NCT02959502

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

Home-Based Cognitive Remediation and Transcranial Direct Current Stimulation to Enhance Cognition in Persons With Mild Cognitive Impairment and Late Life Depression

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Centre for Addiction and Mental Health · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	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.
OTHER	Facilitate tDCS + CR	Over the course of 8 weeks, for 5 days a week, participants designated a 'facilitator' will be 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.

Timeline

• Start date: 2016-10-31
• Primary completion: 2023-03-23
• Completion: 2026-12-01
• First posted: 2016-11-09
• Last updated: 2026-04-13

Locations

1 site across 1 country: Canada