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Autistic DisorderNCT02358317

Motor Learning and Brain Changes in Autism

A study testing Video Game Motor Training and Sedentary Video Game Training in people with Autistic Disorder, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 13 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Autistic Disorder
What is being tested?
Video Game Motor Training and Sedentary Video Game Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteUnited States
Study dates
Mar 2015to 24 May 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Waisman Center, University of Wisconsin-Madison

    Madison, Wisconsin, 53705

Other trials in United States

About this study

Official title: The Effects of Video Game Learning on the Brain in Adolescents With Autism: A Pilot Study

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).

Read the 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.

Being tested
Video Game Motor Training, Sedentary Video Game Training
Keywords
Autism, Postural Stability, Exergaming, White Matter
Medical subject headings
Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Video Game Motor TrainingBehavioural

  • Sedentary Video Game TrainingBehavioural

Study groups in NCT02358317
Study groupRoleWhat they receive
Video Game Motor TrainingExperimentalParticipants 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.
Receives: Behavioral: Video Game Motor Training
Sedentary Video Game TrainingActive comparatorParticipants 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.
Receives: Behavioral: Sedentary Video Game Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Balance Time

    Measured: 6 weeks

  2. Postural Stability

    Center of Pressure Measurements from Wii Balance Board

    Measured: 6 weeks

  3. White matter microstructure of the Corticospinal tract

    White matter microstructure of the Corticospinal tract, as measured through Diffusion Weighted Imaging

    Measured: 6 weeks

Secondary outcomes (2)

  1. Adaptive Daily Living Skills

    Vineland-II and Waisman Adaptive Daily Living Skills Measurements

    Measured: 6 weeks

  2. Social Responsiveness

    Social Responsiveness Scale (SRS) Measurements

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionMay 2019
  4. Study completion24 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02358317
Sponsor's protocol ID
2014-1499
Status last verified
Jun 2019
First submitted
3 Feb 2015
Last updated
11 Jun 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 23132272

  • 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.

    PubMed 19025904

  • 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.

    PubMed 22432902

  • 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.

    PubMed 22484410

Questions about this trial

What is this clinical trial studying?

A study testing Video Game Motor Training and Sedentary Video Game Training in people with Autistic Disorder, run by University of Wisconsin, Madison at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Balance Time (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02358317, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2019.

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