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NCT Number: NCT04732052

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

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.

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Key information

Conditions

Aggression Aberrant Motor Behavior in Dementia Behavior Behavioral Symptoms Social Behavior

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Providence Care Hospital

Kingston, Ontario, K7L 4X3, Canada

Location status: Recruiting

Location contact

Andrew Bickle, FRCPC

SUB_INVESTIGATOR

Drury Andrew

SUB_INVESTIGATOR

Jessica Jones

SUB_INVESTIGATOR

Khan Mohammad

SUB_INVESTIGATOR

Najat Khalifa, MD

CONTACT

[email protected]

+6135444900

Najat Khalifa, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Direct Current Stimulation

Device

non-invasive brain stimulator

Primary outcomes

  1. Aggression

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

    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.

Secondary outcomes

  1. Maladaptive behaviors

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

    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

  2. Intervention side effects

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

    Tracking potential side effects of tDCS/sham treatments using tDCS adverse effects questionnaire.

  3. Trait Impulsivity

    Time frame: Baseline

    Barratt Impulsiveness Scale-11 (BIS-11); The total scores range from 30 - 120, with higher scores indicating higher impulsivity.

  4. Impulsivity

    Time frame: change from baseline and the same day after the third tDCS sessions

    To determine the effects of tDCS treatment on symptoms of impulsivity measured by the Stop Signals Task (SST)

  5. Treatment Acceptability

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

    Total scores on the tDCS Treatment Acceptability Questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew Bickle, MD

CONTACT

[email protected]

Najat Khalifa, MD

CONTACT

[email protected]

+6135444900

Sponsors and collaborators

Lead sponsor

Dr. Najat Khalifa

Other

Registry information

Official study title

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

Acronym: tDCS-RIADD

Important dates

Study start
2022
Primary completion
2025
Study completion
2028
First posted
Feb 1, 2021
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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