Trial Outcomes & Findings for Learning Enhancement Through Neurostimulation in Autism (NCT NCT02998684)
NCT ID: NCT02998684
Last Updated: 2018-09-04
Results Overview
Change in TASSK raw scores from pre- to post-treatment, i.e., baseline to 14-weeks (Post minus pre-treatment: positive scores indicate improvement). Assessment scores can range from 0 to 26, 0 being the lowest possible score and 26 being the highest.
COMPLETED
NA
25 participants
Baseline to 14-weeks
2018-09-04
Participant Flow
Participant milestones
| Measure |
Active Transcranial Direct Current Stimulation
Participants will receive active Transcranial Direct Current Stimulation
Active Transcranial Direct Current Stimulation
PEERS Social Skills Training: 14 weekly social skills training sessions for all participants
|
Sham Transcranial Direct Current Stimulation
Participants will receive sham Transcranial Direct Current Stimulation
Sham Transcranial Direct Current Stimulation
PEERS Social Skills Training: 14 weekly social skills training sessions for all participants
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
|
Overall Study
COMPLETED
|
4
|
6
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Learning Enhancement Through Neurostimulation in Autism
Baseline characteristics by cohort
| Measure |
Active Transcranial Direct Current Stimulation
n=7 Participants
Participants will receive active Transcranial Direct Current Stimulation
Active Transcranial Direct Current Stimulation
PEERS Social Skills Training: 14 weekly social skills training sessions for all participants
|
Sham Transcranial Direct Current Stimulation
n=7 Participants
Participants will receive sham Transcranial Direct Current Stimulation
Sham Transcranial Direct Current Stimulation
PEERS Social Skills Training: 14 weekly social skills training sessions for all participants
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=99 Participants
|
7 participants
n=107 Participants
|
14 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to 14-weeksPopulation: Number of participants who completed study questionnaire pre and post-treatment
Change in TASSK raw scores from pre- to post-treatment, i.e., baseline to 14-weeks (Post minus pre-treatment: positive scores indicate improvement). Assessment scores can range from 0 to 26, 0 being the lowest possible score and 26 being the highest.
Outcome measures
| Measure |
Active Transcranial Direct Current Stimulation
n=3 Participants
Participants will receive active Transcranial Direct Current Stimulation
Active Transcranial Direct Current Stimulation
PEERS Social Skills Training: 14 weekly social skills training sessions for all participants
|
Sham Transcranial Direct Current Stimulation
n=6 Participants
Participants will receive sham Transcranial Direct Current Stimulation
Sham Transcranial Direct Current Stimulation
PEERS Social Skills Training: 14 weekly social skills training sessions for all participants
|
|---|---|---|
|
Test of Adolescent Social Skills Knowledge (TASSK)
|
8 score on a scale
Standard Deviation 2
|
3.5 score on a scale
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: Baseline to 14 weeksPopulation: Data for participants who completed all 14 weeks
Change in SRS raw scores from pre- to post-treatment, i.e., baseline to 14-weeks (Pre minus post-treatment: positive scores indicate improvement). Raw scores range from 0 to 195, with higher scores indicating greater severity of symptoms.
Outcome measures
| Measure |
Active Transcranial Direct Current Stimulation
n=4 Participants
Participants will receive active Transcranial Direct Current Stimulation
Active Transcranial Direct Current Stimulation
PEERS Social Skills Training: 14 weekly social skills training sessions for all participants
|
Sham Transcranial Direct Current Stimulation
n=6 Participants
Participants will receive sham Transcranial Direct Current Stimulation
Sham Transcranial Direct Current Stimulation
PEERS Social Skills Training: 14 weekly social skills training sessions for all participants
|
|---|---|---|
|
Social Responsiveness Scale (SRS)
|
23.5 score on a scale
Standard Deviation 18.2
|
26.5 score on a scale
Standard Deviation 22.6
|
Adverse Events
Active Transcranial Direct Current Stimulation
Sham Transcranial Direct Current Stimulation
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