tDCS for Autism

Recruiting at 1 trial location

Overseen By Haley Walker

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Pregnancy, Brain implants, Pacemakers, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks (plus 3-month washout)

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) can assist children with Autism Spectrum Disorder (ASD). tDCS is a non-invasive procedure that applies a mild electrical current to the scalp to determine if it can improve symptoms. Participants will experience both the real and a placebo version of the treatment, with a break in between, to compare effects. Children and young adults aged 5 to 21 with a clinician-diagnosed ASD are eligible, unless they have conditions such as brain implants or past brain injuries. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance treatment options for ASD.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that transcranial direct current stimulation (tDCS) is safe for children with Autism Spectrum Disorder (ASD)?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe for children with Autism Spectrum Disorder (ASD). Studies have found that children can undergo a three-week course of tDCS without serious side effects. In one study, children responded well to tDCS, with no reports of severe side effects. This suggests that tDCS is a safe option for children with ASD, at least in the short term. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcranial direct current stimulation (tDCS) for autism because it offers a non-invasive way to potentially ease symptoms. Unlike traditional treatments like behavioral therapy or medication, tDCS works by gently stimulating specific areas of the brain with a low electrical current, which may improve neural connections and brain function. This innovative method could provide a new avenue for enhancing communication and social skills in individuals with autism, offering hope for those seeking alternatives to existing therapies.

What evidence suggests that transcranial direct current stimulation (tDCS) might be an effective treatment for Autism Spectrum Disorder (ASD)?

Research has shown that transcranial direct current stimulation (tDCS) can assist children with Autism Spectrum Disorder (ASD). Studies have found improvements in communication and emotional management. One study found that tDCS helped with social challenges, particularly in children who typically process sensory information well. Positive effects on thinking skills were also noted. In this trial, participants will receive both tDCS and sham stimulation in different sequences to evaluate the effectiveness of tDCS in addressing some difficulties faced by children with ASD. ^{1 4 6 7 8}

Who Is on the Research Team?

Peter Tsai, MD, PhD

Principal Investigator

UT Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for children and young adults aged 5 to 21 with a clinical diagnosis of Autism Spectrum Disorder (ASD). It's not suitable for those who are pregnant, have brain implants or pacemakers, any metal implants, hearing or visual impairments, a history of brain injury, or known brain/skull abnormalities unrelated to ASD.

Inclusion Criteria

I am between 5 and 21 years old and have been diagnosed with autism.

Exclusion Criteria

Any biomedical or metal implants in any part of the body

I have no brain or skull issues unrelated to ASD.

History of brain injury

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Testing

Participants undergo baseline testing including psychometric battery, safety screening, and MRI/MEG

1 week

1 visit (in-person)

Treatment

Participants receive three weeks of sham stimulation and three weeks of 20-minute tDCS stimulation, with a 3-month washout period between sessions

6 weeks (plus 3-month washout)

Multiple visits (in-person)

Post-Testing

Participants undergo post-testing including psychometric battery and imaging

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sham
• Transcranial Direct Current Stimulation (tDCS)

Trial Overview The study is examining the impact of transcranial direct current stimulation (tDCS) on challenges associated with ASD. Participants will receive either the actual tDCS treatment or a sham (placebo-like) procedure to compare effects.

How Is the Trial Designed?

Group I: transcranial direct current stimulation (tDCS), then sham stimulation Experimental Treatment 2 Interventions

Participants receives three weeks of 20-minute tDCS stimulation. After a washout period of 3 months, they then receive three weeks of sham stimulation

Group II: Sham stimulation, then transcranial direct current stimulation (tDCS) Experimental Treatment 2 Interventions

Participants receives three weeks of sham stimulation. After a washout period of 3 months, they then receive three weeks of 20-minute tDCS stimulation

Transcranial Direct Current Stimulation (tDCS) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Transcranial Direct Current Stimulation for:

• Depression
• Stroke rehabilitation
• Chronic pain management
• Research use for various neurological and psychiatric conditions including autism spectrum disorder

Approved in European Union as Transcranial Direct Current Stimulation for:

• Depression
• Stroke rehabilitation
• Chronic pain management
• Research use for various neurological and psychiatric conditions including autism spectrum disorder

Approved in Canada as Transcranial Direct Current Stimulation for:

• Depression
• Stroke rehabilitation
• Chronic pain management
• Research use for various neurological and psychiatric conditions including autism spectrum disorder

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Published Research Related to This Trial

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) shows promise as a non-invasive treatment for Autism Spectrum Disorder (ASD), with 16 studies indicating improvements in social, health, and behavioral problems among participants.

The most common method involved anodal stimulation of the left dorsolateral prefrontal cortex, but the studies varied widely in methodology, highlighting the need for standardized protocols to better assess efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation in Autism Spectrum Disorder: A systematic review and meta-analysis. García-González, S., Lugo-Marín, J., Setien-Ramos, I., et al.[2022]

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 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) is generally considered safe, but there are concerns that it could lead to significant negative effects in healthy individuals.

The scientific community needs to be alerted about the potential risks of tDCS, emphasizing the importance of protecting healthy volunteers from possible harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcranial direct current stimulation in healthy participants. Boccard-Binet, S., Sen, A.[2021]

High Definition transcranial direct current stimulation (HD-tDCS) is safe and well-tolerated in older adults, with no serious adverse events reported during a study involving 101 participants at stimulation intensities of 2 mA and 3 mA.

The study demonstrated effective blinding, as participants could not accurately distinguish between active and sham stimulation, indicating that HD-tDCS can be reliably used in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps. Reckow, J., Rahman-Filipiak, A., Garcia, S., et al.[2020]

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]

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]

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

1. 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 ...

2. nature.com nature.com/articles/s41598-025-93631-z

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- ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10493640/

Effects of transcranial pulse stimulation on autism spectrum ... Cheung et al. reported that there was a 24% reduction in the total Childhood Autism Rating Scale score in the transcranial pulse stimulation group after brain ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33773886/

Transcranial direct current stimulation in Autism Spectrum ... The aim of this study is to conduct a systematic review of the use of tDCS in Autism Spectrum Disorder (ASD).

5. sciencedirect.com sciencedirect.com/science/article/pii/S0149763424002768

A network meta-analysis of non-invasive brain stimulation ... A recent meta-analysis on intellectually able autistic people suggests low-frequency rTMS over the dorsolateral prefrontal cortex (DLPFC) may improve restricted ...

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 ...

7. 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. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2022.721987/full

Effect of Transcranial Direct Current Stimulation on the ... Results show that although conventional treatment can effectively improve the behavioral ability of children with ASD, the use of anode tDCS ...