Clinical trial NCT05691283: Cerebellar Transcranial Direct Current Stimulation (tDCS) in Children with Autism Spectrum Disorder: Raynor Cerebellum Project
Official title: Right Lateralized Posterior Cerebellar TDCS in Children with Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Children
Young adults
Autism Spectrum Disorder
Transcranial direct current stimulation
tDCS
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Social behavior as measured by Reading the Mind in the Eyes (RME) Child Version
timeFrame: Baseline
measure: Social behavior as measured by Reading the Mind in the Eyes (RME) Child Version
timeFrame: Post Treatment (approx at 3 month)
measure: Social behavior as measured by Cyberball/Social Ball Throwing Task
timeFrame: Baseline
measure: Social behavior as measured by Cyberball/Social Ball Throwing Task
timeFrame: Post Treatment (approx at 3 month)
measure: Sensorimotor behavior as measured by Grip Strength
timeFrame: Baseline
measure: Sensorimotor behavior as measured by Grip Strength
timeFrame: Post Treatment (approx at 3 month)
measure: Sensorimotor behavior as measured by Reach Task
timeFrame: Baseline
measure: Sensorimotor behavior as measured by Reach Task
timeFrame: Post Treatment (approx at 3 month)
measure: Sensorimotor behavior as measured by Sensory Profile-2
timeFrame: Baseline
measure: Sensorimotor behavior as measured by Sensory Profile-2
timeFrame: Post Treatment (approx at 3 month)
measure: Neurophysiological impacts as measured by Magnetoencephalography (MEG)
timeFrame: Baseline
measure: Neurophysiological impacts as measured by Magnetoencephalography (MEG)
timeFrame: Post Treatment (approx at 3 month)
measure: Neurophysiological impacts as measured by functional magnetic resonance imaging (fMRI)
timeFrame: Baseline
measure: Neurophysiological impacts as measured by functional magnetic resonance imaging (fMRI)
timeFrame: Post Treatment (approx at 3 month)
Secondary outcomes:
measure: Executive functioning as measured by Flanker Inhibitory Control and Attention
timeFrame: Baseline
measure: Executive functioning as measured by Flanker Inhibitory Control and Attention
timeFrame: Post Treatment (approx at 3 month)
measure: Executive functioning as measured by Dimensional Card Change Sort
timeFrame: Baseline
measure: Executive functioning as measured by Dimensional Card Change Sort
timeFrame: Post Treatment (approx at 3 month)
measure: Working memory as measured by Stanford Binet-V Working Memory Subtest
timeFrame: Baseline
measure: Working memory as measured by Stanford Binet-V Working Memory Subtest
timeFrame: Post Treatment (approx at 3 month)
Other outcomes:
Locations:
city: Dalls
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Peter Tsai, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: