tDCS for Autism

Recruiting at 1 trial location

Overseen By Amy Magallanes

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Epilepsy, Brain injury, Implants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 day

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Transcranial Direct Current Stimulation (tDCS) might help manage symptoms of autism spectrum disorders (ASD), such as repetitive behaviors and hyperactivity. The study examines the safety of this treatment when applied to the cerebellum. Participants will receive either the actual tDCS treatment or a sham (fake) version to compare effects. Children and young adults aged 4-17, diagnosed with ASD and able to speak in simple sentences, may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research in ASD treatment.

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 prior data suggests that this tDCS technique is safe for children and young adults with autism?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe for children with autism. Studies have found that children can undergo several weeks of tDCS treatment without serious side effects. For example, one study observed improvements in social skills and reported no major problems during the sessions.

In over 18,000 sessions of low-intensity tDCS, guidelines have reported no serious issues, suggesting the treatment is safe for most people. While minor effects like scalp tingling might occur, serious risks are rare.

Overall, existing research suggests that tDCS is safe for children and young adults with autism, with few negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using transcranial direct current stimulation (tDCS) for autism because it offers a non-invasive approach that targets brain activity directly. Unlike traditional treatments for autism, which often rely on behavioral therapy and medications with various side effects, tDCS delivers a mild electrical current to specific areas of the brain, potentially improving social and behavioral functions without the need for drugs. This method also allows for real-time brain monitoring through MRI, providing insights into how the brain responds during treatment, which could lead to more personalized and effective interventions.

What evidence suggests that tDCS might be an effective treatment for autism?

Research has shown that transcranial direct current stimulation (tDCS) might reduce the severity of autism over time. In this trial, participants will join different treatment arms to evaluate tDCS's effects. Studies have found that children with autism who received tDCS showed noticeable improvements in communication and emotional management. They also demonstrated better thinking and understanding skills. Additionally, tDCS appears to enhance social interactions and brain function by balancing brain activity. While more research is needed, these findings suggest that tDCS could be a promising treatment for some autism symptoms. ^{1 4 6 7 8}

Who Is on the Research Team?

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.

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.

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?

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+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

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]

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) 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]

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]

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]

Citations

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Results: The 5-tDCS and 20-tDCS groups evidenced greater reductions in autism severity than the control group at days 5 and 14, and months 6 and ...

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nature.com

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HD-tDCS effects on social impairment in autism spectrum ...

HD-tDCS effectively improved social impairment symptoms in children with ASD, particularly those with typical sensory integration and either typical or hypo- ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0891422225000423

Assessing the impact of Transcranial Direct Current ...

The results demonstrated significant improvements in social communication, emotional regulation, and cognitive outcomes among children with autism spectrum ...

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jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2833028

Transcranial Pulsed Current Stimulation and Social ...

Treatment results demonstrated significantly improved social functioning compared with sham stimulation and no association of tPCS with serious ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11939205/

Transcranial Direct Current Stimulation Can Modulate Brain ...

These findings suggest that tDCS may improve brain function in children with ASD by regulating brain complexity and effective connectivity, ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8245257/

Transcranial Direct Current Stimulation (tDCS) over the Left ...

We found that children with ASD can tolerate three-week tDCS treatment with no serious adverse events detected. A within-group comparison showed ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT01603225

Transcranial Direct Current Stimulation and Autism

This research is being done to determine whether transcranial direct current stimulation (tDCS) can improve certain mental abilities.

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8435587/

Repeated Sessions of Transcranial Direct Current Stimulation ...

As for potential risks of tDCS, guidelines report no serious adverse events in over 18,000 sessions of low-intensity transcranial electrical ...