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

Primary Purpose

Mild Cognitive Impairment, Major Depressive Disorder, Alzheimer's Dementia

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Receive tDCS+CR
Facilitate tDCS + CR
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mild Cognitive Impairment

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

MCI Group

Inclusion:

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

Exclusion:

  1. Met DSM-IV criteria for Major Depressive Episode in past 10 years
  2. Lifetime DSM-IV diagnosis of schizophrenia, bipolar disorder, or OCD
  3. DSM-IV diagnosis of alcohol or other substances use disorder within the past 12 months
  4. High risk for suicide
  5. Significant neurological condition (e.g., stroke, seizure disorder, MS)
  6. Unstable medical illness, (e.g., uncontrolled diabetes mellitus or hypertension)
  7. Having taken a cognitive enhancer (acetylcholinesterase inhibitor or memantine) within the past 6 weeks
  8. 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.
  9. A pace-maker or other metal implants that would preclude safe use of tDCS.

MDD Group

Inclusion:

  1. Age ≥ 60 (on day of randomization)
  2. Meets DSM-IV criteria for one or more MDE(s)with:

    1. 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

      OR

    2. 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).
  3. MADRS score of 10 or below
  4. Willingness to provide informed consent
  5. Availability of a study partner who has regular contact with the participant
  6. Ability to read and communicate in English (with corrected vision and hearing, if needed)

Exclusion:

  1. Meets DSM-IV criteria for Major Neurocognitive Disorder ("dementia")
  2. Lifetime DSM-IV diagnosis of schizophrenia, bipolar disorder, or OCD
  3. DSM-IV diagnosis of alcohol or other substances use disorder within the past 12 months.
  4. High risk for suicide.
  5. Significant neurological condition (e.g., stroke, seizure disorder, MS)
  6. Unstable medical illness (e.g., uncontrolled diabetes mellitus or hypertension)
  7. Participants taking anticonvulsants, and other psychotropic medication (see exception below) that cannot be safely tapered and discontinued. In addition to any antidepressant, 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, trazodone, or a benzodiazepine; and gabapentin or pregabalin if prescribed for chronic pain.
  8. Having taken a cognitive enhancer (acetylcholinesterase inhibitor or memantine) within the past 6 weeks.
  9. A pace-maker or other metal implants that would preclude safe use of tDCS.

Facilitator Group

Inclusion:

  1. Willingness to provide informed consent
  2. Ability to read and communicate in English (with corrected vision and hearing, if needed)

    Exclusion:

  3. Physical or medical illness that prevents participant from learning or administering CR + tDCS, as determined by the research team

Sites / Locations

  • Centre for Addiction and Mental Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Receive tDCS + CR

Facilitate tDCS + CR

Arm Description

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.

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.

Outcomes

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.
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

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 patients 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

Full Information

First Posted
November 2, 2016
Last Updated
February 14, 2023
Sponsor
Centre for Addiction and Mental Health
Collaborators
CAMH Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02959502
Brief Title
Home-Based CR and tDCS to Enhance Cognition in Persons With Mild Cognitive Impairment and Late Life Depression
Official Title
Home-Based Cognitive Remediation and Transcranial Direct Current Stimulation to Enhance Cognition in Persons With Mild Cognitive Impairment and Late Life Depression
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 31, 2016 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
CAMH Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Major Depressive Disorder, Alzheimer's Dementia, Transcranial Direct Current Stimulation, tDCS

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Receive tDCS + CR
Arm Type
Experimental
Arm Description
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.
Arm Title
Facilitate tDCS + CR
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Receive tDCS+CR
Other Intervention Name(s)
transcranial Direct Current Stimulation (tDCS), Cognitive Remediation (CR)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Facilitate tDCS + CR
Other Intervention Name(s)
transcranial Direct Current Stimulation (tDCS), Cognitive Remediation (CR)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Time Frame
Approximately 24 months after baseline
Title
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.
Description
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.
Time Frame
Baseline and approximately 24 months after baseline
Secondary Outcome Measure Information:
Title
Assess change in Quality of Life Scale scores among patients between baseline and at the end of the 8-week course.
Time Frame
Baseline and 8 weeks after baseline.
Title
Measure the change in Quality of Life Scale scores among facilitators between baseline and at the end of the 8-week course.
Time Frame
Baseline to 8 weeks after baseline.
Title
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
Time Frame
Baseline to 8 weeks after baseline.
Title
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
Time Frame
Baseline to 8 weeks after baseline.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
MCI Group Inclusion: 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) Exclusion: 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 Inclusion: 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 OR 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 Willingness to provide informed consent 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) Exclusion: Meets DSM-IV criteria for Major Neurocognitive Disorder ("dementia") 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) Participants taking anticonvulsants, and other psychotropic medication (see exception below) that cannot be safely tapered and discontinued. In addition to any antidepressant, 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, trazodone, or a benzodiazepine; and gabapentin or pregabalin if prescribed for chronic pain. Having taken a cognitive enhancer (acetylcholinesterase inhibitor or memantine) within the past 6 weeks. A pace-maker or other metal implants that would preclude safe use of tDCS. Facilitator Group Inclusion: Willingness to provide informed consent Ability to read and communicate in English (with corrected vision and hearing, if needed) Exclusion: Physical or medical illness that prevents participant from learning or administering CR + tDCS, as determined by the research team
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarek Rajji, MD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J 1H4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.camh.net/research
Description
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

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

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