60 Participants Needed

tDCS for Autism

Recruiting at 1 trial location
PT
AM
Overseen ByAmy Magallanes
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Texas Southwestern Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a treatment called tDCS, which uses a small electrical current applied to the brain. The study focuses on children and young adults with Autism Spectrum Disorders (ASD) to see if it can help reduce symptoms like repetitive behaviors and hyperactivity. The electrical current aims to improve brain function by enhancing communication between brain cells. tDCS has been proposed as a new intervention method in ASD with the potential to improve cognitive, motor, and social communication abilities.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is transcranial direct current stimulation (tDCS) safe for humans, including children with autism?

Research shows that tDCS is generally safe for humans, including children with autism and other neurodevelopmental disorders. Studies have found it to be well-tolerated with no serious adverse effects reported in over 33,200 sessions across various populations, including potentially vulnerable groups like children.12345

How is the treatment tDCS different from other treatments for autism?

Transcranial Direct Current Stimulation (tDCS) is unique because it uses a mild electrical current applied to the scalp to modulate brain activity, which is different from traditional drug treatments. It is non-invasive and focuses on improving motor and cognitive functions, potentially reducing autism symptoms without the use of medication.12678

What data supports the effectiveness of the treatment tDCS for autism?

Research shows that transcranial direct current stimulation (tDCS) can improve sociability, behavior, health, and physical conditions in children with autism, with significant decreases in autism treatment evaluation checklist scores compared to a control group.12679

Who Is on the Research Team?

PT

Peter Tsai, MD, PhD

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You can speak using simple and flexible sentences.
I am between 4 and 17 years old.
You need to have an IQ score above 70, which is the average score for most people.
See 1 more

Exclusion Criteria

You have a history of head injury.
You have metal or electronic devices implanted in your body, such as a pacemaker or brain implant.
I have brain abnormalities not related to autism.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit
1 visit (in-person)

Orientation and Baseline Assessment

Participants undergo orientation, safety screening, mock MRI, and baseline behavioral assessments

1 day
1 visit (in-person)

Treatment

Participants receive either sham or active tDCS treatment with fMRI scanning and post-treatment assessments

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up assessments at 1 week and 1 month

1 month
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • tDCS
Trial Overview 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.
How Is the Trial Designed?
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials
1,102
Recruited
1,077,000+

United States Department of Defense

Collaborator

Trials
940
Recruited
339,000+

Published Research Related to This Trial

Transcranial direct current stimulation (tDCS) significantly reduced autism severity in children with autism spectrum disorder (ASD) after both 5 and 20 sessions compared to a control group receiving sham treatment, with effects lasting for at least 12 months.
There was no significant difference in efficacy between the 5-session and 20-session tDCS groups, suggesting that fewer sessions may be just as effective as more, while sham tDCS also showed some benefits starting at 6 months.
Long-term effects of transcranial direct current stimulation in the treatment of autism spectrum disorder: A randomized controlled trial.Auvichayapat, P., Intayot, K., Udomchat, C., et al.[2023]
A systematic review of five studies on transcranial direct current stimulation (tDCS) in children with autism spectrum disorder (ASD) showed positive effects on reducing symptom severity, although the studies varied widely in design and sample size (1 to 20 participants).
Despite the encouraging preliminary evidence suggesting potential benefits, the overall quality of the studies is low, indicating a need for more rigorous randomized controlled trials to better understand the efficacy of tDCS in treating ASD.
Transcranial direct current stimulation in children with autism spectrum disorder: a systematic scoping review.Osório, AAC., Brunoni, AR.[2019]
Bilateral anodal transcranial direct current stimulation (tDCS) applied to the prefrontal and motor areas showed significant therapeutic effects in children with autism spectrum disorder (ASD), leading to improvements in sociability and behavioral health, as indicated by decreased scores on the autism treatment evaluation checklist (ATEC).
The study involved 50 children with ASD who underwent 10 sessions of tDCS, with no reported side effects, suggesting that tDCS is a safe and noninvasive method for potentially enhancing clinical outcomes in this population.
Therapeutic Effects of Bilateral Anodal Transcranial Direct Current Stimulation on Prefrontal and Motor Cortical Areas in Children with Autism Spectrum Disorders: A Pilot Study.Hadoush, H., Nazzal, M., Almasri, NA., et al.[2021]

Citations

Long-term effects of transcranial direct current stimulation in the treatment of autism spectrum disorder: A randomized controlled trial. [2023]
Transcranial direct current stimulation in children with autism spectrum disorder: a systematic scoping review. [2019]
Therapeutic Effects of Bilateral Anodal Transcranial Direct Current Stimulation on Prefrontal and Motor Cortical Areas in Children with Autism Spectrum Disorders: A Pilot Study. [2021]
Effect of anodal transcranial direct current stimulation on autism: a randomized double-blind crossover trial. [2018]
Transcranial direct current stimulation for hyperactivity and noncompliance in autistic disorder. [2019]
Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]
A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. [2018]
Transcranial Direct Current Stimulation in Child and Adolescent Psychiatric Disorders. [2019]
Transcranial Direct Current Stimulation Modulates EEG Microstates in Low-Functioning Autism: A Pilot Study. [2023]
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