0.1 to 1.1
|
-0.08 pg/ml
Interval -0.16 to 0.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 daysChange from baseline of IL-10 levels in patient serum.
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
IL-10
|
0.12 pg/ml
Interval -0.17 to 0.23
|
0.04 pg/ml
Interval -0.1 to 0.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 daysChange from baseline of Il-1 RA levels in patient sera.
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
IL1-RA
|
-0.06 pg/ml
Interval -1.73 to 0.66
|
2.92 pg/ml
Interval -2.63 to 10.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 daysChange from baseline of Il-1 RA levels in patient sera.
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
IL-1 RA
|
0.41 pg/ml
Interval -10.68 to 1.73
|
-0.39 pg/ml
Interval -2.73 to 2.73
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 daysChange from baseline of Il-18 levels in patient sera.
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
Il-18
|
0.71 pg/ml
Interval -0.23 to 8.2
|
-0.21 pg/ml
Interval -2.47 to 0.92
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 daysChange from baseline of Il-18 levels in patient sera.
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
Il-18
|
-0.55 pg/ml
Interval -2.98 to 0.48
|
0.10 pg/ml
Interval -9.37 to 1.21
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 daysChange from baseline of serum levels of IL-8
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
IL-8
|
-0.21 pg/ml
Interval -2.25 to -0.01
|
0.77 pg/ml
Interval -1.1 to 1.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 daysPopulation: -(-to ) -(-to )
Change from baseline of serum levels of IL-8
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
IL-8
|
-0.17 pg/ml
Interval -2.54 to 0.45
|
-0.20 pg/ml
Interval -2.8 to 0.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 daysChange from baseline of plasma levels of substance P.
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
Substance P
|
-2.76 pg/ml
Interval -4.79 to 0.94
|
0.09 pg/ml
Interval -5.57 to 4.48
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 daysChange from baseline of plasma levels of substance P.
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
Substance P
|
4.90 pg/ml
Interval -2.41 to 8.23
|
5.08 pg/ml
Interval 0.24 to 9.98
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 daysChange from baseline of plasma levels of Neuropeptide Y.
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
Neuropeptide Y
|
0.30 pg/ml
Interval -6.05 to 5.2
|
2.0 pg/ml
Interval -1.38 to 14.98
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 daysChange from baseline of plasma levels of Neuropeptide Y.
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
Neuropeptide Y
|
-0.80 pg/ml
Interval -7.43 to 2.28
|
-2.25 pg/ml
Interval -4.38 to 5.48
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 daysChange from baseline of plasma levels of CGRP.
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
Calcitonin Gene-Related Peptide (CGRP)
|
0.00 pg/ml
Interval -2.0 to 4.7
|
0.00 pg/ml
Interval -1.98 to 2.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 daysChange from baseline of plasma levels of CGRP.
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
Calcitonin Gene-Related Peptide (CGRP)
|
-0.70 pg/ml
Interval -17.15 to 0.83
|
0.00 pg/ml
Interval -1.68 to 0.99
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 daysChange from baseline of serum levels of kynurenine
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
Kynurenine
|
-0.02 µM
Interval -0.35 to 0.18
|
0.155 µM
Interval -0.06 to 0.51
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 daysChange from baseline of serum levels of kynurenine
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
Kynurenine
|
-0.17 µM
Interval -0.56 to 0.18
|
0.27 µM
Interval 0.01 to 0.65
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 daysChange from baseline of serum levels of quinolinic acid
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
Quinolinic Acid
|
-51.0 nM
Interval -99.5 to -14.75
|
-35 nM
Interval -173.5 to 28.75
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 daysChange from baseline of serum levels of quinolinic acid
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
Quinolinic Acid
|
-100.0 nM
Interval -138.0 to -41.75
|
-12.5 nM
Interval -74.75 to 62.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 daysChange from baseline of serum Kynurenine/Tryptophan
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
Kynurenine/Tryptophan
|
0.001 µM/µM
Interval -0.004 to 0.005
|
-0.002 µM/µM
Interval -0.011 to 0.01
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 daysPopulation: -(-to ) (-to )
Change from baseline of serum Kynurenine/Tryptophan
Outcome measures
| Measure |
Vagus Nerve Stimulation
n=12 Participants
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 Participants
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
Kynurenine/Tryptophan
|
-0.003 µM/µM
Interval -0.007 to 0.008
|
0.001 µM/µM
Interval -0.004 to 0.008
|
Adverse Events
Vagus Nerve Stimulation
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sham Vagus Nerve Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vagus Nerve Stimulation
n=13 participants at risk
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
|
Sham Vagus Nerve Stimulation
n=6 participants at risk
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
7.7%
1/13 • Number of events 1 • 12 days
All adverse events with a severity greater than grade 1 are reported. The definition of an adverse event and/or serious adverse event used to collect adverse event information does not differ from that of clinicaltrials.gov. Other than the adverse event reported in the tables, no other adverse events were collected or reported.
|
0.00%
0/6 • 12 days
All adverse events with a severity greater than grade 1 are reported. The definition of an adverse event and/or serious adverse event used to collect adverse event information does not differ from that of clinicaltrials.gov. Other than the adverse event reported in the tables, no other adverse events were collected or reported.
|
Additional Information
Cynthia Aranow M.D.
Feinstein Institute for Medical Research
Phone: 516 562-3845
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place