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Non-invasive Brain Stimulation

tDCS for Developmental Disabilities (tDCS-RIADD Trial)

N/A

Recruiting

Led By Muhammad Ayub, MD

Research Sponsored by Dr. Najat Khalifa

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults aged 18-64 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 72hrs after the third active or sham tdcs treatments.

Awards & highlights

tDCS-RIADD Trial Summary

This trial found that tDCS can help to reduce impulsive and aggressive behaviours in people with developmental disabilities.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects of tDCS may include discomfort at the stimulation site on the scalp, itching or tingling during treatment sessions and fatigue. There might also be temporary headaches or nausea post-treatment.

tDCS-RIADD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 64 years old.

tDCS-RIADD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 72hrs after the first, second, and third active or sham tdcs treatments.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 72hrs after the first, second, and third active or sham tdcs treatments.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 72hrs after the first, second, and third active or sham tdcs treatments. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Aggression

Secondary outcome measures

Impulsivity

Intervention side effects

Maladaptive behaviors

+2 more

tDCS-RIADD Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active tDCSActive Control1 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 tDCSPlacebo Group1 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.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

Dr. Najat KhalifaLead Sponsor

1 Previous Clinical Trials

60 Total Patients Enrolled

Queen's UniversityLead Sponsor

365 Previous Clinical Trials

120,357 Total Patients Enrolled

Muhammad Ayub, MDPrincipal InvestigatorQueen's University

Media Library

Transcranial Direct Current Stimulation (tDCS) (Non-invasive Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04732052 — N/A

Aggression Research Study Groups: Active tDCS, Sham tDCS

Aggression Clinical Trial 2023: Transcranial Direct Current Stimulation (tDCS) Highlights & Side Effects. Trial Name: NCT04732052 — N/A

Transcranial Direct Current Stimulation (tDCS) (Non-invasive Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04732052 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are senior citizens excluded from participating in this research trial?

"The age bracket for this research endeavor is between 18 and 65."

Answered by AI

Does this experiment continue to admit participants?

"The information published on clinicaltrials.gov suggests that this medical study is not currently recruiting patients; it was first listed on September 1st 2020 and was last updated on January 25th 2022. Though, other trials are actively looking for volunteers at the moment with 94 more studies available to consider."

Answered by AI

Am I able to participate in this medical exploration?

"Sixty individuals with a history of aggression between 18 and 65 years old are invited to take part in this experiment. Eligible applicants must possess the following: maturity aged between 18-64, diagnosis of developmental disorder, evidence of one or more episodes within the last month, and authorization from either themselves or their lawfully appointed representative."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Use of Transcranial Direct Current Stimulation (tDCS) in Adults With Developmental Disabilities

Dr. Najat Khalifa 2022. "The Use of Transcranial Direct Current Stimulation (tDCS) in Adults With Developmental Disabilities". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04732052.

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