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Motor Learning and Brain Changes in Autism

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ClinicalTrials.gov Identifier: NCT02358317
Recruitment Status : Completed
First Posted : February 6, 2015
Last Update Posted : June 11, 2019
Sponsor:
Collaborator:
Brain & Behavior Research Foundation
Information provided by (Responsible Party):
University of Wisconsin, Madison

Tracking Information
First Submitted Date  ICMJE February 3, 2015
First Posted Date  ICMJE February 6, 2015
Last Update Posted Date June 11, 2019
Actual Study Start Date  ICMJE March 2015
Actual Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2015)
  • Balance Time [ Time Frame: 6 weeks ]
  • Postural Stability [ Time Frame: 6 weeks ]
    Center of Pressure Measurements from Wii Balance Board
  • White matter microstructure of the Corticospinal tract [ Time Frame: 6 weeks ]
    White matter microstructure of the Corticospinal tract, as measured through Diffusion Weighted Imaging
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2015)
  • Adaptive Daily Living Skills [ Time Frame: 6 weeks ]
    Vineland-II and Waisman Adaptive Daily Living Skills Measurements
  • Social Responsiveness [ Time Frame: 6 weeks ]
    Social Responsiveness Scale (SRS) Measurements
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Motor Learning and Brain Changes in Autism
Official Title  ICMJE The Effects of Video Game Learning on the Brain in Adolescents With Autism: A Pilot Study
Brief Summary The purpose of this pilot study is to determine whether a video-game based motor training can affect postural stability, daily living skills, autism symptoms, and white matter microstructure of the corticospinal tract in adolescents with Autism Spectrum Disorder (ASD).
Detailed Description

Participants: Participants will include 30 adolescents with ASD (13-17 years of age) and 30 adolescents with typical development. Exclusion criteria consists of engaging in more than 2 hours/week of balance training activities (i.e., yoga, tai chi, Wii/Kinect balance games) at study start. Each individual will receive a pre-training magnetic resonance imaging (MRI) scan. Participants will be randomly assigned to either a treatment group or control group. Over the next six weeks, participants in the treatment group will come to the lab to complete 3-5 hours/week of video-game motor training. Participants in the passive control group will come to the lab to do basic motor measurements and sedentary video gaming without motor training. Participants will be asked not to start any new exercise-related programs during those 6 weeks. After the sixth week, all participants will complete a post-training MRI scan and behavioral assessment.

Motor Video Game Training: Participants in the treatment group will come to the University of Wisconsin lab to train 3-5 days each week under research staff supervision. Each training session will last 30-60 minutes and will begin and end with ~5 minutes playing the Ninja Training game from Dr. Ellertson's lab (Boise State University). In this game, participants will hold a position (i.e., the Karate Kid crane pose) for as long as they can, while we collect time-series data on the position of each joint using the Kinect camera as well as time-series data on the center of pressure using the Wii balance board. Participants are rewarded for holding the pose as long as possible by seeing the background behind them come to life. For the rest of the training, participants will play balance games from the Wii Fit.

Motor & Symptom Severity Assessments: Pre-post postural stability measures will be assessed in both groups through standing postures on the Wii balance board (as in Travers et al., 2013). Pre-post symptom severity measures will include parent-report measures of social function, repetitive behaviors/restricted interests, and measures of daily living skills.

Imaging Protocol: Pre- and post-training brain imaging will be completed using a 3 Tesla (ET) MRI scanner with a Nova 32-Channel Head Coil. All scanning will be performed in <60 minutes. Pulse sequences and protocols include advanced diffusion weighted imaging (DWI) with NODDI (Zhang et al., 2012) and multicomponent T1 and T2 relaxometry using steady state sequences (mcDESPOT; Deoni et al., 2008; Alexander et al., 2011). Structural imaging of anatomical detail for morphometric analyses will also be performed using a custom MP2RAGE sequence, which inherently removes the intensity variations from inhomogeneities in the coil sensitivities.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Autistic Disorder
Intervention  ICMJE
  • Behavioral: Video Game Motor Training
  • Behavioral: Sedentary Video Game Training
Study Arms  ICMJE
  • Experimental: Video Game Motor Training
    Participants in the treatment group will come to the University of Wisconsin lab for six weeks to train 3-5 days each week under research staff supervision. Each training session will last 30-60 minutes and will include playing our in-house Ninja Training game combined with balance games from the Wii Fit.
    Intervention: Behavioral: Video Game Motor Training
  • Active Comparator: Sedentary Video Game Training
    Participants randomly assigned to this condition will come to the lab for six weeks to play sedentary video games 3-5 days each week under research staff supervision. Each training session will last 30-60 minutes. Pre-and post assessments will be done identically to the Experimental group.
    Intervention: Behavioral: Sedentary Video Game Training
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 10, 2019)
62
Original Estimated Enrollment  ICMJE
 (submitted: February 3, 2015)
30
Actual Study Completion Date  ICMJE May 24, 2019
Actual Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria for ASD group:

  • Previous diagnosis of Autism Spectrum Disorder (ASD)
  • Meet criteria for ASD on the Autism Diagnostic Observation Scale (ADOS) and Social Communication Questionnaire (SCQ).

Exclusion Criteria:

  • Co-occuring tuberous sclerosis, fragile X, a history of severe head injury, intellectual disability (IQ<70), or hypoxia-ischemia.
  • Participants will not be able to be already engaged in more than 2 hours/week of balance training activities (i.e., yoga, tai chi, Wii/Kinect balance games) at study start
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02358317
Other Study ID Numbers  ICMJE 2014-1499
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE Brain & Behavior Research Foundation
Investigators  ICMJE
Principal Investigator: Brittany G Travers, Ph.D. University of Wisconsin, Madison
PRS Account University of Wisconsin, Madison
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP