60 Participants Needed

tDCS for Developmental Disabilities

(tDCS-RIADD Trial)

Recruiting at 1 trial location
NK
AB
Overseen ByAndrew Bickle, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Dr. Najat Khalifa
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

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.12345

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.678910

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.711121314

Who Is on the Research Team?

MA

Muhammad Ayub, MD

Principal Investigator

Queen's University

Are You a Good Fit for This Trial?

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
Consent to participate in the trial by the individual or their Substitute Decision Maker

Exclusion Criteria

Current alcohol or drug misuse
Having a cardiac pacemaker or intracardiac lines
History of acquired brain injury
See 7 more

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: Active tDCSActive Control1 Intervention
Group II: Sham tDCSPlacebo Group1 Intervention

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:
🇪🇺
Approved in European Union as Transcranial Direct Current Stimulation for:
🇨🇦
Approved in Canada as Transcranial Direct Current Stimulation for:

Find a Clinic Near You

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+

Published Research Related to This Trial

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.
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.
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.
Transcranial direct current stimulation for hyperactivity and noncompliance in autistic disorder.D'Urso, G., Bruzzese, D., Ferrucci, R., et al.[2019]

Citations

Transcranial Direct Current Stimulation in Pediatric Motor Disorders: A Systematic Review and Meta-analysis. [2021]
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]
Transcranial direct current stimulation for hyperactivity and noncompliance in autistic disorder. [2019]
A comprehensive database of published tDCS clinical trials (2005-2016). [2022]
Long-term effects of transcranial direct current stimulation in the treatment of autism spectrum disorder: A randomized controlled trial. [2023]
Safety of transcranial direct current stimulation in healthy participants. [2021]
A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. [2018]
Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps. [2020]
Microdermabrasion facilitates direct current stimulation by lowering skin resistance. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]
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]
Pediatric stroke and transcranial direct current stimulation: methods for rational individualized dose optimization. [2021]
14.United Statespubmed.ncbi.nlm.nih.gov
The application of tDCS in psychiatric disorders: a brain imaging view. [2020]
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