Motor Learning and Brain Changes in Autism

NCT ID: NCT02358317

Last Updated: 2019-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2019-05-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Autistic Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Video Game Motor Training

Intervention Type BEHAVIORAL

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.

Group Type ACTIVE_COMPARATOR

Sedentary Video Game Training

Intervention Type BEHAVIORAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Video Game Motor Training

Intervention Type BEHAVIORAL

Sedentary Video Game Training

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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
Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Brain & Behavior Research Foundation

OTHER

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Brittany G Travers, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Waisman Center, University of Wisconsin-Madison

Madison, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 23132272 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19025904 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22432902 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22484410 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2014-1499

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cognitive Control and Metacognition Training
NCT06885684 NOT_YET_RECRUITING NA