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

The University of Texas System (UT)

Status: Enrolling

Conditions: Autism Spectrum Disorder

Treatments: Device: Sham; Device: trans cranial direct current stimulation (tDCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT05691283

STU-2022-0689

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 5 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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60 participants in 2 patient groups

transcranial direct current stimulation (tDCS), then sham stimulation

Experimental group

Description:

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

Treatment:

Device: trans cranial direct current stimulation (tDCS)

Device: Sham

Sham stimulation, then transcranial direct current stimulation (tDCS)

Experimental group

Description:

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

Treatment:

Device: trans cranial direct current stimulation (tDCS)

Device: Sham