tDCS for Autism

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Peter Tsai, MD, PhD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Epilepsy, Brain injury, Implants, others

No Placebo Group

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{2 5 6 7 8}

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. ^{1 2 4 5 9}

Research Team

Peter Tsai, MD, PhD

Principal Investigator

University of Texas Southwestern Medical Center

Eligibility Criteria

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.

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.

Trial Timeline

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)

Treatment Details

Interventions

• tDCS (Noninvasive Brain Stimulation)

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.

Participant Groups

Group I: Full Administration of Transcranial Direct Current Stimulation Experimental Treatment 1 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 Stimulation Placebo Group 1 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.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Daniel K. Podolsky

University of Texas Southwestern Medical Center

Chief Executive Officer since 2008

MD from Harvard Medical School

Robert L. Bass

University of Texas Southwestern Medical Center

Chief Medical Officer since 2019

MD from University of Texas Southwestern Medical School

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Pete Hegseth

United States Department of Defense

Chief Executive Officer

Bachelor's degree in Political Science from Princeton University, JD from Harvard Law School

Lisa Hershman

United States Department of Defense

Chief Medical Officer since 2021

MD from Uniformed Services University of the Health Sciences

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study involving 20 patients with autism, anodal transcranial direct current stimulation (tDCS) significantly reduced scores on the Childhood Autism Rating Scale (CARS) and the Autism Treatment Evaluation Checklist (ATEC), indicating improvements in autism symptoms.

Additionally, the Children's Global Assessment Scale (CGAS) showed a significant increase at 7 days post-treatment, suggesting that tDCS may enhance overall functioning in individuals with autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of anodal transcranial direct current stimulation on autism: a randomized double-blind crossover trial. Amatachaya, A., Auvichayapat, N., Patjanasoontorn, N., et al.[2018]

In a study involving 12 young adults with autism, inhibitory transcranial direct current stimulation (tDCS) led to a significant average reduction of 26.7% in abnormal behaviors as measured by the Aberrant Behavior Checklist after 10 sessions.

The most notable improvement was in hyperactivity and non-compliance, which decreased by 35.9%, and importantly, no adverse effects were reported, suggesting tDCS is a safe and feasible treatment option for behavioral abnormalities in autistic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation for hyperactivity and noncompliance in autistic disorder. D'Urso, G., Bruzzese, D., Ferrucci, R., et al.[2019]

Transcranial Direct Current Stimulation (tDCS) has been shown to be safe, with no reports of Serious Adverse Effects or irreversible injuries across over 33,200 sessions involving more than 1,000 subjects, including vulnerable populations.

Safety assessments indicate that the current densities used in conventional tDCS (≤4 milliamperes) are significantly lower than those that could potentially cause brain injury, suggesting that tDCS protocols are well within safe limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Bikson, M., Grossman, P., Thomas, C., et al.[2022]

A systematic review of 64 studies involving 2262 participants found that transcranial direct current stimulation (tDCS) has a low dropout rate (6% for active and 7.2% for sham), indicating good acceptability among participants.

Despite the low dropout rates, many studies inadequately reported adverse events (AEs), highlighting a need for improved guidelines to standardize AE reporting in tDCS research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. Aparício, LVM., Guarienti, F., Razza, LB., et al.[2018]

Transcranial direct current stimulation (tDCS) has been found to be safe and well-tolerated in children and adolescents with neurodevelopmental disorders, such as ADHD and autism, based on early short-term studies.

Preliminary evidence suggests that tDCS may help reduce symptoms and improve cognitive function in these youth, but more extensive research is needed to understand its effects on the developing brain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation in Child and Adolescent Psychiatric Disorders. Lee, JC., Kenney-Jung, DL., Blacker, CJ., et al.[2019]

Transcranial direct current stimulation (tDCS) showed significant changes in EEG microstates and Autism Behavior Checklist (ABC) scores in children with autism spectrum disorder (ASD), suggesting it may positively affect neurodevelopmental functions.

In contrast, the sham stimulation group did not exhibit any changes in EEG microstates or ABC scores, highlighting the potential efficacy of tDCS as a treatment for ASD compared to a placebo effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation Modulates EEG Microstates in Low-Functioning Autism: A Pilot Study. Kang, J., Fan, X., Zhong, Y., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Long-term effects of transcranial direct current stimulation in the treatment of autism spectrum disorder: A randomized controlled trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation in children with autism spectrum disorder: a systematic scoping review. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

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]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of anodal transcranial direct current stimulation on autism: a randomized double-blind crossover trial. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation for hyperactivity and noncompliance in autistic disorder. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation in Child and Adolescent Psychiatric Disorders. [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation Modulates EEG Microstates in Low-Functioning Autism: A Pilot Study. [2023]