Learning Enhancement Through Neurostimulation in Autism

Not Applicable

Completed

• Conditions: Autism
• Interventions: Device: Sham Transcranial Direct Current Stimulation; Device: Active Transcranial Direct Current Stimulation; Behavioral: PEERS Social Skills Training

• Registration Number: NCT02998684
• Lead Sponsor: Medical University of South Carolina

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-12-01
• Study First Submitted QC: 2016-12-16
• Study First Posted: 2016-12-20
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Results First Submitted: 2018-07-25
• Status Verified: 2018-08
• Results First Submitted QC: 2018-08-29
• Last Update Submitted: 2018-08-29
• Results First Posted: 2018-09-04
• Last Update Posted: 2018-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Autism Spectrum Disorder

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Transcranial Direct Current Stimulation	Sham Transcranial Direct Current Stimulation	Participants will receive sham Transcranial Direct Current Stimulation
Active Transcranial Direct Current Stimulation	Active Transcranial Direct Current Stimulation	Participants will receive active Transcranial Direct Current Stimulation
Active Transcranial Direct Current Stimulation	PEERS Social Skills Training	Participants will receive active Transcranial Direct Current Stimulation
Sham Transcranial Direct Current Stimulation	PEERS Social Skills Training	Participants will receive sham Transcranial Direct Current Stimulation

Primary Outcome Measures

Name	Time	Method
Test of Adolescent Social Skills Knowledge (TASSK)	Baseline to 14-weeks	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)	Baseline to 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.

Trial Locations

Locations (1)

Medical Univeristy of South Carolina; 🇺🇸 Charleston, South Carolina, United States