Home-Based CR and tDCS to Enhance Cognition in Persons With Mild Cognitive Impairment and Late Life Depression
Mild Cognitive Impairment, Major Depressive Disorder, Alzheimer's Dementia
About this trial
This is an interventional other trial for Mild Cognitive Impairment
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
Sites / Locations
- Centre for Addiction and Mental Health
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Receive tDCS + CR
Facilitate tDCS + CR
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.