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Behavioural Intervention
Combination of tDCS and Cognitive Rehabilitation for Mild Cognitive Impairment and Late Life Depression
N/A
Waitlist Available
Led By Tarek Rajji, MD
Research Sponsored by Centre for Addiction and Mental Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 8 weeks after baseline.
Awards & highlights
Study Summary
This trial will test whether an at-home intervention can prevent cognitive decline in people at risk for Alzheimer's disease.
Who is the study for?
This trial is for people over 60 with mild cognitive impairment (MCI) or a history of depression. Participants must meet specific criteria, have had depression in the past decade but currently have low depressive symptoms, and be able to communicate in English. They need a study partner who knows them well. Those with schizophrenia, bipolar disorder, OCD, or recent substance abuse can't join.Check my eligibility
What is being tested?
The trial tests an at-home intervention combining transcranial direct current stimulation (tDCS) and cognitive rehabilitation (CR) to see if it can prevent worsening memory and thinking problems in those at risk for Alzheimer's disease.See study design
What are the potential side effects?
Potential side effects from tDCS may include discomfort at the electrode sites on the head such as itching or tingling during stimulation, headache, fatigue, nausea or insomnia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 8 weeks after baseline.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 8 weeks after baseline.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of training a facilitator (caregiver) to facilitate the administration of CR+tDCS to their "patient" partner as indicated by a positive response in the Perceived Competence Scale at 24 months from study baseline.
Fidelity to delivering home-based CR+tDCS by a facilitator (caregiver) to the participant as indicated by the compliance rate during the induction phase and boosters.
Secondary outcome measures
Assess change in Quality of Life Scale scores among patients between baseline and at the end of the 8-week course.
Measure the change in Quality of Life Scale scores among facilitators between baseline and at the end of the 8-week course.
Measure the change in cognition (as indicated by a change in the Screen for Cognitive Impairment in Psychiatry) among facilitators between baseline and at the end of the 8-week course
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Receive tDCS + CRExperimental Treatment1 Intervention
Receive tDCS+CR: Over the course of 8 weeks, for 5 days a week, participants designated a 'Patient' will receive active tDCS &CR at-home. tDCS will be administered during the 2 hour CR sessions for 30 min/day. The tDCS montage will be bifrontal91 with 1 large anode placed over Fz and the cathode over Iz. The direct current will be 2 mA (current density = 0.57 A/m2). CR sessions will utilize didactic and computerized drill-based exercises which focus on practice and repetition of neurocognitive ability areas that are affected in depression such as attention, processing speed, executive function, verbal memory, and working memory. Performance feedback is given to reinforce progress and the exercises are designed to be enjoyable to complete, with titrated difficulty levels over time.
Group II: Facilitate tDCS + CRExperimental Treatment1 Intervention
Over the course of 8 weeks, for 5 days a week, participants designated a 'facilitator' will trained to deliver tDCS &CR at-home. tDCS will be administered during the 2 hour CR sessions for 30 min/day. The tDCS montage will be bifrontal91 with 1 large anode placed over Fz and the cathode over Iz. The direct current will be 2 mA (current density = 0.57 A/m2). CR sessions will utilize didactic and computerized drill-based exercises which focus on practice and repetition of neurocognitive ability areas that are affected in depression such as attention, processing speed, executive function, verbal memory, and working memory.
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Who is running the clinical trial?
Centre for Addiction and Mental HealthLead Sponsor
354 Previous Clinical Trials
81,080 Total Patients Enrolled
CAMH FoundationOTHER
2 Previous Clinical Trials
873 Total Patients Enrolled
Tarek Rajji, MDPrincipal InvestigatorCentre for Addiction and Mental Health
5 Previous Clinical Trials
581 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 60 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Facilitate tDCS + CR
- Group 2: Receive tDCS + CR
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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