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

NCT04732052 | Recruiting

• 1 other identifier: PSIY-688-20
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aggression

Outcome Measures

Primary Outcomes (1)

• Aggression

  To determine the effect of tDCS treatment on aggressive symptoms measured by The Modified Overt Aggression Scale (MOAS); Total weighted scores range from 0-40, with a higher score indicating more aggressive behavior.

  change from baseline one week and one month after the third tDCS session

Secondary Outcomes (5)

• Maladaptive behaviors

  change from baseline one week and one month after the third tDCS session

• Intervention side effects

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

• Trait Impulsivity

  Baseline

• Impulsivity

  change from baseline and the same day after the third tDCS sessions

• Treatment Acceptability

  Up to 72hrs after the third active or sham tDCS treatments.

Study Arms (2)

Active tDCS

ACTIVE COMPARATOR

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.

Device: Transcranial Direct Current Stimulation

Sham tDCS

SHAM COMPARATOR

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.

Device: Transcranial Direct Current Stimulation

Interventions

Transcranial Direct Current Stimulation DEVICE

non-invasive brain stimulator

Active tDCS; Sham tDCS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Najat Khalifa: lead

Study Sites (1)

Providence Care Hospital

Kingston, Ontario, K7L 4X3, Canada

RECRUITING

MeSH Terms

Conditions

Aggression

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Muhammad Ayub, MD

  Queen's University

  STUDY CHAIR

Central Study Contacts

Najat Khalifa, MD

CONTACT

+6135444900; nrk2@queensu.ca

Andrew Bickle, MD

CONTACT

arb12@queensu.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: November 27, 2020
• First Posted: February 1, 2021
• Study Start: September 1, 2022
• Primary Completion: September 30, 2025
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: All IPD will be available at study end (in two years) and be available for five years following study end date.
• Access Criteria: Designated study personnel only

Locations

CA (1)