Learning Enhancement Through Neurostimulation in Autism
LENS
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 1, 2016
CompletedFirst Posted
Study publicly available on registry
December 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedResults Posted
Study results publicly available
September 4, 2018
CompletedSeptember 4, 2018
August 1, 2018
1 year
December 1, 2016
July 25, 2018
August 29, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Baseline to 14-weeks
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.
Baseline to 14 weeks
Study Arms (2)
Active Transcranial Direct Current Stimulation
ACTIVE COMPARATORParticipants will receive active Transcranial Direct Current Stimulation
Sham Transcranial Direct Current Stimulation
SHAM COMPARATORParticipants will receive sham Transcranial Direct Current Stimulation
Interventions
14 weekly social skills training sessions for all participants
Eligibility Criteria
You may qualify if:
- Autism Spectrum Disorder
You may not qualify if:
- Intellectual Disabilities (Full-scale IQ \<70)
- Hx of seizures within the last one year
- Contraindications for fMRI, such as metal implants in the head
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical Univeristy of South Carolina
Charleston, South Carolina, 29425, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jane Joseph
- Organization
- Medical University of South Carolina
Study Officials
- PRINCIPAL INVESTIGATOR
Jane Joseph, PhD
Medical University of South Carolina
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2016
First Posted
December 20, 2016
Study Start
July 1, 2016
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
September 4, 2018
Results First Posted
September 4, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share