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

The Use of Transcranial Direct Current Stimulation (tDCS) to Reduce Impulsivity and Aggression in Adults With Developmental Disabilities: The tDCS-RIADD Randomized Controlled Trial Protocol

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.

Study Overview

• Status: Recruiting
• Conditions: Aggression
• Intervention / Treatment: Device: Transcranial Direct Current Stimulation

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Najat Khalifa, MD; Phone Number: +6135444900; Email: nrk2@queensu.ca
• Study Contact Backup: Name: Andrew Bickle, MD; Email: arb12@queensu.ca

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 4X3
      • Recruiting
      • Providence Care Hospital
      • Contact: Najat Khalifa, MD; Phone Number: +6135444900; Email: nrk2@queensu.ca
      • Principal Investigator: Najat Khalifa, MD
      • Sub-Investigator: Andrew Bickle, FRCPC
      • Sub-Investigator: Jessica Jones
      • Sub-Investigator: Drury Andrew
      • Sub-Investigator: Khan Mohammad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active tDCS; 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; non-invasive brain stimulator
Sham Comparator: Sham tDCS; 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; non-invasive brain stimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maladaptive behaviors	Behavior Problems Inventory (BPI); The total frequency scores range from 0-120 and severity of self-injurious behaviour and aggression subscales from 18-54, with higher scores indicating higher frequency and severity	change from baseline one week and one month after the third tDCS session
Intervention side effects	Tracking potential side effects of tDCS/sham treatments using tDCS adverse effects questionnaire.	Up to 72hrs after the first, second, and third active or sham tDCS treatments.
Trait Impulsivity	Barratt Impulsiveness Scale-11 (BIS-11); The total scores range from 30 - 120, with higher scores indicating higher impulsivity.	Baseline
Impulsivity	To determine the effects of tDCS treatment on symptoms of impulsivity measured by the Stop Signals Task (SST)	change from baseline and the same day after the third tDCS sessions
Treatment Acceptability	Total scores on the tDCS Treatment Acceptability Questionnaire	Up to 72hrs after the third active or sham tDCS treatments.

Collaborators and Investigators

• Sponsor: Dr. Najat Khalifa
• Investigators: Study Chair: Muhammad Ayub, MD, Queen's University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: November 27, 2020
• First Submitted That Met QC Criteria: January 29, 2021
• First Posted (Actual): February 1, 2021

Study Record Updates

• Last Update Posted (Estimated): January 1, 2024
• Last Update Submitted That Met QC Criteria: December 22, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Neurodevelopmental Disorders; Aggression; Developmental Disabilities
• Other Study ID Numbers: PSIY-688-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected IPD including all IPD that underlie results in publication.
• IPD Sharing Time Frame: All IPD will be available at study end (in two years) and be available for five years following study end date.
• IPD Sharing Access Criteria: Designated study personnel only
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No