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Trial Outcomes & Findings for Brain Stimulation and Hand Training in Children With Hemiparesis (NCT NCT02250092)

NCT ID: NCT02250092

Last Updated: 2020-08-18

Results Overview

Participants were videotaped while performing a bimanual age-appropriate activity. Investigators scored this performance using the Assessment of Assisting Hand (AHA) inventory. The AHA consists of 22 items, each scored on a 4-point scale. Raw scores are a sum of the 22 item scores, ranging from 22-88. Computer software logarithmically transforms ordinal raw scores into a final score. Final scores are reported on a logit-based AHA-unit scale and range from 0 to 100, with higher scores indicating greater ability. Outcome is reported as the change from baseline to 2 weeks and change from baseline to 6 months.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

2 weeks, 6 months

Results posted on

2020-08-18

Participant Flow

Participant milestones

Participant milestones
Measure
tDCS/CIMT
Intervention Group will receive 20 minutes of 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT. Transcranial Direct Current Stimulation (tDCS): 10 tDCS/CIMT Sessions
tDCS Sham/CIMT
Placebo Group will receive 20 minutes of sham 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT. Placebo Comparator
Overall Study
STARTED
10
10
Overall Study
COMPLETED
10
10
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Brain Stimulation and Hand Training in Children With Hemiparesis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
tDCS/CIMT
n=10 Participants
Intervention Group will receive 20 minutes of 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT. Transcranial Direct Current Stimulation (tDCS): 10 tDCS/CIMT Sessions
tDCS Sham/CIMT
n=10 Participants
Placebo Group will receive 20 minutes of sham 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT. Placebo Comparator
Total
n=20 Participants
Total of all reporting groups
Age, Categorical
<=18 years
10 Participants
n=93 Participants
8 Participants
n=4 Participants
18 Participants
n=27 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=93 Participants
2 Participants
n=4 Participants
2 Participants
n=27 Participants
Age, Categorical
>=65 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Age, Continuous
12.33 years
STANDARD_DEVIATION 3.08 • n=93 Participants
13.17 years
STANDARD_DEVIATION 5.08 • n=4 Participants
12.7 years
STANDARD_DEVIATION 4.17 • n=27 Participants
Sex: Female, Male
Female
5 Participants
n=93 Participants
6 Participants
n=4 Participants
11 Participants
n=27 Participants
Sex: Female, Male
Male
5 Participants
n=93 Participants
4 Participants
n=4 Participants
9 Participants
n=27 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Race (NIH/OMB)
Asian
0 Participants
n=93 Participants
10 Participants
n=4 Participants
10 Participants
n=27 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Race (NIH/OMB)
White
8 Participants
n=93 Participants
0 Participants
n=4 Participants
8 Participants
n=27 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
n=93 Participants
0 Participants
n=4 Participants
2 Participants
n=27 Participants
Region of Enrollment
United States
10 participants
n=93 Participants
10 participants
n=4 Participants
20 participants
n=27 Participants

PRIMARY outcome

Timeframe: 2 weeks, 6 months

Participants were videotaped while performing a bimanual age-appropriate activity. Investigators scored this performance using the Assessment of Assisting Hand (AHA) inventory. The AHA consists of 22 items, each scored on a 4-point scale. Raw scores are a sum of the 22 item scores, ranging from 22-88. Computer software logarithmically transforms ordinal raw scores into a final score. Final scores are reported on a logit-based AHA-unit scale and range from 0 to 100, with higher scores indicating greater ability. Outcome is reported as the change from baseline to 2 weeks and change from baseline to 6 months.

Outcome measures

Outcome measures
Measure
tDCS/CIMT
n=10 Participants
Intervention Group will receive 20 minutes of 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT. Transcranial Direct Current Stimulation (tDCS): 10 tDCS/CIMT Sessions
tDCS Sham/CIMT
n=10 Participants
Placebo Group will receive 20 minutes of sham 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT. Placebo Comparator
Change in Assisting Hand Assessment (AHA)
2 weeks
6.4 score on a scale
Interval 3.4 to 9.4
8 score on a scale
Interval 5.66 to 10.34
Change in Assisting Hand Assessment (AHA)
6 months
5.5 score on a scale
Interval 3.23 to 7.77
7.6 score on a scale
Interval 3.92 to 11.28

SECONDARY outcome

Timeframe: 2 weeks, 6 months

The COPM is clinician-administered semi-structured interview measuring the participant's perception of satisfaction and performance of personally set goals. There are 3 categories (Self-Care, Productivity, and Leisure) each containing 3 subcategories each for a total of 9 items, which are rated on an ordinal scale from 1 (minimum importance) to 10 (maximum importance). Each of the child's goals are given a satisfaction and performance rating. The average of the satisfaction ratings across all goals is reported as the "average satisfaction score", ranging from 1 to 10, with higher scores indicating a better outcome. Outcome is reported as the change from baseline to 2 weeks and change from baseline to 6 months.

Outcome measures

Outcome measures
Measure
tDCS/CIMT
n=10 Participants
Intervention Group will receive 20 minutes of 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT. Transcranial Direct Current Stimulation (tDCS): 10 tDCS/CIMT Sessions
tDCS Sham/CIMT
n=10 Participants
Placebo Group will receive 20 minutes of sham 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT. Placebo Comparator
Change in Canadian Occupational Performance Measurement (COPM)
2 weeks
2.14 score on a scale
Interval 1.23 to 3.05
1.8 score on a scale
Interval 1.27 to 2.33
Change in Canadian Occupational Performance Measurement (COPM)
6 months
2.94 score on a scale
Interval 2.04 to 3.84
3.22 score on a scale
Interval 2.57 to 3.87

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 weeks, 6 months

The Subject Symptom Assessment (SSA) is a questionnaire of common side effects reported in the literature that is asked of the child undergoing non-invasive brain stimulation. This measure asks the child to rate if the symptom is present (yes or no) and if it is present, rate the severity using a 1 to 4 scale (1 indicates absent, 2=mild, 3=moderate, 4=severe). Lower values are better as they represent absent or mild symptoms. Outcome is reported as the change in symptom severity from 2 weeks of treatment to 6 months of treatment. This measure is not collected at baseline.

Outcome measures

Outcome measures
Measure
tDCS/CIMT
n=10 Participants
Intervention Group will receive 20 minutes of 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT. Transcranial Direct Current Stimulation (tDCS): 10 tDCS/CIMT Sessions
tDCS Sham/CIMT
n=10 Participants
Placebo Group will receive 20 minutes of sham 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT. Placebo Comparator
Change in Subject Symptom Assessment (SSA) From 2 Weeks to 6 Months
1.7 score on a scale
Interval 0.5 to 2.9
1.76 score on a scale
Interval 0.96 to 2.56

Adverse Events

tDCS/CIMT

Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths

tDCS Sham/CIMT

Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
tDCS/CIMT
n=10 participants at risk
Intervention Group will receive 20 minutes of 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT. Transcranial Direct Current Stimulation (tDCS): 10 tDCS/CIMT Sessions
tDCS Sham/CIMT
n=10 participants at risk
Placebo Group will receive 20 minutes of sham 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT. Placebo Comparator
General disorders
Headache
40.0%
4/10 • Number of events 9 • 6 months
10.0%
1/10 • Number of events 1 • 6 months
General disorders
Unusual Feelings on the Skin of the Head
20.0%
2/10 • Number of events 5 • 6 months
10.0%
1/10 • Number of events 1 • 6 months
General disorders
Itchiness
10.0%
1/10 • Number of events 5 • 6 months
30.0%
3/10 • Number of events 6 • 6 months
General disorders
Unusual Feelings or Emotions
10.0%
1/10 • Number of events 2 • 6 months
0.00%
0/10 • 6 months
General disorders
Dizziness
0.00%
0/10 • 6 months
30.0%
3/10 • Number of events 3 • 6 months
General disorders
Nausea
0.00%
0/10 • 6 months
10.0%
1/10 • Number of events 1 • 6 months
General disorders
Tingling
20.0%
2/10 • Number of events 10 • 6 months
20.0%
2/10 • Number of events 2 • 6 months
General disorders
Difficulty Paying Attention
0.00%
0/10 • 6 months
10.0%
1/10 • Number of events 1 • 6 months

Additional Information

Bernadette Gillick

University of Minnesota

Phone: 612-626-6415

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place