Trial Outcomes & Findings for Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis (NCT NCT01636661)
NCT ID: NCT01636661
Last Updated: 2015-11-09
Results Overview
Assessment of safety of use of tDCS in children with hemiparesis through vital signs, physician evaluation, subject report of symptoms. Reported are the number of participants who met the following criteria: 1. Vital Signs (either resting blood pressure or heart rate)- Any greater than 2SD of change in vital signs from pretest to posttest. 2. Physician Evaluation- Child identified as declining in function from pretest to posttest. 3. Subject Report of Symptoms- Reports of serious adverse event/symptoms from pretest to posttest. Detailed adverse events are reported in the adverse events module.
COMPLETED
EARLY_PHASE1
13 participants
Baseline, Posttest, Follow-Up Session at One-Week
2015-11-09
Participant Flow
If a child did not exhibit a motor evoked potential from the ipsilesional cortex, they were excluded from the trial after enrollment but before assignment to a group.
Participant milestones
| Measure |
Transcranial Direct Current Stimulation
Receiving active tDCS
tDCS: transcranial direct current stimulation- non-invasive brain stimulation
|
Sham tDCS
tDCS equipment set to placebo setting.
tDCS: transcranial direct current stimulation- non-invasive brain stimulation
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
6
|
|
Overall Study
COMPLETED
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis
Baseline characteristics by cohort
| Measure |
Transcranial Direct Current Stimulation
n=5 Participants
Receiving active tDCS
tDCS: transcranial direct current stimulation- non-invasive brain stimulation
|
Sham tDCS
n=6 Participants
tDCS equipment set to placebo setting.
tDCS: transcranial direct current stimulation- non-invasive brain stimulation
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
10.7 years
STANDARD_DEVIATION 3.2 • n=5 Participants
|
16.9 years
STANDARD_DEVIATION 2.6 • n=7 Participants
|
14.7 years
STANDARD_DEVIATION 3.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Posttest, Follow-Up Session at One-WeekPopulation: Pilot study therefore no sample size analysis. Completed per protocol.
Assessment of safety of use of tDCS in children with hemiparesis through vital signs, physician evaluation, subject report of symptoms. Reported are the number of participants who met the following criteria: 1. Vital Signs (either resting blood pressure or heart rate)- Any greater than 2SD of change in vital signs from pretest to posttest. 2. Physician Evaluation- Child identified as declining in function from pretest to posttest. 3. Subject Report of Symptoms- Reports of serious adverse event/symptoms from pretest to posttest. Detailed adverse events are reported in the adverse events module.
Outcome measures
| Measure |
Transcranial Direct Current Stimulation
n=5 Participants
Receiving active tDCS
tDCS: transcranial direct current stimulation- non-invasive brain stimulation
|
Sham tDCS
n=6 Participants
tDCS equipment set to placebo setting.
tDCS: transcranial direct current stimulation- non-invasive brain stimulation
|
|---|---|---|
|
Adverse Events/Safety Assessment.
Any Change in Vital Signs
|
0 Participants
|
0 Participants
|
|
Adverse Events/Safety Assessment.
Decline in Physician Evaluation
|
0 Participants
|
0 Participants
|
|
Adverse Events/Safety Assessment.
Reported Serious Adverse Events
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Posttest, Follow-Up Session at One-WeekMeasured by the Box and Blocks Test and Grip Strength
Outcome measures
| Measure |
Transcranial Direct Current Stimulation
n=5 Participants
Receiving active tDCS
tDCS: transcranial direct current stimulation- non-invasive brain stimulation
|
Sham tDCS
n=6 Participants
tDCS equipment set to placebo setting.
tDCS: transcranial direct current stimulation- non-invasive brain stimulation
|
|---|---|---|
|
Hand Function Decline as Measured by Number of Participants
|
0 participants
|
0 participants
|
Adverse Events
Transcranial Direct Current Stimulation
Sham tDCS
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Transcranial Direct Current Stimulation
n=5 participants at risk
Receiving active tDCS
tDCS: transcranial direct current stimulation- non-invasive brain stimulation
|
Sham tDCS
n=6 participants at risk
tDCS equipment set to placebo setting.
tDCS: transcranial direct current stimulation- non-invasive brain stimulation
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Itching
|
20.0%
1/5 • Number of events 1
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Burning
|
0.00%
0/5
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Sleepiness
|
0.00%
0/5
|
50.0%
3/6 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place