Trial Outcomes & Findings for Transcutaneous Vagus Nerve Stimulation for the Treatment of Lupus (NCT NCT02917265)
NCT ID: NCT02917265
Last Updated: 2020-03-03
Results Overview
Achieving a BICLA response requires to meet all of the following parameters: 1. All British Isles Lupus Assessment Group (BILAG) A scores improving to B/C/D and all BILAG level B scores improving to C/D 2. No single new BILAG A \& not \>1 new BILAG B scores, no worsening of the baseline Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score AND no worsening in the Physician Global Assessment (PGA) (\<10% worsening from baseline) 3. No initiation of non-protocol treatments or premature study discontinuation The range of values for the above instruments are listed below, with higher scores indicating more active disease: BILAG: 0 to 96 SLEDAI: 0 to 105 PGA: 0-3
TERMINATED
PHASE2
7 participants
12 weeks
2020-03-03
Participant Flow
Participants were recruited at the Rheumatology Research Clinic of the Oklahoma Medical Research Foundation between 9.2015 and 5.2017.
Screening and randomization occurred at the same visit. One individual failed screening due to severe depression.
Participant milestones
| Measure |
TENS for Vagus Stimulation
A transcutaneous electrical nerve stimulation (TENS) unit is applied to tragus, the area of the external ear innervated by the auricular branch of the vagus nerve.
TENS for vagus stimulation: TENS electrodes are applied the tragus of the external ear.
|
TENS for Sham Stimulation
A TENS unit is applied to the earlobe, an area of the external ear that is devoid of vagus innervation.
TENS for sham stimulation: TENS electrodes are applied on the earlobe.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
2
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
TENS for Vagus Stimulation
A transcutaneous electrical nerve stimulation (TENS) unit is applied to tragus, the area of the external ear innervated by the auricular branch of the vagus nerve.
TENS for vagus stimulation: TENS electrodes are applied the tragus of the external ear.
|
TENS for Sham Stimulation
A TENS unit is applied to the earlobe, an area of the external ear that is devoid of vagus innervation.
TENS for sham stimulation: TENS electrodes are applied on the earlobe.
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Transcutaneous Vagus Nerve Stimulation for the Treatment of Lupus
Baseline characteristics by cohort
| Measure |
TENS for Vagus Stimulation
n=5 Participants
A transcutaneous electrical nerve stimulation (TENS) unit is applied to an area of the external ear that is innervated by the auricular branch of the vagus nerve.
TENS for vagus stimulation: TENS electrodes are applied on an area of the external ear innervated by the auricular branch of the vagus nerve.
|
TENS for Sham Stimulation
n=2 Participants
A TENS unit is applied to an area of the external ear that is devoid of vagus innervation.
TENS for sham stimulation: TENS electrodes are applied on an area of the external ear devoid of vagus innervation.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Continuous
|
50 years
n=99 Participants
|
51.5 years
n=107 Participants
|
50.4 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=99 Participants
|
2 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
|
4.6 units on a scale
n=99 Participants
|
4 units on a scale
n=107 Participants
|
4.4 units on a scale
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 weeksAchieving a BICLA response requires to meet all of the following parameters: 1. All British Isles Lupus Assessment Group (BILAG) A scores improving to B/C/D and all BILAG level B scores improving to C/D 2. No single new BILAG A \& not \>1 new BILAG B scores, no worsening of the baseline Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score AND no worsening in the Physician Global Assessment (PGA) (\<10% worsening from baseline) 3. No initiation of non-protocol treatments or premature study discontinuation The range of values for the above instruments are listed below, with higher scores indicating more active disease: BILAG: 0 to 96 SLEDAI: 0 to 105 PGA: 0-3
Outcome measures
| Measure |
TENS for Vagus Stimulation
n=5 Participants
A transcutaneous electrical nerve stimulation (TENS) unit is applied to tragus, the area of the external ear innervated by the auricular branch of the vagus nerve.
TENS for vagus stimulation: TENS electrodes are applied the tragus of the external ear.
|
TENS for Sham Stimulation
n=2 Participants
A TENS unit is applied to the earlobe, an area of the external ear that is devoid of vagus innervation.
TENS for sham stimulation: TENS electrodes are applied on the earlobe.
|
|---|---|---|
|
Percentage of Participants on Active vs Sham tVNS With Improvement in SLE Disease Activity by the BILAG-based Combined Lupus Assessment (BICLA)
BICLA responders
|
1 Participants
|
0 Participants
|
|
Percentage of Participants on Active vs Sham tVNS With Improvement in SLE Disease Activity by the BILAG-based Combined Lupus Assessment (BICLA)
BICLA non responders
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: all patients randomized to active treatment or placebo that had a total SLEDAI score of at least 4 at baseline.
SRI requires meeting all of the following parameters: 1. ≥4-point reduction from baseline in the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score 2. No single new British Isles Lupus Assessment Group (BILAG) A score \& not \>1 new BILAG B scores AND no worsening in the Physician Global Assessment (PGA) (\<10% worsening from baseline) 3. No initiation of non-protocol treatments or premature study discontinuation The range of values for the above instruments are listed below, with higher scores indicating more active disease: BILAG: 0 to 96 SLEDAI: 0 to 108 PGA: 0-3
Outcome measures
| Measure |
TENS for Vagus Stimulation
n=4 Participants
A transcutaneous electrical nerve stimulation (TENS) unit is applied to tragus, the area of the external ear innervated by the auricular branch of the vagus nerve.
TENS for vagus stimulation: TENS electrodes are applied the tragus of the external ear.
|
TENS for Sham Stimulation
n=2 Participants
A TENS unit is applied to the earlobe, an area of the external ear that is devoid of vagus innervation.
TENS for sham stimulation: TENS electrodes are applied on the earlobe.
|
|---|---|---|
|
Percentage of Participants on Active vs Sham tVNS With Improvement in SLE Disease Activity by the Systemic Lupus Erythematosus Responder Index (SRI-4)
SRI Responders
|
0 Participants
|
0 Participants
|
|
Percentage of Participants on Active vs Sham tVNS With Improvement in SLE Disease Activity by the Systemic Lupus Erythematosus Responder Index (SRI-4)
SRI Non-responders
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Analysis not done.
HRV is measured by time domain (RMSSD and pNN50) and frequency domain \[high frequency (HF), low to high frequency (LF/HF) ratio\] parameters.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksPopulation: Analysis has not been done.
The SELENA SLEDAI flare index captures flares in the preceding 30 days by a combination of clinical descriptors and medications rules.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksPopulation: Analysis not done.
The Lupus QoL is a patient reported outcome developed for measurement of quality of life of patients with SLE in clinical research
Outcome measures
Outcome data not reported
Adverse Events
TENS for Vagus Stimulation
TENS for Sham Stimulation
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TENS for Vagus Stimulation
n=5 participants at risk
A transcutaneous electrical nerve stimulation (TENS) unit is applied to tragus, the area of the external ear innervated by the auricular branch of the vagus nerve.
TENS for vagus stimulation: TENS electrodes are applied the tragus of the external ear.
|
TENS for Sham Stimulation
n=2 participants at risk
A TENS unit is applied to the earlobe, an area of the external ear that is devoid of vagus innervation.
TENS for sham stimulation: TENS electrodes are applied on the earlobe.
|
|---|---|---|
|
Renal and urinary disorders
Urinary tract infections
|
20.0%
1/5 • Number of events 1 • 12 weeks (baseline to Month 3)
|
0.00%
0/2 • 12 weeks (baseline to Month 3)
|
|
Nervous system disorders
headache
|
20.0%
1/5 • Number of events 1 • 12 weeks (baseline to Month 3)
|
50.0%
1/2 • Number of events 1 • 12 weeks (baseline to Month 3)
|
|
Gastrointestinal disorders
nausea
|
20.0%
1/5 • Number of events 1 • 12 weeks (baseline to Month 3)
|
0.00%
0/2 • 12 weeks (baseline to Month 3)
|
|
Nervous system disorders
paresthesias
|
0.00%
0/5 • 12 weeks (baseline to Month 3)
|
50.0%
1/2 • Number of events 1 • 12 weeks (baseline to Month 3)
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
20.0%
1/5 • Number of events 1 • 12 weeks (baseline to Month 3)
|
0.00%
0/2 • 12 weeks (baseline to Month 3)
|
|
Nervous system disorders
carpal tunnel syndrome
|
20.0%
1/5 • Number of events 1 • 12 weeks (baseline to Month 3)
|
0.00%
0/2 • 12 weeks (baseline to Month 3)
|
Additional Information
Aikaterini Thanou, MD
Oklahoma Medical Research Foundation
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place