Trial Outcomes & Findings for BreEStim and tDCS for Neuropathic Pain Management - Healthy Subjects (NCT NCT03302780)
NCT ID: NCT03302780
Last Updated: 2021-04-27
Results Overview
Electrical Pain Threshold (EPT) is a type of quantitative sensory test that assesses the lowest electrical current that first evokes a sensation of pricking pain.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
baseline, 10 minutes after tDCS, 10 minutes after BreEstim
Results posted on
2021-04-27
Participant Flow
Participant milestones
| Measure |
Sham tDCS and BreEStim; Then M1 tDCS and BreEstim
This study has a single-blinded, single-center, sham-controlled, crossover design. It included 2 separate visits, each with either a 20-min sham tDCS or M1 tDCS to the current dominant primary motor cortex(M1), both followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.
|
M1 tDCS and BreEStim; Then Sham tDCS and BreEstim
This study has a single-blinded, single-center, sham-controlled, crossover design. It included 2 separate visits, each with either a 20-min sham tDCS or M1 tDCS to the current dominant primary motor cortex(M1), both followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BreEStim and tDCS for Neuropathic Pain Management - Healthy Subjects
Baseline characteristics by cohort
| Measure |
All Participants
n=6 Participants
This study has a single-blinded, single-center, sham-controlled, crossover design. It included 2 separate visits, each with either a 20-min sham tDCS or M1 tDCS to the current dominant primary motor cortex(M1), both followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
34 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 10 minutes after tDCS, 10 minutes after BreEstimElectrical Pain Threshold (EPT) is a type of quantitative sensory test that assesses the lowest electrical current that first evokes a sensation of pricking pain.
Outcome measures
| Measure |
Sham tDCS and BreEStim
n=6 Participants
This study has a single-blinded, single-center, sham-controlled, crossover design. It included a 20-min sham tDCS to the current dominant primary motor cortex(M1), followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.
|
Active tDCS (M1) and BreEStim
n=6 Participants
This study has a single-blinded, single-center, sham-controlled, crossover design. It included a 20-min active tDCS to the current dominant primary motor cortex(M1), followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.
|
|---|---|---|
|
Electrical Pain Threshold (EPT)
Baseline
|
23.83 mA
Standard Deviation 6.79
|
22.41 mA
Standard Deviation 4.67
|
|
Electrical Pain Threshold (EPT)
After tDCS
|
24.08 mA
Standard Deviation 7.68
|
20.41 mA
Standard Deviation 3.01
|
|
Electrical Pain Threshold (EPT)
After BreEstim
|
26.70 mA
Standard Deviation 7.68
|
23.77 mA
Standard Deviation 6.78
|
PRIMARY outcome
Timeframe: baseline, 10 minutes after tDCS, 10 minutes after BreEstimElectrical Detection Threshold (EDT) is a type of Quantitative sensory test that assesses the lowest electrical current that first evokes an electrical sensation.
Outcome measures
| Measure |
Sham tDCS and BreEStim
n=6 Participants
This study has a single-blinded, single-center, sham-controlled, crossover design. It included a 20-min sham tDCS to the current dominant primary motor cortex(M1), followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.
|
Active tDCS (M1) and BreEStim
n=6 Participants
This study has a single-blinded, single-center, sham-controlled, crossover design. It included a 20-min active tDCS to the current dominant primary motor cortex(M1), followed by a 20-min BreEStim to the median nerve(160 times) transcutaneously on the current dominant side.
|
|---|---|---|
|
Electrical Sensation Threshold (EST)
Baseline
|
4.05 mA
Standard Deviation 1.07
|
3.54 mA
Standard Deviation 0.92
|
|
Electrical Sensation Threshold (EST)
After tDCS
|
3.99 mA
Standard Deviation 0.86
|
3.39 mA
Standard Deviation 0.53
|
|
Electrical Sensation Threshold (EST)
After BreEstim
|
3.95 mA
Standard Deviation 0.74
|
3.59 mA
Standard Deviation 0.64
|
Adverse Events
Sham tDCS and BreEStim
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active tDCS (M1) and BreEStim
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sheng Li, MD, PhD
University of Texas McGovern Medical School - Houston
Phone: 7137977125
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place