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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02358317
Other study ID # 2014-1499
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2015
Est. completion date May 24, 2019

Study information

Verified date June 2019
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date May 24, 2019
Est. primary completion date May 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 13 Years to 17 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Video Game Motor Training

Sedentary Video Game Training


Locations

Country Name City State
United States Waisman Center, University of Wisconsin-Madison Madison Wisconsin

Sponsors (2)

Lead Sponsor Collaborator
University of Wisconsin, Madison Brain & Behavior Research Foundation

Country where clinical trial is conducted

United States, 

References & Publications (4)

Alexander AL, Hurley SA, Samsonov AA, Adluru N, Hosseinbor AP, Mossahebi P, Tromp do PM, Zakszewski E, Field AS. Characterization of cerebral white matter properties using quantitative magnetic resonance imaging stains. Brain Connect. 2011;1(6):423-46. doi: 10.1089/brain.2011.0071. Epub 2012 Jan 27. Review. — View Citation

Deoni SC, Rutt BK, Arun T, Pierpaoli C, Jones DK. Gleaning multicomponent T1 and T2 information from steady-state imaging data. Magn Reson Med. 2008 Dec;60(6):1372-87. doi: 10.1002/mrm.21704. — View Citation

Travers BG, Powell PS, Klinger LG, Klinger MR. Motor difficulties in autism spectrum disorder: linking symptom severity and postural stability. J Autism Dev Disord. 2013 Jul;43(7):1568-83. doi: 10.1007/s10803-012-1702-x. — View Citation

Zhang H, Schneider T, Wheeler-Kingshott CA, Alexander DC. NODDI: practical in vivo neurite orientation dispersion and density imaging of the human brain. Neuroimage. 2012 Jul 16;61(4):1000-16. doi: 10.1016/j.neuroimage.2012.03.072. Epub 2012 Mar 30. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Balance Time 6 weeks
Primary Postural Stability Center of Pressure Measurements from Wii Balance Board 6 weeks
Primary White matter microstructure of the Corticospinal tract White matter microstructure of the Corticospinal tract, as measured through Diffusion Weighted Imaging 6 weeks
Secondary Adaptive Daily Living Skills Vineland-II and Waisman Adaptive Daily Living Skills Measurements 6 weeks
Secondary Social Responsiveness Social Responsiveness Scale (SRS) Measurements 6 weeks
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