Cerebellar Transcranial Direct Current Stimulation (tDCS) in Children With Autism Spectrum Disorder: Raynor Cerebellum Project
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: trans cranial direct current stimulation (tDCS), Sham.
- Who it may be relevant to
- Registry conditions: Autism Spectrum Disorder. Basic parameters: 5 years — 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Right Lateralized Posterior Cerebellar tDCS in Children With Autism Spectrum Disorder
Overview
The purpose of this research study is to investigate the effects of transcranial direct current stimulation (tDCS) on some of the challenges faced by children with Autism Spectrum Disorder (ASD).
Detailed description
The study will be randomized, double-blind, within subject crossover design. It will involve a group of 30-40 children and young adults with Autism Spectrum Disorder (ASD). We may recruit up to 60 subjects. Diagnosis of ASD will be confirmed with the Autism Diagnostic Interview-Revised (ADI-R) or Autism Diagnostic Observation Schedule-2 (ADOS-2) by a research-reliable clinician. Each participant will undergo a sham condition and a transcranial direct current stimulation (tDCS) condition, the order of sham and tDCS conditions will be randomly assigned to each participant during baseline testing. Sham refers to participants only receiving 1 milliamp of tDCS stimulation for 1 minute, and tDCS stimulation refers to 20 minutes of tDCS stimulation. The study involves an initial screening visit followed by two sessions with three months between each session period. Each session includes the following: pre-testing and imaging, tDCS 3-week session, post-testing and imaging. Participants will complete an initial screening to confirm clinical diagnosis of ASD, determine baseline cognitive functioning, and complete a practice Magnetic Resonance Imaging (MRI) and Magnetoencephalography (MEG) session. At pre-testing, they will complete a psychometric battery, as well as undergo safety screening, and an MRI and/or MEG. Each 3-week tDCS sessions will be randomized, and each participant will undergo three weeks of sham stimulation and three weeks of 20-minute tDCS stimulation. Neither the researchers nor the participants will know which group they are assigned during each three-week session.
Interventions
- Device trans cranial direct current stimulation (tDCS)
Three weeks of 20-minute tDCS stimulation - Device Sham
Three weeks of sham stimulation
Primary outcome measures
- Social behavior as measured by Reading the Mind in the Eyes (RME) Child Version [Time frame: Baseline]
- Social behavior as measured by Reading the Mind in the Eyes (RME) Child Version [Time frame: Post Treatment (approx at 3 month)]
- Social behavior as measured by Cyberball/Social Ball Throwing Task [Time frame: Baseline]
- Social behavior as measured by Cyberball/Social Ball Throwing Task [Time frame: Post Treatment (approx at 3 month)]
- Sensorimotor behavior as measured by Grip Strength [Time frame: Baseline]
- Sensorimotor behavior as measured by Grip Strength [Time frame: Post Treatment (approx at 3 month)]
- Sensorimotor behavior as measured by Reach Task [Time frame: Baseline]
- Sensorimotor behavior as measured by Reach Task [Time frame: Post Treatment (approx at 3 month)]
- Sensorimotor behavior as measured by Sensory Profile-2 [Time frame: Baseline]
- Sensorimotor behavior as measured by Sensory Profile-2 [Time frame: Post Treatment (approx at 3 month)]
Secondary outcome measures (6)
- Executive functioning as measured by Flanker Inhibitory Control and Attention [Time frame: Baseline]
- Executive functioning as measured by Flanker Inhibitory Control and Attention [Time frame: Post Treatment (approx at 3 month)]
- Executive functioning as measured by Dimensional Card Change Sort [Time frame: Baseline]
- Executive functioning as measured by Dimensional Card Change Sort [Time frame: Post Treatment (approx at 3 month)]
- Working memory as measured by Stanford Binet-V Working Memory Subtest [Time frame: Baseline]
- Working memory as measured by Stanford Binet-V Working Memory Subtest [Time frame: Post Treatment (approx at 3 month)]
Eligibility criteria
Inclusion criteria
- Ages 5 to 21, male and female, with known autism spectrum disorder as diagnosed by a clinician
Exclusion criteria
- Pregnancy
- Brain implants
- Pacemakers
- Any biomedical or metal implants in any part of body
- Hearing or visual impairment
- History of brain injury
- Known brain or skull abnormality other than those that may be associated with ASD
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- UT Southwestern Medical Center — Dalls
Identifiers
NCT: NCT05691283 · STU-2022-0689