Cerebellar Transcranial Direct Current Stimulation (tDCS) in Children With

Status Recruiting

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Autism Spectrum Disorder
Autistic Disorder
Child Development Disorders, Pervasive

Clinical Trial Details

NCT number	NCT05691283
Study type	Interventional
Source	University of Texas Southwestern Medical Center
Contact	Amy Magallanes
Phone	214-648-5155
Email	Amy.Magallanes@UTSouthwestern.edu
Status	Recruiting
Phase	N/A
Start date	June 20, 2023
Completion date	June 30, 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05207956` - App for Strengthening Services In Specialized Therapeutic Support	N/A
Completed	`NCT03286621` - Development of Eye-tracking Based Markers for Autism in Young Children
Completed	`NCT02608333` - Efficiency of Early Intervention for Autism Spectrum Disorder	N/A
Recruiting	`NCT05935722` - Evaluation of a Home-based Parenting Support Program: Parenting Young Children	N/A
Active, not recruiting	`NCT06259539` - A YouTube Curriculum for Children With Autism and Obesity	N/A
Active, not recruiting	`NCT06303791` - Digital-based Psychosocial Intervention for Parents of Children With Neurodevelopmental Disorders	N/A
Enrolling by invitation	`NCT05017779` - A Hybrid Effectiveness-implementation Trial of a High School-based Executive Function Treatment for Autistic Youth	N/A
Completed	`NCT04772898` - Effectiveness of a 6-week Hippotherapy Program in Children With Autism Spectrum Disorder	N/A
Recruiting	`NCT04987541` - The Therapeutic Effect of TBS Stimulation on Emotion Regulation in Autism Spectrum Disorder	N/A
Completed	`NCT04308915` - Mobile-based Games for Cognitive Training in Children With Neurodevelopmental Disorders	N/A
Completed	`NCT06038435` - The Effect of Cognitive Orientation Approach on Daily Occupational Performance With Autism Spectrum Disorder	N/A
Terminated	`NCT04049981` - Investigation of Mechanisms of Action in Superpower Glass	Phase 1/Phase 2
Completed	`NCT03693313` - The Effect of CrossFit Kids on Social Skills in Children With Autism Spectrum Disorder (CrossFit KAMP)	N/A
Recruiting	`NCT04107064` - Achieving Steady Work Among Adults With Autism Through Specialized Employment Program	N/A
Recruiting	`NCT03812068` - Parent-mediated Developmental Behavioral Intervention	N/A
Completed	`NCT03206996` - Exposure Therapy for Auditory Sensitivity in Autism	N/A
Completed	`NCT02299700` - Study to Evaluate the Janssen Autism Knowledge Engine in Children and Adults With Autism Spectrum Disorder	N/A
Completed	`NCT03422016` - Electroretinogram in Autistic Spectrum Disorders
Active, not recruiting	`NCT03548779` - North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2	N/A
Recruiting	`NCT05114538` - Improving the Part C Early Intervention Service Delivery System for Children With ASD	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms