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

ConditionAggression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorDr. Najat Khalifa

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transcranial Direct Current Stimulation

    Device

    non-invasive brain stimulator

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Active tDCSActive comparator 1 intervention
Group B: Sham tDCSSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

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

Secondary outcomes

1

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

Time frame
change from baseline one week and one month after the third tDCS session
2

Intervention side effects

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.
3

Trait Impulsivity

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

Time frame
Baseline
4

Impulsivity

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dr. Najat Khalifa

Lead sponsor

Queen's University

Sponsor institution

Source ClinicalTrials.gov
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