Cerebellar tDCS in Children With Autism Spectrum Disorder

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT04446442
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
4 Years - 17 Years
Healthy Volunteers
Accepted

Interventions

  • tDCS — DEVICE
    A current of 1 mA will be administered for 20 minutes of with either anodal or cathodal tDCS administration to the right crus I/II area of the cerebellum.

Study Details

The purpose of this research study is to investigate whether tDCS to the cerebellum (specifically, the right crus I/II area of the cerebellum) of children and young adults with autism spectrum disorders (ASD) is safe and to examine its effects on some of the symptoms of ASD, such as repetitive behaviors and hyperactivity.

Key Dates

Start date
Jun 4, 2019
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Full Administration of Transcranial Direct Current Stimulation
    Each subject will undergo psychosocial and behavioral assessments at a session prior to the administration of tDCS. The second session will include the tDCS Administration; a current of 1 mA will be administered over 20 minutes to the right crusI/II area of the cerebellum with a 15 second fade in period at the beginning and a 15 second fade out period at the end. During the tDCS administration, subjects will undergo functional MRI scanning. After the tDCS administration, subjects will repeat psychosocial and behavioral assessments.
  • Sham Comparator: Sham Administration of Transcranial Direct Current Stimulation
    Each subject will undergo psychosocial and behavioral assessments at a session prior to the administration of tDCS. The second session will include the tDCS Administration; a current of 1mA increased over 15 seconds and immediately decreased over 15 seconds to provide sensation associated with tDCS. During the sham administration, subjects will undergo functional MRI scanning. After the tDCS administration, subjects will repeat psychosocial and behavioral assessments.

Primary Outcome Measure

Incidence of tDCS associated side effects assessed by tDCS Safety Assessment [ Time Frame: Post-Intervention up to one month ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Children's Medical CenterDallasTexas75235-
University of Texas SouthwesternDallasTexas75390-

Find similar trials in Dallas, TX

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
Children's Medical Center· Dallas, TXUniversity of Texas Southwestern· Dallas, TX

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