Learning Enhancement Through Neurostimulation in Autism

Autism Clinical Trial

— LENS  

Official title:

Learning Enhancement Through Neurostimulation in Autism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02998684
• Other study ID #: Pro00056912
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: July 2017

Study information

• Verified date: August 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

Intervention

Device:
• Active Transcranial Direct Current Stimulation

• Sham Transcranial Direct Current Stimulation

Behavioral:
• PEERS Social Skills Training
14 weekly social skills training sessions for all participants

Locations

Country	Name	City	State
United States	Medical Univeristy of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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