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OpenTrials
Completed

NCT Number: NCT02998684

Learning Enhancement Through Neurostimulation in Autism

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.

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Key information

Conditions

Autism Autism Spectrum Disorder Autistic Disorder Behavior Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders Social Behavior Social Skills

Age range

14 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Univeristy of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Transcranial Direct Current Stimulation

Device

Sham Transcranial Direct Current Stimulation

Device

PEERS Social Skills Training

Behavioral

14 weekly social skills training sessions for all participants

Primary outcomes

  1. Test of Adolescent Social Skills Knowledge (TASSK)

    Time frame: 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.

  2. Social Responsiveness Scale (SRS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Acronym: LENS

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 20, 2016
Registry last updated
Sep 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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