AggressiontDCS-RIADDNCT04732052
The Use of Transcranial Direct Current Stimulation (tDCS) in Adults With Developmental Disabilities
A study testing Transcranial Direct Current Stimulation in people with Aggression, run by Dr. Najat Khalifa at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Aggression
- What is being tested?
- Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2022to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- History of severe adverse reaction to tDCS
- Having a cardiac pacemaker or intracardiac lines
- Current alcohol or drug misuse
- Having a sensitive scalp
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Andrew Bickle, MD contact
Canada1 site, 1 recruiting
- Recruiting
Providence Care Hospital
Kingston, Ontario, K7L 4X3
Najat Khalifa, MD, +6135444900, nrk2@queensu.ca
Najat Khalifa, MD
About this study
Official 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
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.
Read the 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.
- Conditions
- Aggression
- Being tested
- Transcranial Direct Current Stimulation
- Medical subject headings
- Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDevice
non-invasive brain stimulator
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: change from baseline one week and one month after the third tDCS session
Secondary outcomes (5)
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
Measured: 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.
Measured: 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.
Measured: Baseline
Impulsivity
To determine the effects of tDCS treatment on symptoms of impulsivity measured by the Stop Signals Task (SST)
Measured: change from baseline and the same day after the third tDCS sessions
Treatment Acceptability
Total scores on the tDCS Treatment Acceptability Questionnaire
Measured: Up to 72hrs after the third active or sham tDCS treatments.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start1 Sep 2022
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AggressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Najat Khalifa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Najat Khalifa, Queen's University
- Investigators
- Muhammad Ayub, MD, Study chair, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04732052
- Sponsor's protocol ID
- PSIY-688-20
- Acronym
- tDCS-RIADD
- Status last verified
- Aug 2026
- First submitted
- 27 Nov 2020
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD including all IPD that underlie results in publication.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04732052
- Acronym / sponsor ID
- tDCS-RIADD / PSIY-688-20
- Conditions
- Aggression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dr. Najat KhalifaUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 1 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Active comparator | Device: Transcranial Direct Current StimulationTranscranial 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 tDCS | Sham comparator | Device: Transcranial Direct Current StimulationSham 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current Stimulationnon-invasive brain stimulator | Device | Active tDCS, Sham tDCS |
Primary outcome
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.
5 secondary outcomes
Maladaptive behaviors
Time frame: change from baseline one week and one month after the third tDCS session
Intervention side effects
Time frame: Up to 72hrs after the first, second, and third active or sham tDCS treatments.
Trait Impulsivity
Time frame: Baseline
Impulsivity
Time frame: change from baseline and the same day after the third tDCS sessions
Treatment Acceptability
Time frame: Up to 72hrs after the third active or sham tDCS treatments.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: Yes. All collected IPD including all IPD that underlie results in publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew Bickle, MD contact
Muhammad Ayub, MD study chair
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation in people with Aggression, run by Dr. Najat Khalifa at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Najat Khalifa, MD (+6135444900, nrk2@queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aggression (time frame: change from baseline one week and one month after the third tDCS session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.