The Use of Transcranial Direct Current Stimulation (tDCS) in Adults with Developmental Disabilities (tDCS-RIADD)

Dr. Najat Khalifa

Status: Enrolling

Conditions: Aggression

Treatments: Device: Transcranial Direct Current Stimulation

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT04732052

PSIY-688-20

Details and patient eligibility

About

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.

Full description

This study aims to assess the efficacy of anodal tDCS in modulating Rapid Response Impulsivity (RRI) and reducing incidents of aggression in people with developmental disabilities is residential or hospital settings. Using a single blind, parallel arms, randomized controlled trial design, adults (n=60) aged 18 to 65 with developmental disabilities, who have a history of impulsivity leading to aggression, will be randomised to receive either repetitive anodal or sham tDCS. Enrolled participants will receive either three treatment sessions of tDCS or sham tDCS. Behavioural and impulsivity will be measured before and immediately after treatment, one week, and one month after treatment end. Data will be analysed in SPSS using repeated measures ANOVA.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged 18-64 years
• 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

• History of epilepsy or seizures
• History of acquired brain injury
• Having metal in the brain/skull, e.g. splinters, fragments or clips
• Having a cochlear implant
• Having an implanted neuro-stimulator (e.g. direct brain stimulation, epidural/subdural stimulation, vagal nerve stimulation)
• History of brain surgery of procedure
• History of severe adverse reaction to tDCS
• Having a cardiac pacemaker or intracardiac lines
• Current alcohol or drug misuse
• Having a sensitive scalp

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Active tDCS

Active Comparator group

Description:

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.

Treatment:

Device: Transcranial Direct Current Stimulation

Sham tDCS

Sham Comparator group

Description:

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.

Treatment:

Device: Transcranial Direct Current Stimulation