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Non-invasive Brain Stimulation

tDCS for Developmental Disabilities (tDCS-RIADD Trial)

N/A

Recruiting

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

Must not have

History of epilepsy or seizures

History of brain surgery of procedure

Timeline

Screening 3 weeks

Treatment Varies

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

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 64 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of epilepsy or seizures.

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I have had brain surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline and the same day after the third tdcs sessions

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline and the same day after the third tdcs sessions

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline and the same day after the third tdcs sessions for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Aggression

Secondary study objectives

Impulsivity

Intervention side effects

Maladaptive behaviors

+2 more

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 / 3Eligibility criteria met