Transcranial Direct Current Stimulation for Autism Spectrum Disorder

(tDCS Trial)

Overseen By Eric London, M.D.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: New York State Institute for Basic Research

Must not be taking: Antiseizure, Antidepressants, Antipsychotics, others

Disqualifiers: Seizures, Neurological disorders, Metal implants, others

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

Compensation: Varies

Number of Visits: 47

Duration: 5 months

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help children with autism improve their learning skills by combining a special type of brain stimulation with behavior therapy. The treatment, transcranial direct current stimulation (tDCS), uses a mild electrical current to enhance learning during therapy sessions. The trial seeks to determine if this method can assist children already in an Applied Behavior Analysis (ABA) program who are not making the expected progress. Children aged 5 to 12 with autism, currently enrolled in an ABA program and able to wear the tDCS device, may be suitable for this study. As an unphased trial, this study offers a unique opportunity for children to potentially benefit from an innovative treatment approach.

Will I have to stop taking my current medications?

You may need to stop taking certain medications to participate in this trial. Specifically, if you are on medications like anti-seizure drugs, serotonin reuptake inhibitors, or any drugs that affect dopamine, norepinephrine, or lower seizure threshold, you might be excluded from the study. It's best to discuss your current medications with the trial team to see if they affect your eligibility.

What prior data suggests that transcranial direct current stimulation is safe for children with autism spectrum disorder?

Research shows that Transcranial Direct Current Stimulation (tDCS) is generally safe for children with autism spectrum disorder (ASD). Studies have found that children can undergo tDCS treatments for several weeks without serious side effects. For instance, one study showed that children with ASD completed a three-week tDCS treatment without any major problems.

Although the exact mechanism of tDCS remains unclear, it uses gentle electrical currents to support brain activity related to learning. This method has been safely used for various conditions over the years. When tDCS is applied, some people might feel a slight tingling, but this sensation is usually mild and temporary.

Overall, evidence from earlier studies suggests that tDCS is a safe option for children with ASD, especially when combined with therapies like applied behavior analysis (ABA). ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcranial direct current stimulation (tDCS) for Autism Spectrum Disorder because it represents a novel technique that could complement existing therapies like behavioral interventions and medications. Unlike traditional treatments, tDCS uses a non-invasive method of delivering a mild electrical current to the brain, potentially enhancing neural connectivity and improving symptoms. This technique is particularly promising because it can be used alongside Applied Behavior Analysis (ABA) therapy, potentially boosting its effectiveness. Furthermore, tDCS is generally well-tolerated, with minimal side effects, making it an attractive option for individuals seeking alternative or adjunctive treatments for autism.

What evidence suggests that transcranial direct current stimulation is effective for autism spectrum disorder?

Research has shown that transcranial direct current stimulation (tDCS) can improve symptoms in children with autism spectrum disorder (ASD). In this trial, participants will receive both active and sham tDCS in a randomized order. Studies have found that children with ASD who received active tDCS demonstrated better social communication, emotional control, and thinking skills. Specifically, using tDCS on the front part of the brain has been linked to less severe autism symptoms and improved social skills. Additionally, tDCS sessions have helped school-aged boys with ASD better recognize facial emotions. Overall, tDCS appears to be a promising tool for enhancing learning and thinking skills, especially when combined with therapies like applied behavior analysis (ABA). ^{1 3 6 7 8}

Who Is on the Research Team?

J. Helen Yoo, Ph.D.

Principal Investigator

New York State Institute for Basic Research

Are You a Good Fit for This Trial?

This trial is for children with Autism Spectrum Disorder who have shown limited progress or plateaued in skill development, despite Applied Behavior Analysis therapy. Specific eligibility criteria are not provided.

Inclusion Criteria

My medical and mental health treatments have been stable for at least 4 weeks.

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

I am between 5 and 12 years old and have autism.

Exclusion Criteria

I have had a seizure in the past two years.

I have a current skin condition.

Skull defect

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Baseline

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

4 weeks

1 visit (in-person)

Treatment

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

5 months

40 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment using EEG and PDDBI

5 months

5 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Direct Current Stimulation

Trial Overview The study tests transcranial direct current stimulation (tDCS) combined with ABA therapy to enhance learning in children with ASD. tDCS involves low-level electrical neurostimulation aimed at improving cognitive function and learning abilities.

How Is the Trial Designed?

Group I: Active tDCS Experimental Treatment 1 Intervention

Active stimulation first, then crossover to Sham stimulation. Each participant will receive BOTH sham and 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 1 Intervention

Sham stimulation first, then crossover to Active stimulation. Each participant will receive BOTH sham and 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.

Who Is Running the Clinical Trial?

New York State Institute for Basic Research

Lead Sponsor

Trials

7

Recruited

960+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36394093/

Long-term effects of transcranial direct current stimulation ... 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 ...

2. 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 ...

3. 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- ...

4. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1407267/full

Effects of transcranial direct current stimulation on brain ... Our study investigated the effects of a two-week regimen of tDCS targeting the left dorsolateral prefrontal cortex (DLPFC) in children with ASD.

5. brieflands.com brieflands.com/journals/ijpbs/articles/121995

Effectiveness of Anodal Transcranial Direct Current ... According to the results of the present study, ten sessions of tDCS (with an intensity of 2 mA) could improve the FER deficit in school-aged boys with ASD. This ...

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. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2833028

Transcranial Pulsed Current Stimulation and Social ... These findings suggest that prefrontal-cerebellar tPCS is a safe and efficacious treatment to improve social functioning in children aged 3 to 14 years with ...