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Noninvasive Brain Stimulation

tDCS for Autism

N/A
Recruiting
Led By Peter Tsai, MD, PhD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
4-17 years old
Diagnosed with ASD and ADOS-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-intervention up to one month
Awards & highlights

Study Summary

This trial will investigate whether tDCS to the cerebellum is safe and effective in treating symptoms of ASD such as repetitive behaviors and hyperactivity.

Who is the study for?
This trial is for children and young adults aged 4-17 with Autism Spectrum Disorder (ASD). Participants must have an IQ score of at least 70 and be able to speak in simple sentences. It's not open to those with brain injuries, implants, pacemakers, hearing or visual impairments, epilepsy, or other brain abnormalities.Check my eligibility
What is being tested?
The study is testing the safety and impact of tDCS—a non-invasive brain stimulation technique—on the cerebellum area of kids with ASD. The focus is on whether it can reduce repetitive behaviors and hyperactivity associated with ASD.See study design
What are the potential side effects?
Potential side effects from tDCS may include discomfort at the site of stimulation, headache, fatigue, nausea or itching under the electrode. Serious side effects are rare but could involve seizures or mood changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 4 and 17 years old.
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I have been diagnosed with Autism Spectrum Disorder (ASD).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-intervention at 1 week and post-intervention at 1 hour
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-intervention at 1 week and post-intervention at 1 hour for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of tDCS associated side effects assessed by tDCS Safety Assessment
Secondary outcome measures
Change in Autism Spectrum Disorder Symptoms assessed by Autism Spectrum Rating Scale
Change in Autism Spectrum Disorder Symptoms assessed by Cyberball/Social Ball Throwing Task
Change in Autism Spectrum Disorder Symptoms assessed by Dimensional Change Card Sort
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Full Administration of Transcranial Direct Current StimulationExperimental Treatment1 Intervention
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.
Group II: Sham Administration of Transcranial Direct Current StimulationPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
tDCS
2017
Completed Phase 2
~640

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,047 Previous Clinical Trials
1,053,739 Total Patients Enrolled
1 Trials studying Autism Spectrum Disorder
60 Patients Enrolled for Autism Spectrum Disorder
United States Department of DefenseFED
861 Previous Clinical Trials
227,134 Total Patients Enrolled
18 Trials studying Autism Spectrum Disorder
1,680 Patients Enrolled for Autism Spectrum Disorder
Peter Tsai, MD, PhDPrincipal Investigator - University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
1 Previous Clinical Trials
60 Total Patients Enrolled
1 Trials studying Autism Spectrum Disorder
60 Patients Enrolled for Autism Spectrum Disorder

Media Library

tDCS (Noninvasive Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04446442 — N/A
Autism Spectrum Disorder Research Study Groups: Sham Administration of Transcranial Direct Current Stimulation, Full Administration of Transcranial Direct Current Stimulation
Autism Spectrum Disorder Clinical Trial 2023: tDCS Highlights & Side Effects. Trial Name: NCT04446442 — N/A
tDCS (Noninvasive Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04446442 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age criterion for this trial limited to those aged over 60 years old?

"This research initiative is recruiting individuals between the ages of 4 and 17."

Answered by AI

What is the scale of participation in this research endeavor?

"Affirmative. According to the data posted on clinicaltrials.gov, this active medical study is currently seeking patients. It was initially posted on June 4th 2019 and last modified November 30 2021 - with room for 60 participants at 2 distinct sites."

Answered by AI

Is there still capacity to enroll participants in this scientific experiment?

"Affirmative. In accordance with clinicaltrials.gov, this medical trial is in the process of recruiting participants. Initially posted on June 4th 2019 and updated most recently on November 30th 2021, 60 research subjects are being sought out at two distinct centres."

Answered by AI

Am I eligible to join this experiment?

"This research study is looking to enrol 60 individuals with autism spectrum disorder of ages 4-17. To be eligible, applicants need an IQ no lower than 70 (1.5 Standard Deviations below the mean), and must possess the ability to construct flexible, spontaneous sentences at a minimum level."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Florida
Other
Pennsylvania
How old are they?
18 - 65
< 18
What site did they apply to?
Children's Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
Cerebellar tDCS in Children With Autism Spectrum Disorder
Peter Tsai 2019. "Cerebellar tDCS in Children With Autism Spectrum Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04446442.
All > Asd > Autism
~7 spots leftby Dec 2024
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