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

Aggression Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04732052
• Other study ID #: PSIY-688-20
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 31, 2028

Study information

• Verified date: December 2023
• Source: Queen's University
• Contact: Najat Khalifa, MD
• Phone: +6135444900
• Email: nrk2[@]queensu.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2028
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Aggression
• Developmental Disabilities

Intervention

Device:
• Transcranial Direct Current Stimulation
non-invasive brain stimulator

Locations

Country	Name	City	State
Canada	Providence Care Hospital	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Najat Khalifa

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.
Secondary	Trait Impulsivity	Barratt Impulsiveness Scale-11 (BIS-11); The total scores range from 30 - 120, with higher scores indicating higher impulsivity.	Baseline
Secondary	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
Secondary	Treatment Acceptability	Total scores on the tDCS Treatment Acceptability Questionnaire	Up to 72hrs after the third active or sham tDCS treatments.