Recruiting

tDCS

Sponsor:

Dr. Najat Khalifa

Code:

NCT04732052

Conditions

Aggression

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Transcranial Direct Current Stimulation

Study Details

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

Study ID

NCT04732052

Start date

Sep 1, 2022

Status verified date

Aug, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Transcranial Direct Current Stimulation

non-invasive brain stimulator

Primary outcome measure

  • Aggression [ Time Frame: change from baseline one week and one month after the third tDCS session ]

Central Contacts and Locations

Central contacts

Najat Khalifa, MD

+6135444900nrk2@queensu.ca

Andrew Bickle, MD

arb12@queensu.ca

Locations

Providence Care Hospital

Recruiting

Kingston, Ontario, Canada, K7L 4X3

Contacts

Najat Khalifa, MD

+6135444900nrk2@queensu.ca

Principal Investigator:

Najat Khalifa, MD

More Information

Sponsor

Dr. Najat Khalifa

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dr. Najat Khalifa on 2026-08-12.