Trial Outcomes & Findings for Modulating Human Cortical Plasticity With Transcranial Electrical Stimulation (NCT NCT03114488)
NCT ID: NCT03114488
Last Updated: 2020-02-10
Results Overview
The amplitude of the N100 component will be averaged across individuals in each group. Grand averages from the two groups will be compared. Outcome is reported as the change from baseline to post-treatment (approximately 1 hour).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
approximately 1 hour
Results posted on
2020-02-10
Participant Flow
Participant milestones
| Measure |
Active tDCS First, Then Sham
Participants randomized to active tDCS first, then the sham treatment
|
Sham tDCS First, Then Active
Participants randomized to sham tDCS first, then the active treatment
|
|---|---|---|
|
Time Period 1
STARTED
|
19
|
22
|
|
Time Period 1
COMPLETED
|
19
|
22
|
|
Time Period 1
NOT COMPLETED
|
0
|
0
|
|
Time Period 2
STARTED
|
19
|
22
|
|
Time Period 2
COMPLETED
|
18
|
19
|
|
Time Period 2
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Active tDCS First, Then Sham
Participants randomized to active tDCS first, then the sham treatment
|
Sham tDCS First, Then Active
Participants randomized to sham tDCS first, then the active treatment
|
|---|---|---|
|
Time Period 2
Withdrawal by Subject
|
1
|
3
|
Baseline Characteristics
Modulating Human Cortical Plasticity With Transcranial Electrical Stimulation
Baseline characteristics by cohort
| Measure |
All Participants
n=41 Participants
Crossover Design: All participants are included in baseline analysis.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
27.1 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: approximately 1 hourThe amplitude of the N100 component will be averaged across individuals in each group. Grand averages from the two groups will be compared. Outcome is reported as the change from baseline to post-treatment (approximately 1 hour).
Outcome measures
| Measure |
Anodal Stimulation - Time Period 1
n=19 Participants
Change from baseline to post-treatment of Amplitude of N100 component of the Auditory Evoked potential
Crossover design, experimental stimulation arm - time period 1
|
Sham Stimulation - Time Period 1
n=22 Participants
Change from baseline to post-treatment of Amplitude of N100 component of the Auditory Evoked potential
Crossover design, sham stimulation arm - time period 1
|
Anodal Stimulation - Time Period 2
n=18 Participants
Change from baseline to post-treatment of Amplitude of N100 component of the Auditory Evoked potential
Crossover design, experimental stimulation arm - time period 2
|
Sham Stimulation - Time Period 2
n=19 Participants
Change from baseline to post-treatment of Amplitude of N100 component of the Auditory Evoked potential
Crossover design, sham stimulation arm - time period 2
|
|---|---|---|---|---|
|
Change in Amplitude of N100 Component of the Auditory Evoked Potential
|
-1.1 microvolts
Standard Deviation 1.18
|
-0.35 microvolts
Standard Deviation 0.543
|
-0.77 microvolts
Standard Deviation 1.22
|
-0.33 microvolts
Standard Deviation 0.661
|
Adverse Events
Anodal Stimulation - Time Period 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Stimulation - Time Period 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Anodal Stimulation - Time Period 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Stimulation - Time Period 2
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place