The Use of Transcranial Direct Current Stimulation (tDCS) in Adults With Developmental Disabilities - Clinical Trial for Aggression | NCT04732052

Back to results

Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Transcranial Direct Current Stimulation

About this trial

This is an interventional treatment trial for Aggression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Providence Care HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active tDCS

Sham tDCS

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Intervention side effects

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

Trait Impulsivity

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

Impulsivity

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

Treatment Acceptability

Total scores on the tDCS Treatment Acceptability Questionnaire

Full Information

NCT ID

NCT04732052

First Posted

November 27, 2020

Last Updated

March 27, 2023

Sponsor

Queen's University

1. Study Identification

Unique Protocol Identification Number

NCT04732052

Brief Title

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

Acronym

tDCS-RIADD

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 1, 2022 (Actual)

Primary Completion Date

September 30, 2025 (Anticipated)

Study Completion Date

December 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Queen's University

4. Oversight

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

Data Monitoring Committee

No

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aggression

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active tDCS

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Sham tDCS

Arm Type

Sham Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Transcranial Direct Current Stimulation

Intervention Description

non-invasive brain stimulator

Primary Outcome Measure Information:

Title

Aggression

Description

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.

Time Frame

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

Secondary Outcome Measure Information:

Title

Maladaptive behaviors

Description

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

Time Frame

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

Title

Intervention side effects

Description

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

Time Frame

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

Title

Trait Impulsivity

Description

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

Time Frame

Baseline

Title

Impulsivity

Description

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

Time Frame

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

Title

Treatment Acceptability

Description

Total scores on the tDCS Treatment Acceptability Questionnaire

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Najat Khalifa, MD

Phone

+6135444900

Email

nrk2@queensu.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Andrew Bickle, MD

Email

arb12@queensu.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Muhammad Ayub, MD

Organizational Affiliation

Queen's University

Official's Role

Study Chair

Facility Information:

Facility Name

Providence Care Hospital

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L 4X3

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Najat Khalifa, MD

Phone

+6135444900

Email

nrk2@queensu.ca

First Name & Middle Initial & Last Name & Degree

Najat Khalifa, MD

First Name & Middle Initial & Last Name & Degree

Andrew Bickle, FRCPC

First Name & Middle Initial & Last Name & Degree

Jessica Jones

First Name & Middle Initial & Last Name & Degree

Drury Andrew

First Name & Middle Initial & Last Name & Degree

Khan Mohammad

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

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

Aggression

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial