Back to resultsLearning Enhancement Through Neurostimulation in Autism (LENS)
Primary Purpose
Autism
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Transcranial Direct Current Stimulation
Sham Transcranial Direct Current Stimulation
PEERS Social Skills Training
Sponsored by
About this trial
This is an interventional treatment trial for Autism focused on measuring Autism, Adolescent, Social skills
Eligibility Criteria
Inclusion Criteria:
- Autism Spectrum Disorder
Exclusion Criteria:
- Intellectual Disabilities (Full-scale IQ <70)
- Hx of seizures within the last one year
- Contraindications for fMRI, such as metal implants in the head
Sites / Locations
- Medical Univeristy of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Active Transcranial Direct Current Stimulation
Sham Transcranial Direct Current Stimulation
Arm Description
Participants will receive active Transcranial Direct Current Stimulation
Participants will receive sham Transcranial Direct Current Stimulation
Outcomes
Primary Outcome Measures
Test of Adolescent Social Skills Knowledge (TASSK)
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.
Social Responsiveness Scale (SRS)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02998684
First Posted
December 1, 2016
Last Updated
August 29, 2018
Sponsor
Medical University of South Carolina
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT02998684
Brief Title
Learning Enhancement Through Neurostimulation in Autism
Acronym
LENS
Official Title
Learning Enhancement Through Neurostimulation in Autism
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will examine whether brain stimulation paired with social skills learning can help teenage boys with autism learn how to make and keep friends. Brain stimulation can enhance learning in some people. This study involves enrolling in a 14-week training program where teenage boys with autism interact in small groups and learn social skills. During the 14-week program participants will receive active brain stimulation, or non-active stimulation (placebo). Before and after this training, MRI scans will be taken to see whether the training with active brain stimulation made a different in brain activation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism
Keywords
Autism, Adolescent, Social skills
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Transcranial Direct Current Stimulation
Arm Type
Active Comparator
Arm Description
Participants will receive active Transcranial Direct Current Stimulation
Arm Title
Sham Transcranial Direct Current Stimulation
Arm Type
Sham Comparator
Arm Description
Participants will receive sham Transcranial Direct Current Stimulation
Intervention Type
Device
Intervention Name(s)
Active Transcranial Direct Current Stimulation
Intervention Type
Device
Intervention Name(s)
Sham Transcranial Direct Current Stimulation
Intervention Type
Behavioral
Intervention Name(s)
PEERS Social Skills Training
Intervention Description
14 weekly social skills training sessions for all participants
Primary Outcome Measure Information:
Title
Test of Adolescent Social Skills Knowledge (TASSK)
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
Title
Social Responsiveness Scale (SRS)
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Autism Spectrum Disorder
Exclusion Criteria:
Intellectual Disabilities (Full-scale IQ <70)
Hx of seizures within the last one year
Contraindications for fMRI, such as metal implants in the head
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jane Joseph, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Univeristy of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Learning Enhancement Through Neurostimulation in Autism
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