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

NCT02959502 | Active Not Recruiting

• 1 other identifier: 069/2016
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline and approximately 24 months after baseline

Secondary Outcomes (4)

• 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 Quality of Life Scale scores 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.

• 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.

Study Arms (2)

Receive tDCS + CR

EXPERIMENTAL

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: Receive tDCS+CR

Facilitate tDCS + CR

EXPERIMENTAL

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.

Other: Facilitate tDCS + CR

Interventions

Receive tDCS+CR OTHER

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.

Also known as: transcranial Direct Current Stimulation (tDCS), Cognitive Remediation (CR)

Receive tDCS + CR

Facilitate tDCS + CR OTHER

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.

Also known as: transcranial Direct Current Stimulation (tDCS), Cognitive Remediation (CR)

Facilitate tDCS + CR

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 60 (on day of randomization)
• DSM-IV criteria for Mild Neurocognitive Disorder ("MCI")
• Willingness to provide informed consent
• MADRS score of 10 or below
• Availability of a study partner who has regular contact with the participant
• Ability to read and communicate in English (with corrected vision and hearing, if needed)

You may not qualify if:

• Met DSM-IV criteria for Major Depressive Episode in past 10 years
• Lifetime DSM-IV diagnosis of schizophrenia, bipolar disorder, or OCD
• DSM-IV diagnosis of alcohol or other substances use disorder within the past 12 months
• High risk for suicide
• Significant neurological condition (e.g., stroke, seizure disorder, MS)
• Unstable medical illness, (e.g., uncontrolled diabetes mellitus or hypertension)
• Having taken a cognitive enhancer (acetylcholinesterase inhibitor or memantine) within the past 6 weeks
• Participants taking anticonvulsants, and other psychotropic medication (see exception below) that cannot be safely tapered and discontinued. The following psychotropic medications are allowed if they have been taken at a stable dose for at least 4 weeks prior to study entry: zopiclone, trazadone, or a benzodiazepine; gabapentin, pregabalin, duloxetine, venlafaxine, or low-dose tricyclic antidepressants if prescribed for chronic pain.
• A pace-maker or other metal implants that would preclude safe use of tDCS.
• MDD Group
• Age ≥ 60 (on day of randomization)
• Meets DSM-IV criteria for one or more MDE(s)with:
• an offset of 2 months to 5 years from the screening visit date. It is not necessary for this (these) episode(s) to have received medical attention
• an offset of 5 years or more from the screening visit date. It is necessary that at least one MDE received medical attention (e.g., previously been on one or more antidepressant(s), saw a psychiatrist, primary care physician, or had a previous hospitalization). Also, the MDE must have occurred during the participant's adult life (i.e., at 18 years of age or older).
• MADRS score of 10 or below

Sponsors & Collaborators

• CAMH Foundation: collaborator
• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

Location

Related Links

• Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital, fully affiliated with the University of Toronto, and a PAHO/WHO Collaborating Centre

MeSH Terms

Conditions

Cognitive Dysfunction; Depressive Disorder, Major; Alzheimer Disease

Interventions

Transcranial Direct Current Stimulation; Cognitive Remediation

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Depressive Disorder; Mood Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Behavior Therapy; Psychotherapy

Study Officials

• Tarek Rajji, MD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Geriatric Psychiatry

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: November 9, 2016
• Study Start: October 31, 2016
• Primary Completion: March 23, 2023
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)