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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 approximately 24 months after baseline
Awards & highlights

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~baseline and approximately 24 months after baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and approximately 24 months after baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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.

Trial 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.

Find a Location

Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor
366 Previous Clinical Trials
82,296 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

Facilitate tDCS + CR (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT02959502 — N/A
Mild Cognitive Impairment Research Study Groups: Receive tDCS + CR, Facilitate tDCS + CR
Mild Cognitive Impairment Clinical Trial 2023: Facilitate tDCS + CR Highlights & Side Effects. Trial Name: NCT02959502 — N/A
Facilitate tDCS + CR (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02959502 — N/A
~1 spots leftby Dec 2024
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