Cerebellar Transcranial Direct Current Stimulation (tDCS) in Children With Autism Spectrum Disorder: Raynor Cerebellum Project

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

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-20

Study Completion Date

2026-06-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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transcranial direct current stimulation (tDCS), then sham stimulation

Participants receives three weeks of 20-minute tDCS stimulation. After a washout period of 3 months, they then receive three weeks of sham stimulation

Group Type EXPERIMENTAL

trans cranial direct current stimulation (tDCS)

Intervention Type DEVICE

Three weeks of 20-minute tDCS stimulation

Sham

Intervention Type DEVICE

Three weeks of sham stimulation

Sham stimulation, then transcranial direct current stimulation (tDCS)

Participants receives three weeks of sham stimulation. After a washout period of 3 months, they then receive three weeks of 20-minute tDCS stimulation

Group Type EXPERIMENTAL

trans cranial direct current stimulation (tDCS)

Intervention Type DEVICE

Three weeks of 20-minute tDCS stimulation

Sham

Intervention Type DEVICE

Three weeks of sham stimulation

Interventions

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trans cranial direct current stimulation (tDCS)

Three weeks of 20-minute tDCS stimulation

Intervention Type DEVICE

Sham

Three weeks of sham stimulation

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

5 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No