Home-Based CR and tDCS to Enhance Cognition in Persons With Mild Cognitive Impairment and Late Life Depression

Not Applicable

Active, not recruiting

• Conditions: Alzheimer's Dementia; Major Depressive Disorder; Transcranial Direct Current Stimulation; tDCS; Mild Cognitive Impairment

• Registration Number: NCT02959502
• Lead Sponsor: Centre for Addiction and Mental Health

Brief Summary

The overall goals of this project are to assess the feasibility and impact of designing and implementing an at-home intervention aimed at preventing long-term cognitive decline and improving cognition in individuals currently at-risk for developing AD.

Detailed Description

By the time Alzheimer's Dementia (AD) and related disorders are diagnosed, the brain has sustained substantial insult that limits the efficacy of current treatments. Preventive interventions are urgently needed but the majority of prevention studies require large numbers of participants, long follow-up periods, and frequent study visits. It is not feasible for many geriatric patients to attend clinics for treatment on a daily basis due to mobility and transportation restrictions, associated costs, and lack of rural clinic locations. Interventions delivered remotely, or administered within an individual's home, allow for preventative treatments to be made accessible to a wider range of individuals. Thus, the overall goals of this project are to assess the feasibility and impact of designing and implementing an at-home intervention aimed at preventing long-term cognitive decline and improving cognition in individuals currently at-risk for developing AD. These high-risk individuals that will be targeted in this proposal are: (1) older adults with Mild Cognitive Impairment (MCI), (2) older adults with Major Depressive Disorder (MDD), and (3) older adults with MCI and MDD.

The proposed intervention combines cognitive remediation (CR) and non-invasive brain stimulation - transcranial Direct Current Stimulation (tDCS), to be delivered in the participants' home environment. Twenty couples (40 participants) will be recruited, with one member defined as the "patient" and the second member defined as the "caregiver" to the patient. These caregivers will facilitate the delivery of the study intervention (i.e., CR+tDCS). Participants with a diagnosis of MCI or MDD or both, who have a caregiver, will receive open-label, active CR+tDCS over a period of 8 weeks. Both CR and tDCS have been shown to induce neuroplasticity and improve cognition. The aim of this pilot study is to assess the feasibility of delivering these combined interventions at home.

Study Timeline

• Study Start: 2016-10-31
• Study First Submitted: 2016-11-02
• Study First Submitted QC: 2016-11-07
• Study First Posted: 2016-11-09
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.	Approximately 24 months after 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.	Baseline and approximately 24 months after baseline	Compliance rate is defined as the the number of sessions completed as assessed by the Session Log divided by the total number of sessions across the induction phase and boosters.

Secondary Outcome Measures

Name	Time	Method
Measure the change in Quality of Life Scale scores among facilitators between baseline and at the end of the 8-week course.	Baseline to 8 weeks after baseline.
Assess change in Quality of Life Scale scores among patients between baseline and at the end of the 8-week course.	Baseline and 8 weeks after baseline.
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	Baseline to 8 weeks after baseline.
Measure the change in cognition (as indicated by a change in the Screen for Cognitive Impairment in Psychiatry) among patients between baseline and at the end of the 8-week course	Baseline to 8 weeks after baseline.

Trial Locations

Locations (1)

Centre for Addiction and Mental Health; 🇨🇦 Toronto, Ontario, Canada