Non-invasive Brain Stimulation for Autism

Overseen By Eric B London, M.D.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Must not be taking: Antiseizure, Antipsychotics, Stimulants, Barbiturates

Disqualifiers: Metal implants, Seizure disorder, 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: 41

Duration: 5 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether transcranial direct current stimulation (tDCS), a gentle brain stimulation technique, can enhance learning in children with autism spectrum disorder (ASD) who are already receiving applied behavior analysis (ABA) therapy. tDCS involves applying a low-level electrical current to the head to boost brain activity, especially when paired with active learning. The trial targets children aged 5 to 12 with autism who are already in a structured ABA program and can handle the tDCS setup. Participants will experience both active and sham (inactive) tDCS sessions, with the order determined randomly. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve learning outcomes for children with ASD.

Will I have to stop taking my current medications?

The trial requires that participants have stable medical and behavioral treatments for at least 4 weeks before and during the study. However, if you are taking certain medications, such as anti-seizure drugs, serotonin reuptake inhibitors, or medications affecting dopamine, norepinephrine, or NMDA receptors, you may be excluded from participating.

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 and well-tolerated, particularly for children with autism spectrum disorder (ASD). Studies have found no reports of serious side effects with tDCS use. Most children find it comfortable, and any side effects are typically mild. tDCS has been used safely in various settings for years. It involves applying a small electrical current to the head, which might cause a slight tingling sensation. This sensation is usually temporary and not harmful. Overall, the strong safety record of tDCS makes it a promising option for improving learning and thinking skills in children with ASD. ^{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 approach that could complement existing behavioral therapies like ABA (Applied Behavior Analysis). Unlike standard medications for autism that often focus on managing symptoms through chemical means, tDCS uses a mild electrical current to potentially enhance brain function directly. This technique might improve social and communication skills by targeting specific areas of the brain involved in these functions, offering a novel mechanism of action that stands apart from traditional pharmacological treatments. Additionally, the crossover design of the trial ensures that every participant receives both active and sham stimulation, providing robust data on the potential benefits of tDCS.

What evidence suggests that transcranial direct current stimulation (tDCS) is effective for autism?

Research shows that transcranial direct current stimulation (tDCS), which participants in this trial may receive, can help children with autism spectrum disorder (ASD) improve in several areas. Studies have found that tDCS can enhance social skills, emotional control, and thinking abilities. It works especially well alongside teaching methods like applied behavior analysis (ABA), as it prepares the brain for learning. The method is safe and generally easy for children to handle. Although the exact mechanism remains unclear, it likely helps the brain form new connections that support learning. This suggests that tDCS could be a promising way to help children with ASD overcome learning challenges. ^{2 4 6 7 8}

Who Is on the Research Team?

Barbie Zimmerman-Bier, M.D.

Principal Investigator

Department of Pediatrics, Division of Pediatric Neurology Robert Wood Johnson Medical School (RWJMS)

Are You a Good Fit for This Trial?

This trial is for children aged 5-12 with autism, enrolled in an ABA program. They must have stable medical and behavioral treatments for at least a month before the study and be able to wear tDCS equipment after desensitization training. Children with metal implants, recent seizures, certain medication use (like serotonin reuptake inhibitors or dopamine affecting drugs), severe neurological issues, sensory impairments, or those on medications that might interfere with tDCS are excluded.

Inclusion Criteria

Enrolled in an ABA program (school or in-home) supervised by a Board Certified Behavior Analyst (BCBA)

, are required It is necessary to have stable medical and behavioural treatments for at least 4 weeks prior to and during the study.

Boys and girls between the ages of 5 and 12 who have autism.

Exclusion Criteria

You have a hole or opening in your skull.

You are taking medications that affect dopamine, such as drugs for Parkinson's disease or antipsychotic medications.

Any implanted metal device (heart pacemaker, cochlear implant, surgical clips, etc.)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline assessments including Leiter-3 nonverbal intelligence and Vineland Adaptive Behavior Scales

1 week

1 visit (in-person)

Treatment

Participants receive 40 sessions of tDCS (20 active, 20 sham) during ABA therapy, each lasting 20 minutes

5 months

40 visits (in-person)

Follow-up

Participants are monitored for changes in executive function and ASD symptoms using BRIEF, PDDBI, and EEG

5 months

Monthly assessments

What Are the Treatments Tested in This Trial?

Interventions

• Sham tDCS
• Transcranial Direct Current Stimulation (tDCS)

Trial Overview The trial tests if transcranial direct current stimulation (tDCS) can help improve learning when combined with applied behavior analysis (ABA). It involves low-level electrical neurostimulation aimed at enhancing brain function related to learning. Participants will receive either actual tDCS or a sham (placebo) version without active stimulation.

How Is the Trial Designed?

Group I: Active tDCS Experimental Treatment 2 Interventions

\[Active stimulation first, then crossover to Sham stimulation\] Each participant will receive BOTH sham or active tDCS but the order of each will be randomized. The active tDCS and sham are procedurally identical. Participants in both arms will have the initial tingling sensation and the active tDCS stimulation will CONTINUE for 20 minutes at 1 mA (milliamps). All tDCS sessions will occur during ABA therapy.

Group II: Sham tDCS Placebo Group 2 Interventions

\[Sham stimulation first, then crossover to Active stimulation\] Each participant will receive BOTH sham or active tDCS but the order of each will be randomized. The active tDCS and sham are procedurally identical. Participants in both arms will have the initial tingling sensation, except in sham stimulation, the current will be DISCONTINUED after 30 seconds while the power indicator remains on for the remainder of 20 minutes at 0 mA (milliamps). All tDCS sessions will occur during ABA therapy.

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?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

New York State Institute for Basic Research

Collaborator

Trials

7

Recruited

960+

Boston Children's Hospital

Collaborator

Trials

801

Recruited

5,584,000+

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) is generally considered safe, with mild and transient adverse effects reported in clinical trials, but the frequency and relationship of these effects with clinical variables remain unclear due to selective reporting bias.

Out of 209 studies reviewed, 117 mentioned adverse effects, with common issues like itching and tingling reported more frequently in the active tDCS group, although these differences were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Brunoni, AR., Amadera, J., Berbel, B., et al.[2022]

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]

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]

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 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 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]

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]

Citations

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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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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. 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. 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).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7916366/

Systematic Review on the Safety and Tolerability of ... Background: Transcranial direct current stimulation (tDCS) is a safe, tolerable, and acceptable technique in adults.

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 ...