Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-03-07 @ 10:50 PM
Study NCT ID:
NCT02959502
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-24
First Post:
2016-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Home-Based CR and tDCS to Enhance Cognition in Persons With Mild Cognitive Impairment and Late Life Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}, {'id': 'D000072466', 'term': 'Cognitive Remediation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2016-11-02', 'studyFirstSubmitQcDate': '2016-11-07', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.', 'timeFrame': 'Approximately 24 months after baseline'}, {'measure': '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.', 'timeFrame': 'Baseline and approximately 24 months after baseline', '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.'}], 'secondaryOutcomes': [{'measure': 'Assess change in Quality of Life Scale scores among patients between baseline and at the end of the 8-week course.', 'timeFrame': 'Baseline and 8 weeks after baseline.'}, {'measure': 'Measure the change in Quality of Life Scale scores among facilitators between baseline and at the end of the 8-week course.', 'timeFrame': 'Baseline to 8 weeks after baseline.'}, {'measure': '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', 'timeFrame': 'Baseline to 8 weeks after baseline.'}, {'measure': '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', 'timeFrame': 'Baseline to 8 weeks after baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Mild Cognitive Impairment', 'Major Depressive Disorder', "Alzheimer's Dementia", 'Transcranial Direct Current Stimulation', 'tDCS']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.camh.net/research', 'label': "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"}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'MCI Group\n\nInclusion:\n\n1. Age \\> 60 (on day of randomization)\n2. DSM-IV criteria for Mild Neurocognitive Disorder ("MCI")\n3. Willingness to provide informed consent\n4. MADRS score of 10 or below\n5. Availability of a study partner who has regular contact with the participant\n6. Ability to read and communicate in English (with corrected vision and hearing, if needed)\n\nExclusion:\n\n1. Met DSM-IV criteria for Major Depressive Episode in past 10 years\n2. Lifetime DSM-IV diagnosis of schizophrenia, bipolar disorder, or OCD\n3. DSM-IV diagnosis of alcohol or other substances use disorder within the past 12 months\n4. High risk for suicide\n5. Significant neurological condition (e.g., stroke, seizure disorder, MS)\n6. Unstable medical illness, (e.g., uncontrolled diabetes mellitus or hypertension)\n7. Having taken a cognitive enhancer (acetylcholinesterase inhibitor or memantine) within the past 6 weeks\n8. 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.\n9. A pace-maker or other metal implants that would preclude safe use of tDCS.\n\nMDD Group\n\nInclusion:\n\n1. Age ≥ 60 (on day of randomization)\n2. Meets DSM-IV criteria for one or more MDE(s)with:\n\n 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\n\n OR\n 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).\n3. MADRS score of 10 or below\n4. Willingness to provide informed consent\n5. Availability of a study partner who has regular contact with the participant\n6. Ability to read and communicate in English (with corrected vision and hearing, if needed)\n\nExclusion:\n\n1. Meets DSM-IV criteria for Major Neurocognitive Disorder ("dementia")\n2. Lifetime DSM-IV diagnosis of schizophrenia, bipolar disorder, or OCD\n3. DSM-IV diagnosis of alcohol or other substances use disorder within the past 12 months.\n4. High risk for suicide.\n5. Significant neurological condition (e.g., stroke, seizure disorder, MS)\n6. Unstable medical illness (e.g., uncontrolled diabetes mellitus or hypertension)\n7. 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.\n8. Having taken a cognitive enhancer (acetylcholinesterase inhibitor or memantine) within the past 6 weeks.\n9. A pace-maker or other metal implants that would preclude safe use of tDCS.\n\nFacilitator Group\n\nInclusion:\n\n1. Willingness to provide informed consent\n2. Ability to read and communicate in English (with corrected vision and hearing, if needed)\n\n Exclusion:\n3. Physical or medical illness that prevents participant from learning or administering CR + tDCS, as determined by the research team'}, 'identificationModule': {'nctId': 'NCT02959502', 'briefTitle': 'Home-Based CR and tDCS to Enhance Cognition in Persons With Mild Cognitive Impairment and Late Life Depression', 'organization': {'class': 'OTHER', 'fullName': 'Centre for Addiction and Mental Health'}, 'officialTitle': 'Home-Based Cognitive Remediation and Transcranial Direct Current Stimulation to Enhance Cognition in Persons With Mild Cognitive Impairment and Late Life Depression', 'orgStudyIdInfo': {'id': '069/2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Receive tDCS + CR', '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.", 'interventionNames': ['Other: Receive tDCS+CR']}, {'type': 'EXPERIMENTAL', 'label': 'Facilitate tDCS + CR', '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.", 'interventionNames': ['Other: Facilitate tDCS + CR']}], 'interventions': [{'name': 'Receive tDCS+CR', 'type': 'OTHER', 'otherNames': ['transcranial Direct Current Stimulation (tDCS)', 'Cognitive Remediation (CR)'], '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.", 'armGroupLabels': ['Receive tDCS + CR']}, {'name': 'Facilitate tDCS + CR', 'type': 'OTHER', 'otherNames': ['transcranial Direct Current Stimulation (tDCS)', 'Cognitive Remediation (CR)'], '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.", 'armGroupLabels': ['Facilitate tDCS + CR']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M6J 1H4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Centre for Addiction and Mental Health', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Tarek Rajji, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Addiction and Mental Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre for Addiction and Mental Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'CAMH Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Geriatric Psychiatry', 'investigatorFullName': 'Tarek Rajji', 'investigatorAffiliation': 'Centre for Addiction and Mental Health'}}}}