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Trial record 8 of 24 for:    Developmental Disabilities | ( Map: South Carolina, United States )

Learning Enhancement Through Neurostimulation in Autism (LENS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02998684
Recruitment Status : Completed
First Posted : December 20, 2016
Results First Posted : September 3, 2018
Last Update Posted : September 3, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Medical University of South Carolina

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Autism
Interventions Device: Active Transcranial Direct Current Stimulation
Device: Sham Transcranial Direct Current Stimulation
Behavioral: PEERS Social Skills Training
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Active Transcranial Direct Current Stimulation Sham Transcranial Direct Current Stimulation
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 7 7
Completed 4 6
Not Completed 3 1
Arm/Group Title Active Transcranial Direct Current Stimulation Sham Transcranial Direct Current Stimulation Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 7 7 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 14 participants
<=18 years
6
  85.7%
7
 100.0%
13
  92.9%
Between 18 and 65 years
1
  14.3%
0
   0.0%
1
   7.1%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 14 participants
Female
2
  28.6%
0
   0.0%
2
  14.3%
Male
5
  71.4%
7
 100.0%
12
  85.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 14 participants
Caucasian
5
  71.4%
5
  71.4%
10
  71.4%
Black/African American
0
   0.0%
2
  28.6%
2
  14.3%
Hispanic
1
  14.3%
0
   0.0%
1
   7.1%
Other
1
  14.3%
0
   0.0%
1
   7.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 7 participants 14 participants
7 7 14
1.Primary Outcome
Title Test of Adolescent Social Skills Knowledge (TASSK)
Hide Description 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.
Time Frame Baseline to 14-weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants who completed study questionnaire pre and post-treatment
Arm/Group Title Active Transcranial Direct Current Stimulation Sham Transcranial Direct Current Stimulation
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 3 6
Mean (Standard Deviation)
Unit of Measure: score on a scale
8  (2) 3.5  (2.1)
2.Primary Outcome
Title Social Responsiveness Scale (SRS)
Hide Description 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.
Time Frame Baseline to 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data for participants who completed all 14 weeks
Arm/Group Title Active Transcranial Direct Current Stimulation Sham Transcranial Direct Current Stimulation
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 4 6
Mean (Standard Deviation)
Unit of Measure: score on a scale
23.5  (18.2) 26.5  (22.6)
Time Frame 14 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active Transcranial Direct Current Stimulation Sham Transcranial Direct Current Stimulation
Hide Arm/Group Description

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

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

All-Cause Mortality
Active Transcranial Direct Current Stimulation Sham Transcranial Direct Current Stimulation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/7 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Active Transcranial Direct Current Stimulation Sham Transcranial Direct Current Stimulation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/7 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active Transcranial Direct Current Stimulation Sham Transcranial Direct Current Stimulation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/7 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Jane Joseph
Organization: Medical University of South Carolina
Phone: 843-792-7683
Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02998684     History of Changes
Other Study ID Numbers: Pro00056912
First Submitted: December 1, 2016
First Posted: December 20, 2016
Results First Submitted: July 25, 2018
Results First Posted: September 3, 2018
Last Update Posted: September 3, 2018