Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 8 of 24 for:    Developmental Disabilities | ( Map: South Carolina, United States )

Learning Enhancement Through Neurostimulation in Autism (LENS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02998684
Recruitment Status : Completed
First Posted : December 20, 2016
Results First Posted : September 3, 2018
Last Update Posted : September 3, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Autism Device: Active Transcranial Direct Current Stimulation Device: Sham Transcranial Direct Current Stimulation Behavioral: PEERS Social Skills Training Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Learning Enhancement Through Neurostimulation in Autism
Study Start Date : July 2016
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Arm Intervention/treatment
Active Comparator: Active Transcranial Direct Current Stimulation
Participants will receive active Transcranial Direct Current Stimulation
Device: Active Transcranial Direct Current Stimulation
Behavioral: PEERS Social Skills Training
14 weekly social skills training sessions for all participants

Sham Comparator: Sham Transcranial Direct Current Stimulation
Participants will receive sham Transcranial Direct Current Stimulation
Device: Sham Transcranial Direct Current Stimulation
Behavioral: PEERS Social Skills Training
14 weekly social skills training sessions for all participants




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02998684


Locations
Layout table for location information
United States, South Carolina
Medical Univeristy of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Layout table for investigator information
Principal Investigator: Jane Joseph, PhD Medical University of South Carolina
  Study Documents (Full-Text)

Documents provided by Medical University of South Carolina:

Layout table for additonal information
Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02998684     History of Changes
Other Study ID Numbers: Pro00056912
First Posted: December 20, 2016    Key Record Dates
Results First Posted: September 3, 2018
Last Update Posted: September 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Medical University of South Carolina:
Autism
Adolescent
Social skills

Additional relevant MeSH terms:
Layout table for MeSH terms
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders