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Trial record 2 of 258 for:    Recruiting, Not yet recruiting, Available Studies | "Autistic Disorder"

Motor Learning and Brain Changes in Autism

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ClinicalTrials.gov Identifier: NCT02358317
Recruitment Status : Recruiting
First Posted : February 6, 2015
Last Update Posted : October 17, 2018
Sponsor:
Collaborator:
Brain & Behavior Research Foundation
Information provided by (Responsible Party):
University of Wisconsin, Madison

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).

Condition or disease Intervention/treatment Phase
Autistic Disorder Behavioral: Video Game Motor Training Behavioral: Sedentary Video Game Training Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effects of Video Game Learning on the Brain in Adolescents With Autism: A Pilot Study
Actual Study Start Date : March 2015
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
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.
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.
Behavioral: Sedentary Video Game Training



Primary Outcome Measures :
  1. Balance Time [ Time Frame: 6 weeks ]
  2. Postural Stability [ Time Frame: 6 weeks ]
    Center of Pressure Measurements from Wii Balance Board

  3. White matter microstructure of the Corticospinal tract [ Time Frame: 6 weeks ]
    White matter microstructure of the Corticospinal tract, as measured through Diffusion Weighted Imaging


Secondary Outcome Measures :
  1. Adaptive Daily Living Skills [ Time Frame: 6 weeks ]
    Vineland-II and Waisman Adaptive Daily Living Skills Measurements

  2. Social Responsiveness [ Time Frame: 6 weeks ]
    Social Responsiveness Scale (SRS) Measurements



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02358317


Contacts
Contact: Brittany Travers, Ph.D. 608-263-0282 btravers@wisc.edu

Locations
United States, Wisconsin
Waisman Center, University of Wisconsin-Madison Recruiting
Madison, Wisconsin, United States, 53705
Contact: Brittany Travers, Ph.D.    608-263-0282    btravers@wisc.edu   
Sponsors and Collaborators
University of Wisconsin, Madison
Brain & Behavior Research Foundation
Investigators
Principal Investigator: Brittany G Travers, Ph.D. University of Wisconsin, Madison