tDCS for Developmental Disabilities

(tDCS-RIADD Trial)

Recruiting at 1 trial location

Overseen By Andrew Bickle, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dr. Najat Khalifa

Disqualifiers: Epilepsy, Brain injury, Cochlear implant, 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: 5

Duration: 1 week

60 Participants Needed

Trial Summary

What is the purpose of this trial?

Aggressive behaviours are highly prevalent among people with developmental disabilities, both in community and inpatient or residential settings, with adverse consequences for the individuals involved and others. Some predictive factors, particularly impulsivity, are dynamic with neurobiological underpinnings, and as such amenable to change or neuromodulation using non-invasive brain stimulation techniques. With this in mind, we designed an experimental protocol to determine the efficacy of transcranial Direct Current Stimulation (tDCS) as a non-invasive brain stimulation technique to reduce impulsivity and aggression associated with developmental disability.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Transcranial Direct Current Stimulation (tDCS) for developmental disabilities?

Research shows that transcranial direct current stimulation (tDCS) has been used effectively in treating conditions like autism, ADHD, and dyslexia, which are similar to developmental disabilities. Studies have found it can help reduce symptoms and improve behavior in these disorders. ^{1 2 3 4 5}

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

Transcranial direct current stimulation (tDCS) is generally considered safe for humans, with no serious or lasting side effects reported in over 33,200 sessions across various studies. However, some studies suggest it might cause skin irritation or other minor issues, and there are warnings about potential risks, especially in healthy individuals. ^{6 7 8 9 10}

How is the treatment tDCS unique for developmental disabilities?

Transcranial Direct Current Stimulation (tDCS) is unique because it is a non-invasive, low-cost, and portable treatment that uses a small electrical current to stimulate specific areas of the brain, which is different from other treatments that may involve medication or more invasive procedures. It has been applied in various neurodevelopmental disorders like ADHD, autism, and dyslexia, offering a novel approach compared to traditional therapies. ^{2 11 12 13 14}

Research Team

Muhammad Ayub, MD

Principal Investigator

Queen's University

Eligibility Criteria

This trial is for adults aged 18-64 with developmental disabilities who have shown aggressive behavior in the past month. They must consent to participate, either personally or through a decision-maker. It's not for those with epilepsy, brain injuries, metal in the head, cochlear implants, neuro-stimulators, history of severe tDCS reactions, pacemakers or drug misuse.

Inclusion Criteria

Diagnosis of a developmental disability

History of one or more incidents of aggression in the last month

I am between 18 and 64 years old.

Exclusion Criteria

Current alcohol or drug misuse

Having a cardiac pacemaker or intracardiac lines

History of acquired brain injury

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either three sessions of active or sham tDCS to assess its efficacy in reducing impulsivity and aggression

1 week

3 visits (in-person)

Follow-up

Participants are monitored for changes in aggression and impulsivity one week and one month after treatment

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Transcranial Direct Current Stimulation (tDCS)

Trial Overview The study tests if Transcranial Direct Current Stimulation (tDCS), a non-invasive brain stimulation technique can reduce impulsivity and aggression in adults with developmental disabilities. The efficacy of this intervention will be evaluated experimentally.

Participant Groups

Group I: Active tDCS Active Control 1 Intervention

Transcranial Direct Current Stimulation: Soterix tDCS kit will be used to deliver the stimulation using two sponge electrodes soaked in a saline solution. The stimulation montage will comprise of left anodal Dorsal Lateral Prefrontal cortex (DLPFC) stimulation. The anodal electrode will be placed over the area corresponding to the left DLPFC (F5 of the EEG10-20 international system) and the reference (cathodal) electrode over the right supraorbital ridge. The active stimulation condition will use a constant current of 2mA, delivered via gradual increase and decrease over 10 seconds at the onset and offset of stimulation (current ramps), respectively. The duration a single tDCS session will be 20 minutes.

Group II: Sham tDCS Placebo Group 1 Intervention

Sham Transcranial Direct Current Stimulation: Soterix tDCS kit will be used to deliver the sham stimulation using two sponge electrodes soaked in a saline solution. The sham stimulation montage will comprise of left anodal Dorsal Lateral Prefrontal cortex (DLPFC) stimulation for 10s only. The anodal electrode will be placed over the area corresponding to the left DLPFC (F5 of the EEG10-20 international system) and the reference (cathodal) electrode over the right supraorbital ridge. The sham tDCS is identical to the active tDCS except that the current will be delivered only in the first 10 seconds, after which the stimulation will cease but with the electrodes still in place throughout the session. The duration of each sham tDCS session will be 20 minutes.

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?

Dr. Najat Khalifa

Lead Sponsor

Trials

2

Recruited

120+

Dr. Najat Khalifa

Lead Sponsor

Trials

2

Recruited

120+

Queen's University

Lead Sponsor

Trials

382

Recruited

122,000+

Findings from Research

Transcranial direct current stimulation (tDCS) is a safe intervention for pediatric motor disorders, with no significant difference in dropout rates between active and sham groups, and only mild adverse effects reported, such as tingling and discomfort.

In children with cerebral palsy, tDCS significantly improved gait velocity, stride length, and cadence, suggesting it may enhance certain motor functions, although its effectiveness on balance and upper extremity function remains limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation in Pediatric Motor Disorders: A Systematic Review and Meta-analysis. Saleem, GT., Crasta, JE., Slomine, BS., et al.[2021]

Transcranial direct current stimulation (tDCS) has been shown to be safe and partially effective in treating neurodevelopmental disorders like ADHD, autism spectrum disorder (ASD), and dyslexia, based on a systematic review of 35 randomized controlled trials involving 745 children and adolescents.

Specifically, prefrontal anodal tDCS was more effective for ADHD and ASD, while temporoparietal stimulation was most common for dyslexia, with 88% of multi-session studies reporting significant improvements in at least one outcome variable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of randomized controlled trials on efficacy and safety of transcranial direct current stimulation in major neurodevelopmental disorders: ADHD, autism, and dyslexia. Salehinejad, MA., Ghanavati, E., Glinski, B., et al.[2022]

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 a noninvasive technique that can significantly alter brain functions and has been studied in 340 clinical articles for various conditions, including depression, pain syndromes, and neurodegenerative diseases.

The review provides a comprehensive overview of the clinical applications of tDCS, detailing factors such as study design, sample size, and stimulation parameters, which can help guide future research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comprehensive database of published tDCS clinical trials (2005-2016). Lefaucheur, JP.[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]

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]

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]

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]

Microdermabrasion significantly reduced skin resistance by about 32%, allowing for higher doses of transcranial direct current stimulation (tDCS) without increasing skin sensations or device limitations.

The study found that while microdermabrasion increased perceived sensations slightly when not combined with sonication, overall, it enabled safer and more effective delivery of tDCS by lowering the voltage needed to achieve the same current.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. Chhatbar, PY., Liu, S., Ramakrishnan, V., et al.[2023]

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) effectively increases beta-frequency power in the brain, indicating a readiness for improved cognitive functioning, as observed in a study with 10 healthy participants.

This study is significant as it is the first to simultaneously apply tDCS while recording EEG, providing insights into the dynamic changes in brain activity during stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beta-frequency EEG activity increased during transcranial direct current stimulation. Song, M., Shin, Y., Yun, K.[2014]

Transcranial direct current stimulation (tDCS) is a safe and non-invasive technique that can modulate brain activity using low-intensity direct current, showing promise in treating various mental and neurological disorders.

The review summarizes the effectiveness of tDCS across multiple studies and provides clinical recommendations for its application, highlighting its potential as a therapeutic tool in mental health and neurology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transcranial direct current stimulation in neurology and psychiatry]. Pavlova, EL., Menshikova, AA., Akzhigitov, RG., et al.[2021]

A case study involving a 10-year-old with perinatal stroke established that a tDCS dose of 0.7 mA for 10 minutes is optimal for children, providing similar brain current intensity to adults receiving 1.0 mA, while ensuring safety and tolerability.

The study utilized advanced computational modeling to customize tDCS parameters, suggesting that tailored dosing approaches can enhance the safety and efficacy of tDCS in pediatric applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric stroke and transcranial direct current stimulation: methods for rational individualized dose optimization. Gillick, BT., Kirton, A., Carmel, JB., et al.[2021]

Transcranial direct current stimulation (tDCS) is a low-cost and portable technique that can modulate brain function, making it a promising tool for treating psychiatric disorders.

While tDCS has been widely used in research to study brain processes, its specific effects on psychiatric patients are not well understood, highlighting the need for further investigation into its mechanisms of action and optimal use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The application of tDCS in psychiatric disorders: a brain imaging view. Baeken, C., Brunelin, J., Duprat, R., et al.[2020]

References

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

Transcranial Direct Current Stimulation in Pediatric Motor Disorders: A Systematic Review and Meta-analysis. [2021]

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

A systematic review of randomized controlled trials on efficacy and safety of transcranial direct current stimulation in major neurodevelopmental disorders: ADHD, autism, and dyslexia. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation for hyperactivity and noncompliance in autistic disorder. [2019]

4. France pubmed.ncbi.nlm.nih.gov

A comprehensive database of published tDCS clinical trials (2005-2016). [2022]

5. 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]

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

Safety of transcranial direct current stimulation in healthy participants. [2021]

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]

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

Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps. [2020]

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

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. [2023]

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

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Beta-frequency EEG activity increased during transcranial direct current stimulation. [2014]

12. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Transcranial direct current stimulation in neurology and psychiatry]. [2021]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Pediatric stroke and transcranial direct current stimulation: methods for rational individualized dose optimization. [2021]

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

The application of tDCS in psychiatric disorders: a brain imaging view. [2020]