Trial Outcomes & Findings for Motor and Neurophysiological Changes After Ischemic Conditioning in Individuals With Stroke (NCT NCT05906602)
NCT ID: NCT05906602
Last Updated: 2026-05-19
Results Overview
Excitability of the primary lower limb motor cortex will be assessed using single pulse transcranial magnetic stimulation (TMS) and motor evoked potentials (MEPs) will be recorded from the tibialis anterior muscle of the paretic leg. Higher values indicate more corticomotor excitability.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Changes in corticomotor excitability will be calculated within and between sessions at baseline (Pre), immediate-post (Post), and 30-minutes-post (Post-30) one session of sham IC and real IC.
Results posted on
2026-05-19
Participant Flow
22 individuals with stroke were screened for eligibility. Of these, 2 were excluded prior to study procedures due to contraindications to IC. Of the 20 eligible participants, 1 withdrew for health reasons unrelated to study procedures (GI tract discomfort). Thus, 19 participants completed the study and experienced one session of IC and one session of sham-IC. All eligibility assessments and consent were conducted in person before randomization/ IC and sham-IC.
Participant milestones
| Measure |
Ischemic Conditioning Then Sham Ischemic Conditioning
While seated, a rapid inflation cuff, similar to those used to measure blood pressure, will be placed around the paretic thigh to perform real ischemic conditioning. The pressure of the cuff will be increased for 5 minutes followed by no pressure for 5 minutes, repeated 5 times for a total of 50 minutes. After a washout period of at least 1 week, participants will then experience sham ischemic conditioning. While seated, a rapid inflation cuff, similar to those used to measure blood pressure, will be placed around the paretic thigh to perform sham or fake ischemic conditioning. The pressure of the cuff will be increased for 5 minutes followed by no pressure for 5 minutes, repeated 5 times for a total of 50 minutes.
Real Ischemic Conditioning: 10-minute cycles of blood flow restriction (5 minutes) followed by blood flow release (5 minutes), repeated 5 times for a total of 50 minutes.
Sham Ischemic Conditioning: Sham ischemic conditioning will mirror ischemic conditioning procedures, differing solely in cuff pressure during blood flow restriction to replicate to replicate perceived tightness without arterial blood flow restriction.
|
Sham Ischemic Conditioning Then Ischemic Conditioning
While seated, a rapid inflation cuff, similar to those used to measure blood pressure, will be placed around the paretic thigh to perform sham or fake ischemic conditioning. The pressure of the cuff will be increased for 5 minutes followed by no pressure for 5 minutes, repeated 5 times for a total of 50 minutes. After a washout period of at least 1 week, participants will then experience ischemic conditioning. While seated, a rapid inflation cuff, similar to those used to measure blood pressure, will be placed around the paretic thigh to perform real ischemic conditioning. The pressure of the cuff will be increased for 5 minutes followed by no pressure for 5 minutes, repeated 5 times for a total of 50 minutes.
Real Ischemic Conditioning: 10-minute cycles of blood flow restriction (5 minutes) followed by blood flow release (5 minutes), repeated 5 times for a total of 50 minutes.
Sham Ischemic Conditioning: Sham ischemic conditioning will mirror ischemic conditioning procedures, differing solely in cuff pressure during blood flow restriction to replicate to replicate perceived tightness without arterial blood flow restriction.
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|---|---|---|
|
Overall Study
STARTED
|
11
|
9
|
|
Overall Study
COMPLETED
|
11
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Ischemic Conditioning Then Sham Ischemic Conditioning
While seated, a rapid inflation cuff, similar to those used to measure blood pressure, will be placed around the paretic thigh to perform real ischemic conditioning. The pressure of the cuff will be increased for 5 minutes followed by no pressure for 5 minutes, repeated 5 times for a total of 50 minutes. After a washout period of at least 1 week, participants will then experience sham ischemic conditioning. While seated, a rapid inflation cuff, similar to those used to measure blood pressure, will be placed around the paretic thigh to perform sham or fake ischemic conditioning. The pressure of the cuff will be increased for 5 minutes followed by no pressure for 5 minutes, repeated 5 times for a total of 50 minutes.
Real Ischemic Conditioning: 10-minute cycles of blood flow restriction (5 minutes) followed by blood flow release (5 minutes), repeated 5 times for a total of 50 minutes.
Sham Ischemic Conditioning: Sham ischemic conditioning will mirror ischemic conditioning procedures, differing solely in cuff pressure during blood flow restriction to replicate to replicate perceived tightness without arterial blood flow restriction.
|
Sham Ischemic Conditioning Then Ischemic Conditioning
While seated, a rapid inflation cuff, similar to those used to measure blood pressure, will be placed around the paretic thigh to perform sham or fake ischemic conditioning. The pressure of the cuff will be increased for 5 minutes followed by no pressure for 5 minutes, repeated 5 times for a total of 50 minutes. After a washout period of at least 1 week, participants will then experience ischemic conditioning. While seated, a rapid inflation cuff, similar to those used to measure blood pressure, will be placed around the paretic thigh to perform real ischemic conditioning. The pressure of the cuff will be increased for 5 minutes followed by no pressure for 5 minutes, repeated 5 times for a total of 50 minutes.
Real Ischemic Conditioning: 10-minute cycles of blood flow restriction (5 minutes) followed by blood flow release (5 minutes), repeated 5 times for a total of 50 minutes.
Sham Ischemic Conditioning: Sham ischemic conditioning will mirror ischemic conditioning procedures, differing solely in cuff pressure during blood flow restriction to replicate to replicate perceived tightness without arterial blood flow restriction.
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|---|---|---|
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Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Motor and Neurophysiological Changes After Ischemic Conditioning in Individuals With Stroke
Baseline characteristics by cohort
| Measure |
Ischemic Conditioning Then Sham Ischemic Conditioning
n=11 Participants
While seated, a rapid inflation cuff, similar to those used to measure blood pressure, will be placed around the paretic thigh to perform real ischemic conditioning. The pressure of the cuff will be increased for 5 minutes followed by no pressure for 5 minutes, repeated 5 times for a total of 50 minutes. After a washout period of at least 1 week, participants will then experience sham ischemic conditioning. While seated, a rapid inflation cuff, similar to those used to measure blood pressure, will be placed around the paretic thigh to perform sham or fake ischemic conditioning. The pressure of the cuff will be increased for 5 minutes followed by no pressure for 5 minutes, repeated 5 times for a total of 50 minutes.
Real Ischemic Conditioning: 10-minute cycles of blood flow restriction (5 minutes) followed by blood flow release (5 minutes), repeated 5 times for a total of 50 minutes.
Sham Ischemic Conditioning: Sham ischemic conditioning will mirror ischemic conditioning procedures, differing solely in cuff pressure during blood flow restriction to replicate to replicate perceived tightness without arterial blood flow restriction.
|
Sham Ischemic Conditioning Then Ischemic Conditioning
n=8 Participants
While seated, a rapid inflation cuff, similar to those used to measure blood pressure, will be placed around the paretic thigh to perform sham or fake ischemic conditioning. The pressure of the cuff will be increased for 5 minutes followed by no pressure for 5 minutes, repeated 5 times for a total of 50 minutes. After a washout period of at least 1 week, participants will then experience ischemic conditioning. While seated, a rapid inflation cuff, similar to those used to measure blood pressure, will be placed around the paretic thigh to perform real ischemic conditioning. The pressure of the cuff will be increased for 5 minutes followed by no pressure for 5 minutes, repeated 5 times for a total of 50 minutes.
Real Ischemic Conditioning: 10-minute cycles of blood flow restriction (5 minutes) followed by blood flow release (5 minutes), repeated 5 times for a total of 50 minutes.
Sham Ischemic Conditioning: Sham ischemic conditioning will mirror ischemic conditioning procedures, differing solely in cuff pressure during blood flow restriction to replicate to replicate perceived tightness without arterial blood flow restriction.
|
Total
n=19 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Customized
Age
|
62.27 years
STANDARD_DEVIATION 5.0 • n=30 Participants
|
59.0 years
STANDARD_DEVIATION 9.1 • n=30 Participants
|
60.9 years
STANDARD_DEVIATION 7.0 • n=60 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Male
|
8 Participants
n=30 Participants
|
7 Participants
n=30 Participants
|
15 Participants
n=60 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Female
|
3 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
4 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Caucasian
|
1 Participants
n=30 Participants
|
3 Participants
n=30 Participants
|
4 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Black
|
7 Participants
n=30 Participants
|
3 Participants
n=30 Participants
|
10 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic/Latino
|
2 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
4 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Asian
|
1 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=30 Participants
|
8 Participants
n=30 Participants
|
19 Participants
n=60 Participants
|
|
Limb occlusion pressure
|
193.72 mmHg
STANDARD_DEVIATION 24.6 • n=30 Participants
|
198.88 mmHg
STANDARD_DEVIATION 12.1 • n=30 Participants
|
195.9 mmHg
STANDARD_DEVIATION 20.0 • n=60 Participants
|
|
Mini-Mental State Examination (MMSE)
|
28.6 units on a scale
STANDARD_DEVIATION 2.0 • n=30 Participants
|
28.6 units on a scale
STANDARD_DEVIATION 2.5 • n=30 Participants
|
28.6 units on a scale
STANDARD_DEVIATION 2.1 • n=60 Participants
|
|
Paretic FMLE
|
21.3 units on a scale
STANDARD_DEVIATION 7.5 • n=30 Participants
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23.6 units on a scale
STANDARD_DEVIATION 4.9 • n=30 Participants
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22.3 units on a scale
STANDARD_DEVIATION 6.4 • n=60 Participants
|
|
Ankle range of motion
Dorsiflexion
|
4.9 degrees
STANDARD_DEVIATION 8.3 • n=30 Participants
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7.3 degrees
STANDARD_DEVIATION 8.5 • n=30 Participants
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5.9 degrees
STANDARD_DEVIATION 8.2 • n=60 Participants
|
|
Ankle range of motion
Plantarflexion
|
23.6 degrees
STANDARD_DEVIATION 15.3 • n=30 Participants
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17.4 degrees
STANDARD_DEVIATION 9.2 • n=30 Participants
|
21.1 degrees
STANDARD_DEVIATION 13.3 • n=60 Participants
|
|
Modified Rankin Scale
|
2.2 units on a scale
STANDARD_DEVIATION 0.8 • n=30 Participants
|
2.7 units on a scale
STANDARD_DEVIATION 0.8 • n=30 Participants
|
2.4 units on a scale
STANDARD_DEVIATION 0.8 • n=60 Participants
|
|
Gait Speed
|
1.3 m/s
STANDARD_DEVIATION 0.44 • n=30 Participants
|
1.3 m/s
STANDARD_DEVIATION 0.6 • n=30 Participants
|
1.3 m/s
STANDARD_DEVIATION 0.49 • n=60 Participants
|
|
Endurance
|
303.7 m
STANDARD_DEVIATION 119.4 • n=30 Participants
|
343.3 m
STANDARD_DEVIATION 184.0 • n=30 Participants
|
319.1 m
STANDARD_DEVIATION 143.9 • n=60 Participants
|
PRIMARY outcome
Timeframe: Changes in corticomotor excitability will be calculated within and between sessions at baseline (Pre), immediate-post (Post), and 30-minutes-post (Post-30) one session of sham IC and real IC.Population: All participants (n=19) who completed one session of real IC and one session of sham IC were analyzed. Participants (n=1) who withdrew from the study or did not complete the interventions were not included in the analyses.
Excitability of the primary lower limb motor cortex will be assessed using single pulse transcranial magnetic stimulation (TMS) and motor evoked potentials (MEPs) will be recorded from the tibialis anterior muscle of the paretic leg. Higher values indicate more corticomotor excitability.
Outcome measures
| Measure |
Ischemic Conditioning
n=19 Participants
While seated, a rapid inflation cuff, similar to those used to measure blood pressure, will be placed around the paretic thigh to perform real ischemic conditioning. The pressure of the cuff will be increased for 5 minutes followed by no pressure for 5 minutes, repeated 5 times for a total of 50 minutes.
Real Ischemic Conditioning: 10-minute cycles of blood flow restriction (5 minutes) followed by blood flow release (5 minutes), repeated 5 times for a total of 50 minutes.
|
Sham Ischemic Conditioning
n=19 Participants
While seated, a rapid inflation cuff, similar to those used to measure blood pressure, will be placed around the paretic thigh to perform sham or fake ischemic conditioning. The pressure of the cuff will be increased for 5 minutes followed by no pressure for 5 minutes, repeated 5 times for a total of 50 minutes.
Sham Ischemic Conditioning: Sham ischemic conditioning will mirror ischemic conditioning procedures, differing solely in cuff pressure during blood flow restriction to replicate to replicate perceived tightness without arterial blood flow restriction.
|
|---|---|---|
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Change in Corticomotor Excitability
Post
|
0.38 millivolt (mV)
Standard Deviation 0.24
|
0.37 millivolt (mV)
Standard Deviation 0.28
|
|
Change in Corticomotor Excitability
Post-30
|
0.41 millivolt (mV)
Standard Deviation 0.27
|
0.37 millivolt (mV)
Standard Deviation 0.27
|
PRIMARY outcome
Timeframe: Changes in transcallosal inhibition will be calculated within and between sessions at baseline (Pre), immediate-post (Post), and 30-minutes-post (Post-30) one session of sham IC and real IC.Population: All participants (n=19) who completed one session of real IC and one session of sham IC were analyzed. Participants (n=1) who withdrew from the study or did not complete the interventions were not included in the analyses.
Inhibition from the stimulated hemisphere to the non-stimulated hemisphere will be quantified as a measure of the ipsilateral silent period (iSP) using single pulse transcranial magnetic stimulation (TMS) and motor evoked potentials (MEPs) will be recorded from the tibialis anterior muscle of the leg ipsilateral to TMS stimulation. Higher values indicate more inhibition from the stimulated hemisphere to the non-stimulated hemisphere.
Outcome measures
| Measure |
Ischemic Conditioning
n=19 Participants
While seated, a rapid inflation cuff, similar to those used to measure blood pressure, will be placed around the paretic thigh to perform real ischemic conditioning. The pressure of the cuff will be increased for 5 minutes followed by no pressure for 5 minutes, repeated 5 times for a total of 50 minutes.
Real Ischemic Conditioning: 10-minute cycles of blood flow restriction (5 minutes) followed by blood flow release (5 minutes), repeated 5 times for a total of 50 minutes.
|
Sham Ischemic Conditioning
n=19 Participants
While seated, a rapid inflation cuff, similar to those used to measure blood pressure, will be placed around the paretic thigh to perform sham or fake ischemic conditioning. The pressure of the cuff will be increased for 5 minutes followed by no pressure for 5 minutes, repeated 5 times for a total of 50 minutes.
Sham Ischemic Conditioning: Sham ischemic conditioning will mirror ischemic conditioning procedures, differing solely in cuff pressure during blood flow restriction to replicate to replicate perceived tightness without arterial blood flow restriction.
|
|---|---|---|
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Change in Transcallosal Inhibition
Post
|
133.1 ms
Standard Deviation 57.1
|
113.3 ms
Standard Deviation 64.3
|
|
Change in Transcallosal Inhibition
Post-30
|
133.9 ms
Standard Deviation 62.8
|
118.8 ms
Standard Deviation 66.2
|
PRIMARY outcome
Timeframe: Changes in ankle motor control will be calculated within and between sessions at baseline (Pre), immediate-post (Post), and 30-minutes-post (Post-30) one session of sham IC and real IC.Population: All participants (n=19) who completed one session of real IC and one session of sham IC were analyzed. Participants (n=1) who withdrew from the study or did not complete the interventions were not included in the analyses.
Reaction time will be measured using a choice reaction time task involving rapid ankle dorsiflexion and plantarflexion movements in a custom built ankle-tracking device. Lower values reflect faster reaction times. Only dorsiflexion trials were analyzed to isolate TA activation, while both directions were included to minimize anticipatory activity.
Outcome measures
| Measure |
Ischemic Conditioning
n=19 Participants
While seated, a rapid inflation cuff, similar to those used to measure blood pressure, will be placed around the paretic thigh to perform real ischemic conditioning. The pressure of the cuff will be increased for 5 minutes followed by no pressure for 5 minutes, repeated 5 times for a total of 50 minutes.
Real Ischemic Conditioning: 10-minute cycles of blood flow restriction (5 minutes) followed by blood flow release (5 minutes), repeated 5 times for a total of 50 minutes.
|
Sham Ischemic Conditioning
n=19 Participants
While seated, a rapid inflation cuff, similar to those used to measure blood pressure, will be placed around the paretic thigh to perform sham or fake ischemic conditioning. The pressure of the cuff will be increased for 5 minutes followed by no pressure for 5 minutes, repeated 5 times for a total of 50 minutes.
Sham Ischemic Conditioning: Sham ischemic conditioning will mirror ischemic conditioning procedures, differing solely in cuff pressure during blood flow restriction to replicate to replicate perceived tightness without arterial blood flow restriction.
|
|---|---|---|
|
Change in Ankle Motor Control
Post
|
0.55 ms
Standard Deviation 0.24
|
0.58 ms
Standard Deviation 0.22
|
|
Change in Ankle Motor Control
Post-30
|
0.52 ms
Standard Deviation 0.21
|
0.53 ms
Standard Deviation 0.17
|
PRIMARY outcome
Timeframe: Changes in strength will be calculated within and between sessions at baseline (Pre), immediate-post (Post), and 30-minutes-post (Post-30) one session of sham IC and real IC.Population: All participants (n=19) who completed one session of real IC and one session of sham IC were analyzed. Participants (n=1) who withdrew from the study or did not complete the interventions were not included in the analyses.
Participants will perform 3 trials each of maximum ankle dorsiflexion and plantarflexion strength. Higher values reflect more strength.
Outcome measures
| Measure |
Ischemic Conditioning
n=19 Participants
While seated, a rapid inflation cuff, similar to those used to measure blood pressure, will be placed around the paretic thigh to perform real ischemic conditioning. The pressure of the cuff will be increased for 5 minutes followed by no pressure for 5 minutes, repeated 5 times for a total of 50 minutes.
Real Ischemic Conditioning: 10-minute cycles of blood flow restriction (5 minutes) followed by blood flow release (5 minutes), repeated 5 times for a total of 50 minutes.
|
Sham Ischemic Conditioning
n=19 Participants
While seated, a rapid inflation cuff, similar to those used to measure blood pressure, will be placed around the paretic thigh to perform sham or fake ischemic conditioning. The pressure of the cuff will be increased for 5 minutes followed by no pressure for 5 minutes, repeated 5 times for a total of 50 minutes.
Sham Ischemic Conditioning: Sham ischemic conditioning will mirror ischemic conditioning procedures, differing solely in cuff pressure during blood flow restriction to replicate to replicate perceived tightness without arterial blood flow restriction.
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|---|---|---|
|
Change in Lower Limb Strength
Plantarflexion Post-30
|
4.0 pound-force (lbf)
Standard Deviation 1.8
|
3.7 pound-force (lbf)
Standard Deviation 1.6
|
|
Change in Lower Limb Strength
Dorsiflexion Post
|
4.6 pound-force (lbf)
Standard Deviation 1.3
|
4.3 pound-force (lbf)
Standard Deviation 1.0
|
|
Change in Lower Limb Strength
Dorsiflexion Post-30
|
4.7 pound-force (lbf)
Standard Deviation 1.4
|
4.3 pound-force (lbf)
Standard Deviation 1.0
|
|
Change in Lower Limb Strength
Plantarflexion Post
|
4.3 pound-force (lbf)
Standard Deviation 1.9
|
3.6 pound-force (lbf)
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: During each real and sham ischemic conditioning session. Ratings from each session will be averaged for each participant, and the final value will represent the mean pain rating across all participants for each experimental condition.Population: All participants (n=19) who completed one session of real IC and one session of sham IC were analyzed. Participants (n=1) who withdrew from the study or did not complete the interventions were not included in the analyses.
Subjective measures of pain will be reported during ischemic conditioning and sham ischemic conditioning using a Numerical Rating Scale (NRS) from 0 (no pain) to 10 (worst pain). Ratings from each session will be averaged for each participant, and the final value will represent the mean pain rating across all participants for each experimental condition.
Outcome measures
| Measure |
Ischemic Conditioning
n=19 Participants
While seated, a rapid inflation cuff, similar to those used to measure blood pressure, will be placed around the paretic thigh to perform real ischemic conditioning. The pressure of the cuff will be increased for 5 minutes followed by no pressure for 5 minutes, repeated 5 times for a total of 50 minutes.
Real Ischemic Conditioning: 10-minute cycles of blood flow restriction (5 minutes) followed by blood flow release (5 minutes), repeated 5 times for a total of 50 minutes.
|
Sham Ischemic Conditioning
n=19 Participants
While seated, a rapid inflation cuff, similar to those used to measure blood pressure, will be placed around the paretic thigh to perform sham or fake ischemic conditioning. The pressure of the cuff will be increased for 5 minutes followed by no pressure for 5 minutes, repeated 5 times for a total of 50 minutes.
Sham Ischemic Conditioning: Sham ischemic conditioning will mirror ischemic conditioning procedures, differing solely in cuff pressure during blood flow restriction to replicate to replicate perceived tightness without arterial blood flow restriction.
|
|---|---|---|
|
Numerical Rating Scale (NRS) for Pain
|
1.1 score on a scale
Interval 0.0 to 10.0
|
1 score on a scale
Interval 0.0 to 10.0
|
Adverse Events
Ischemic Conditioning
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Sham Ischemic Conditioning
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 |
Ischemic Conditioning
n=19 participants at risk
While seated, a rapid inflation cuff, similar to those used to measure blood pressure, will be placed around the paretic thigh to perform real ischemic conditioning. The pressure of the cuff will be increased for 5 minutes followed by no pressure for 5 minutes, repeated 5 times for a total of 50 minutes.
Real Ischemic Conditioning: 10-minute cycles of blood flow restriction (5 minutes) followed by blood flow release (5 minutes), repeated 5 times for a total of 50 minutes.
|
Sham Ischemic Conditioning
n=19 participants at risk
While seated, a rapid inflation cuff, similar to those used to measure blood pressure, will be placed around the paretic thigh to perform sham or fake ischemic conditioning. The pressure of the cuff will be increased for 5 minutes followed by no pressure for 5 minutes, repeated 5 times for a total of 50 minutes.
Sham Ischemic Conditioning: Sham ischemic conditioning will mirror ischemic conditioning procedures, differing solely in cuff pressure during blood flow restriction to replicate to replicate perceived tightness without arterial blood flow restriction.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Tingling
|
21.1%
4/19 • Per participant: 1 week between interventions (real IC and sham IC), totaling 2 weeks.
Adverse events were monitored during each real IC and sham IC session using a structured questionnaire. Participants rated local and systemic symptoms (e.g., tingling, numbness) on a 0-4 scale. Definitions of adverse and serious adverse events aligned with ClinicalTrials.gov guidelines.
|
0.00%
0/19 • Per participant: 1 week between interventions (real IC and sham IC), totaling 2 weeks.
Adverse events were monitored during each real IC and sham IC session using a structured questionnaire. Participants rated local and systemic symptoms (e.g., tingling, numbness) on a 0-4 scale. Definitions of adverse and serious adverse events aligned with ClinicalTrials.gov guidelines.
|
|
Nervous system disorders
Numbness
|
10.5%
2/19 • Per participant: 1 week between interventions (real IC and sham IC), totaling 2 weeks.
Adverse events were monitored during each real IC and sham IC session using a structured questionnaire. Participants rated local and systemic symptoms (e.g., tingling, numbness) on a 0-4 scale. Definitions of adverse and serious adverse events aligned with ClinicalTrials.gov guidelines.
|
0.00%
0/19 • Per participant: 1 week between interventions (real IC and sham IC), totaling 2 weeks.
Adverse events were monitored during each real IC and sham IC session using a structured questionnaire. Participants rated local and systemic symptoms (e.g., tingling, numbness) on a 0-4 scale. Definitions of adverse and serious adverse events aligned with ClinicalTrials.gov guidelines.
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
5.3%
1/19 • Per participant: 1 week between interventions (real IC and sham IC), totaling 2 weeks.
Adverse events were monitored during each real IC and sham IC session using a structured questionnaire. Participants rated local and systemic symptoms (e.g., tingling, numbness) on a 0-4 scale. Definitions of adverse and serious adverse events aligned with ClinicalTrials.gov guidelines.
|
0.00%
0/19 • Per participant: 1 week between interventions (real IC and sham IC), totaling 2 weeks.
Adverse events were monitored during each real IC and sham IC session using a structured questionnaire. Participants rated local and systemic symptoms (e.g., tingling, numbness) on a 0-4 scale. Definitions of adverse and serious adverse events aligned with ClinicalTrials.gov guidelines.
|
|
Skin and subcutaneous tissue disorders
Discomfort
|
5.3%
1/19 • Per participant: 1 week between interventions (real IC and sham IC), totaling 2 weeks.
Adverse events were monitored during each real IC and sham IC session using a structured questionnaire. Participants rated local and systemic symptoms (e.g., tingling, numbness) on a 0-4 scale. Definitions of adverse and serious adverse events aligned with ClinicalTrials.gov guidelines.
|
0.00%
0/19 • Per participant: 1 week between interventions (real IC and sham IC), totaling 2 weeks.
Adverse events were monitored during each real IC and sham IC session using a structured questionnaire. Participants rated local and systemic symptoms (e.g., tingling, numbness) on a 0-4 scale. Definitions of adverse and serious adverse events aligned with ClinicalTrials.gov guidelines.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place