Non-invasive Brain Stimulation for Autism

Recruiting in Palo Alto (17 mi)

Overseen by Barbie Zimmerman-Bier, M.D.

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

Although many children diagnosed with autism spectrum disorder (ASD) make significant progress in learning and their cognitive skills improve with applied behavior analysis (ABA), there are a significant number of children who show an absence or a plateau in various skills. Deficits in executive functioning are likely to be involved in many of these cognitive and learning disabilities due to poor functioning of the prefrontal cortex. Currently, the use of biological methods for improving learning and cognition is largely unexplored in research and practice. The aim of this study is to use of transcranial direct current stimulation (tDCS) in combination with ABA to improve the acquisition of educational programs for students with ASD. tDCS is a low-level electrical neurostimulation and is most effective when used in combination with an active training or teaching, facilitating the neuronal circuits used for that task. tDCS has been used for various indications over a couple of decades and has been shown to be very safe and has been well-tolerated by children with ASD. The mechanism of tDCS is not clear, however animal studies show that tDCS can stimulate the flow of calcium ions through channels in the astrocytes, activating them, and facilitating their role in synapse formation and therefore learning.

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 data supports the effectiveness of the treatment Transcranial Direct Current Stimulation (tDCS) for autism?

Research shows that transcranial direct current stimulation (tDCS) can help improve sociability, behavior, health, and physical conditions in children with autism spectrum disorder (ASD). Studies found significant improvements in these areas after tDCS treatment compared to a control group, with no reported side effects.

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Is transcranial direct current stimulation (tDCS) safe for humans?

Transcranial direct current stimulation (tDCS) is generally considered safe, with mild and temporary side effects like itching, tingling, and headaches. However, there are warnings that it could potentially cause serious conditions, so caution is advised, especially for healthy individuals.

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How is transcranial direct current stimulation (tDCS) different from other treatments for autism?

Transcranial direct current stimulation (tDCS) is a unique, non-invasive treatment that uses a mild electrical current to stimulate specific areas of the brain, such as the prefrontal and motor areas, which are associated with autism symptoms. Unlike medications, tDCS does not involve drugs and has shown potential improvements in sociability, behavior, and physical conditions in children with autism without reported side effects.

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Eligibility Criteria

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.)

Trial Timeline

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

Participant Groups

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.

Group I: Active tDCS first 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 first 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, Australia 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

🇦🇺 Approved in Australia as Transcranial Direct Current Stimulation for:

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Department of Pediatrics, Division of Pediatric Neurology, Robert Wood Johnson Medical School New Brunswick, NJ

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey Lead Sponsor

New York State Institute for Basic Research Collaborator

Boston Children's Hospital Collaborator

References

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

Transcranial direct current stimulation in children with autism spectrum disorder: a systematic scoping review. [2019] Our aim was to review available studies which test transcranial direct current stimulation (tDCS) to reduce symptom severity in children with autism spectrum disorder (ASD).

2. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of anodal transcranial direct current stimulation on autism: a randomized double-blind crossover trial. [2018] The aim of this study was to evaluate the Childhood Autism Rating Scale (CARS), Autism Treatment Evaluation Checklist (ATEC), and Children's Global Assessment Scale (CGAS) after anodal transcranial direct current stimulation (tDCS) in individuals with autism. Twenty patients with autism received 5 consecutive days of both sham and active tDCS stimulation (1 mA) in a randomized double-blind crossover trial over the left dorsolateral prefrontal cortex (F3) for 20 minutes in different orders. Measures of CARS, ATEC, and CGAS were administered before treatment and at 7 days posttreatment. The result showed statistical decrease in CARS score (P

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] Dysfunctional frontal cortical areas associated with clinical features are observed in children with autism spectrum disorder (ASD). This study attempted to identify any potential therapeutic effects of bilateral anodal transcranial direct current stimulation (tDCS) applied over the left and right prefrontal and motor areas on the clinical characteristics of children with ASD. Fifty children with confirmed ASD medical diagnoses were divided equally and randomly into a tDCS treatment group and a control group. The tDCS treatment group underwent 10 sessions (20-min durations, five per week) of bilateral anodal tDCS stimulation applied simultaneously over the left and right prefrontal and motor areas, whereas the control group underwent the same procedures but with the use of sham tDCS stimulation. Total scores and sub-scores of autism treatment evaluation checklist (ATEC) (language and communication; sociability; sensory awareness; and behavioral, health, and physical conditions) were measured before and after the tDCS treatment sessions of both groups. There were significant decreases in total ATEC scores (P = 0.014), sociability sub-scores (P = 0.021), and behavioral, health, and physical condition sub-scores (P = 0.011) in the tDCS treatment group. No significant changes were observed in total ATEC scores and sub-scores in the control group. In conclusion, compared to the control group, bilateral anodal tDCS showed potential therapeutic effects on children with ASD in terms of improvements in sociability, behavior, health, and physical conditions with no reported side effects. Autism Res 2020, 13: 828-836. © 2020 International Society for Autism Research, Wiley Periodicals, Inc. LAY SUMMARY: Dysfunctional frontal cortical areas are associated with clinical features in children with autism spectrum disorder (ASD). Transcranial direct current stimulation (tDCS) is found to be a safe, noninvasive method to stimulate cortical regions and thus have therapeutic effects on children with ASD. © 2020 International Society for Autism Research, Wiley Periodicals, Inc.

4. 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] To compare the efficacy of 0, 5, and 20 sessions of transcranial direct current stimulation (tDCS) for reducing symptoms of autism spectrum disorder (ASD).

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

Transcranial direct current stimulation for hyperactivity and noncompliance in autistic disorder. [2019] To evaluate the safety, efficacy, and feasibility of inhibitory transcranial direct current stimulation (tDCS) for the treatment of behavioural abnormalities of autistic patients.

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

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022] This review updates and consolidates evidence on the safety of transcranial Direct Current Stimulation (tDCS). Safety is here operationally defined by, and limited to, the absence of evidence for a Serious Adverse Effect, the criteria for which are rigorously defined. This review adopts an evidence-based approach, based on an aggregation of experience from human trials, taking care not to confuse speculation on potential hazards or lack of data to refute such speculation with evidence for risk. Safety data from animal tests for tissue damage are reviewed with systematic consideration of translation to humans. Arbitrary safety considerations are avoided. Computational models are used to relate dose to brain exposure in humans and animals. We review relevant dose-response curves and dose metrics (e.g. current, duration, current density, charge, charge density) for meaningful safety standards. Special consideration is given to theoretically vulnerable populations including children and the elderly, subjects with mood disorders, epilepsy, stroke, implants, and home users. Evidence from relevant animal models indicates that brain injury by Direct Current Stimulation (DCS) occurs at predicted brain current densities (6.3-13 A/m(2)) that are over an order of magnitude above those produced by conventional tDCS. To date, the use of conventional tDCS protocols in human trials (≤40 min, ≤4 milliamperes, ≤7.2 Coulombs) has not produced any reports of a Serious Adverse Effect or irreversible injury across over 33,200 sessions and 1000 subjects with repeated sessions. This includes a wide variety of subjects, including persons from potentially vulnerable populations.

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] Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation investigated as a treatment for several neuropsychiatric disorders. Notwithstanding tDCS-induced adverse events (AEs) are considered to be low and transient, systematic review analyses on safety and tolerability of tDCS derive mostly from single-session studies.

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

Safety of transcranial direct current stimulation in healthy participants. [2021] •Transcranial Direct Current Stimulation (tDCS) is mostly reported as safe.•BUT it could induce life-changing conditions in healthy volunteers.•Scientific community MUST be warned that tDCS may be harmful and protect healthy volunteers.

9. England pubmed.ncbi.nlm.nih.gov

A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. [2022] Transcranial direct current stimulation (tDCS) is a non-invasive method of brain stimulation that has been intensively investigated in clinical and cognitive neuroscience. Although the general impression is that tDCS is a safe technique with mild and transient adverse effects (AEs), human data on safety and tolerability are largely provided from single-session studies in healthy volunteers. In addition the frequency of AEs and its relationship with clinical variables is unknown. With the aim of assessing tDCS safety in different conditions and study designs, we performed a systematic review and meta-analysis of tDCS clinical trials. We assessed Medline and other databases and reference lists from retrieved articles, searching for articles from 1998 (first trial with contemporary tDCS parameters) to August 2010. Animal studies, review articles and studies assessing other neuromodulatory techniques were excluded. According to our eligibility criteria, 209 studies (from 172 articles) were identified. One hundred and seventeen studies (56%) mentioned AEs in the report. Of these studies, 74 (63%) reported at least one AE and only eight studies quantified AEs systematically. In the subsample reporting AEs, the most common were, for active vs. sham tDCS group, itching (39.3% vs. 32.9%, p>0.05), tingling (22.2% vs. 18.3%, p>0.05), headache (14.8% vs. 16.2%, p>0.05), burning sensation (8.7% vs. 10%, p>0.05) and discomfort (10.4% vs. 13.4%, p>0.05). Meta-analytical techniques could be applied in only eight studies for itching, but no definite results could be obtained due to between-study heterogeneity and low number of studies. Our results suggested that some AEs such as itching and tingling were more frequent in the tDCS active group, although this was not statistically significant. Although results suggest that tDCS is associated with mild AEs only, we identified a selective reporting bias for reporting, assessing and publishing AEs of tDCS that hinders further conclusions. Based on our findings, we propose a revised adverse effects questionnaire to be applied in tDCS studies in order to improve systematic reporting of tDCS-related AEs.