Back to resultsHome-based Neuromodulation to Target Depression And Memory Symptoms in Older Adults
Primary Purpose
Major Depressive Disorder, Alzheimer Disease, Dementia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial direct current stimulation (tDCS); Transcranial alternating current stimulation (tACS)
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depressive Disorder, Alzheimer's Disease, Transcranial Direct Current Stimulation, Transcranial Alternating Current Stimulation, Memory, Brain Stimulation
Eligibility Criteria
Inclusion Criteria: Participants (Ps) willing and capable to give informed consent for the participation in the study after it has been thoroughly explained able and willing to comply with all study requirements an informed consent form was signed able to read, write, and communicate in English able to identify an eligible administrator to participate with them in the study Caregiver/Administrators (As) at least 21 years of age able to read, write, and communicate in English self-reported computer proficiency and willingness to learn how to use tES as defined by "yes" answers to the questions "Do you feel comfortable using a computer?" and "Are you willing to be the primary caregiver for a participant and learn how to administer tES?" stated availability during weekdays throughout the study period to administer tES to the participant Exclusion Criteria: contraindications to tES, as recorded on a standardized screening questionnaire, which include a reported seizure within the past two years, use of neuroactive drugs, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant, etc.) the presence of any active dermatological condition, such as eczema, on the scalp a score of 18 or less on the Montreal Cognitive Assessment (MoCA) during the in-person screen blindness or other disabilities that prevent task performance an inability to understand study procedures following review of the Informed Consent form Understanding will be assessed by asking the participant to answer the following three questions: 1) What is the purpose of this study? 2) What are the risks of study involvement? 3) If you decide to participate, are you allowed to withdraw from the study at any time? Answers will be recorded by study personnel on the "Assessment of Protocol Understanding" form. Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator Caregiver/Administrators (As) mild cognitive impairment defined by a MoCA score ≤26 during the in-person screen insufficient understanding of study procedures following review of the Informed Consent form Understanding will be assessed by asking the participant to answer the following three questions: 1) What is the purpose of this study? 2) What are the risks of study involvement? 3) If you decide to participate, are you allowed to withdraw from the study at any time? Answers will be recorded by study personnel on the "Assessment of Protocol Understanding" form. Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator. poor eyesight, severe arthritis in the hands, pain, deformity or other condition that interferes with successful administration of tES
Sites / Locations
- Hinda and Arthur Marcus Institute for Aging ResearchRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
tDCS prefrontal cortex + tASC angular gyrus in MDD in the context of AD
Arm Description
Participants will undergo 20 sessions of home-based tDCS over the prefrontal cortex and tACS over the left angular gyrus.These sessions will take place five times a week for four weeks, with one daily stimulation session of no more than 20 minutes. The participant's home will be the setting for the completion of the brain stimulation intervention, which will be delivered by trained caregivers/study companions/administrators.
Outcomes
Primary Outcome Measures
Geriatric Depression Scale-15 Items (GDS-15)
This questionnaire is designed to evaluate depression in older adults.
Rey Auditory Verbal Learning Test (RAVLT) Total Recall
This test is designed to evaluate verbal memory in those 16 years of age and older. It can be used to evaluate the nature and severity of memory dysfunction and to track changes in memory function over time.
Secondary Outcome Measures
Cornell Scale for Depression in Dementia (CSDD)
This scale measures signs and symptoms of major depression in demented patients. Scores range from 0 to 38, with higher scores indicating higher level of depression.
Cornell Scale for Depression in Dementia (CSDD)
This scale measures signs and symptoms of major depression in demented patients. Scores range from 0 to 38, with higher scores indicating higher level of depression.
The Center for Epidemiological Studies-Depression (CES-D)
This scale is designed to measure self-reported symptoms associated with depression. Scores range from 0 to 60, with higher scores indicating worse outcome.
The Center for Epidemiological Studies-Depression (CES-D)
This scale is designed to measure self-reported symptoms associated with depression. Scores range from 0 to 60, with higher scores indicating worse outcome.
Montreal Cognitive Assessment (MoCA) total score, memory and executive subscores
A composite assessment tool that measures functionality of multiple cognitive domains. Scores range from 0 to 30, with higher scores indicating a better outcome.
Montreal Cognitive Assessment (MoCA) total score, memory and executive subscores
A composite assessment tool that measures functionality of multiple cognitive domains. Scores range from 0 to 30, with higher scores indicating a better outcome.
Digit Span (Forward and Backward)
A digit-span forward and backward task measures auditory registration, basic span of attention and working memory storage capacity of numbers. Participants are auditorily presented with a chain of numerical digits and are instructed to repeat the sequence of numbers verbally in the order that it was presented or in backwards order. The length of the sequence increases with each correct trial completion. The more numbers repeated the better a participants has done.
Digit Span (Forward and Backward)
A digit-span forward and backward task measures auditory registration, basic span of attention and working memory storage capacity of numbers. Participants are auditorily presented with a chain of numerical digits and are instructed to repeat the sequence of numbers verbally in the order that it was presented or in backwards order. The length of the sequence increases with each correct trial completion. The more numbers repeated the better a participants has done.
Trail making test A and B
This test assess aspects of executive function such as psychomotor processing speed, visual search, cognitive flexibility, set shifting, multitasking.
Trail making test A and B
This test assess aspects of executive function such as psychomotor processing speed, visual search, cognitive flexibility, set shifting, multitasking.
Category and Phonemic Fluency Test
Test of semantic knowledge and word retrieval.
Category and Phonemic Fluency Test
Test of semantic knowledge and word retrieval.
Functional Activity Questionnaire (FAQ)
This is a 10-item scale to measure functional status via independent activities of daily living. Each item is a functional activity, and the caregiver/informant rates the participant's ability using the following scoring system:
Dependent = 3 Requires assistance = 2 Has difficulty but does by self = 1 Normal = 0 Never did [the activity] but could do now = 0 Never did and would have difficulty now = 1 The scores are summed (range 0-30). Cut-point of 9 (dependent in 3 or more activities) is recommended to indicate impaired function and possible cognitive impairment. This test will be used to track functional status over the course of the intervention and follow-up.
Functional Activity Questionnaire (FAQ)
This is a 10-item scale to measure functional status via independent activities of daily living. Each item is a functional activity, and the caregiver/informant rates the participant's ability using the following scoring system:
Dependent = 3 Requires assistance = 2 Has difficulty but does by self = 1 Normal = 0 Never did [the activity] but could do now = 0 Never did and would have difficulty now = 1 The scores are summed (range 0-30). Cut-point of 9 (dependent in 3 or more activities) is recommended to indicate impaired function and possible cognitive impairment. This test will be used to track functional status over the course of the intervention and follow-up.
Dementia Quality of Life Questionnaire (DEMQOL)
A questionnaire that is designed to assess the quality of life of a patient with dementia. Scores range from 28 to 112, where higher scores indicate better health-related quality of life.
Dementia Quality of Life Questionnaire (DEMQOL)
A questionnaire that is designed to assess the quality of life of a patient with dementia. Scores range from 28 to 112, where higher scores indicate better health-related quality of life.
Altman Self-Rating Mania Scale (ASRM)
Screening instrument used to detect early warning signs of impending mania. Scores range from 0 to 20, with higher scores indicating worse outcome.
Altman Self-Rating Mania Scale (ASRM)
Screening instrument used to detect early warning signs of impending mania. Scores range from 0 to 20, with higher scores indicating worse outcome.
Rey Auditory Verbal Learning Test (RAVLT) Total Recall
This test is designed to evaluate verbal memory in those 16 years of age and older. It can be used to evaluate the nature and severity of memory dysfunction and to track changes in memory function over time.
Geriatric Depression Scale-15 Items (GDS-15)
This questionnaire is designed to evaluate depression in older adults.
Full Information
NCT ID
NCT05976659
First Posted
June 14, 2023
Last Updated
July 27, 2023
Sponsor
Hebrew SeniorLife
Collaborators
Brain & Behavior Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05976659
Brief Title
Home-based Neuromodulation to Target Depression And Memory Symptoms in Older Adults
Official Title
Targeting Depression And Memory Symptoms With Multi-Focal Circuit-Based Neuromodulation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 24, 2023 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hebrew SeniorLife
Collaborators
Brain & Behavior Research Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This project aims to explore the feasibility and effects of a symptom-specific, brain-circuit-based, home-based neuromodulation therapy for addressing mood and memory symptoms in older adults with major depressive disorder (MDD) in the context of dementia.
Detailed Description
This is a single arm pilot study to determine safety, feasibility, and preliminary efficacy of a home-based brain stimulation intervention of transcranial direct current stimulation (tDCS) targeting the prefrontal cortex, and transcranial alternating stimulation (tACS) targeting the angular gyrus to improve depressive and episodic memory symptoms in individuals with major depressive disorder (MDD) in the context of dementia. Participants will take part in a series of pre-intervention assessments, the brain stimulation intervention consisting of 20 once-daily 20-minute stimulation sessions given over a period of 4 weeks, and a series of post-intervention assessments (taken immediately after brain stimulation and 3 months after stimulation).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Alzheimer Disease, Dementia, Nervous System Diseases, Memory Disorders, Depressive Disorder
Keywords
Major Depressive Disorder, Alzheimer's Disease, Transcranial Direct Current Stimulation, Transcranial Alternating Current Stimulation, Memory, Brain Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
tDCS prefrontal cortex + tASC angular gyrus in MDD in the context of AD
Arm Type
Experimental
Arm Description
Participants will undergo 20 sessions of home-based tDCS over the prefrontal cortex and tACS over the left angular gyrus.These sessions will take place five times a week for four weeks, with one daily stimulation session of no more than 20 minutes. The participant's home will be the setting for the completion of the brain stimulation intervention, which will be delivered by trained caregivers/study companions/administrators.
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation (tDCS); Transcranial alternating current stimulation (tACS)
Other Intervention Name(s)
Transcranial electrical stimulation (tES)
Intervention Description
Transcranial electrical stimulation (tES), via direct and alternating current, will be administered to the participants in their home by trained caregivers/study companions administrators. All training and intervention sessions will take place in the participant's home.
Primary Outcome Measure Information:
Title
Geriatric Depression Scale-15 Items (GDS-15)
Description
This questionnaire is designed to evaluate depression in older adults.
Time Frame
Change from Baseline GDS-15 total score at immediate post-intervention follow-up
Title
Rey Auditory Verbal Learning Test (RAVLT) Total Recall
Description
This test is designed to evaluate verbal memory in those 16 years of age and older. It can be used to evaluate the nature and severity of memory dysfunction and to track changes in memory function over time.
Time Frame
Change from Baseline RAVLT Total Recall total score at immediate post-intervention follow-up
Secondary Outcome Measure Information:
Title
Cornell Scale for Depression in Dementia (CSDD)
Description
This scale measures signs and symptoms of major depression in demented patients. Scores range from 0 to 38, with higher scores indicating higher level of depression.
Time Frame
Change from Baseline CSDD total score at immediate post-intervention follow-up
Title
Cornell Scale for Depression in Dementia (CSDD)
Description
This scale measures signs and symptoms of major depression in demented patients. Scores range from 0 to 38, with higher scores indicating higher level of depression.
Time Frame
Change from Baseline CSDD total score at 3 months follow-up
Title
The Center for Epidemiological Studies-Depression (CES-D)
Description
This scale is designed to measure self-reported symptoms associated with depression. Scores range from 0 to 60, with higher scores indicating worse outcome.
Time Frame
Change from Baseline CES-D at immediate post-intervention follow-up
Title
The Center for Epidemiological Studies-Depression (CES-D)
Description
This scale is designed to measure self-reported symptoms associated with depression. Scores range from 0 to 60, with higher scores indicating worse outcome.
Time Frame
Change from Baseline CES-D at 3 month follow-up
Title
Montreal Cognitive Assessment (MoCA) total score, memory and executive subscores
Description
A composite assessment tool that measures functionality of multiple cognitive domains. Scores range from 0 to 30, with higher scores indicating a better outcome.
Time Frame
Change from Baseline MoCA at immediate post-intervention follow-up
Title
Montreal Cognitive Assessment (MoCA) total score, memory and executive subscores
Description
A composite assessment tool that measures functionality of multiple cognitive domains. Scores range from 0 to 30, with higher scores indicating a better outcome.
Time Frame
Change from Baseline MoCA at 3 month follow up
Title
Digit Span (Forward and Backward)
Description
A digit-span forward and backward task measures auditory registration, basic span of attention and working memory storage capacity of numbers. Participants are auditorily presented with a chain of numerical digits and are instructed to repeat the sequence of numbers verbally in the order that it was presented or in backwards order. The length of the sequence increases with each correct trial completion. The more numbers repeated the better a participants has done.
Time Frame
Change from Baseline Digit Span (Forward and Backward) at immediate post-intervention follow-up
Title
Digit Span (Forward and Backward)
Description
A digit-span forward and backward task measures auditory registration, basic span of attention and working memory storage capacity of numbers. Participants are auditorily presented with a chain of numerical digits and are instructed to repeat the sequence of numbers verbally in the order that it was presented or in backwards order. The length of the sequence increases with each correct trial completion. The more numbers repeated the better a participants has done.
Time Frame
Change from Baseline Digit Span (Forward and Backward) at 3 month follow-up
Title
Trail making test A and B
Description
This test assess aspects of executive function such as psychomotor processing speed, visual search, cognitive flexibility, set shifting, multitasking.
Time Frame
Change from Baseline Trail making test A and B at immediate post-intervention follow-up
Title
Trail making test A and B
Description
This test assess aspects of executive function such as psychomotor processing speed, visual search, cognitive flexibility, set shifting, multitasking.
Time Frame
Change from Baseline Trail making test A and B at 3 month follow-up
Title
Category and Phonemic Fluency Test
Description
Test of semantic knowledge and word retrieval.
Time Frame
Change from Baseline in Category and Phonemic Fluency Test at immediate post-intervention follow-up
Title
Category and Phonemic Fluency Test
Description
Test of semantic knowledge and word retrieval.
Time Frame
Change from Baseline in Category and Phonemic Fluency Test at 3 month follow-up
Title
Functional Activity Questionnaire (FAQ)
Description
This is a 10-item scale to measure functional status via independent activities of daily living. Each item is a functional activity, and the caregiver/informant rates the participant's ability using the following scoring system:
Dependent = 3 Requires assistance = 2 Has difficulty but does by self = 1 Normal = 0 Never did [the activity] but could do now = 0 Never did and would have difficulty now = 1 The scores are summed (range 0-30). Cut-point of 9 (dependent in 3 or more activities) is recommended to indicate impaired function and possible cognitive impairment. This test will be used to track functional status over the course of the intervention and follow-up.
Time Frame
Change from Baseline FAQ at immediate post-intervention follow-up
Title
Functional Activity Questionnaire (FAQ)
Description
This is a 10-item scale to measure functional status via independent activities of daily living. Each item is a functional activity, and the caregiver/informant rates the participant's ability using the following scoring system:
Dependent = 3 Requires assistance = 2 Has difficulty but does by self = 1 Normal = 0 Never did [the activity] but could do now = 0 Never did and would have difficulty now = 1 The scores are summed (range 0-30). Cut-point of 9 (dependent in 3 or more activities) is recommended to indicate impaired function and possible cognitive impairment. This test will be used to track functional status over the course of the intervention and follow-up.
Time Frame
Change from Baseline FAQ at 3 month follow-up
Title
Dementia Quality of Life Questionnaire (DEMQOL)
Description
A questionnaire that is designed to assess the quality of life of a patient with dementia. Scores range from 28 to 112, where higher scores indicate better health-related quality of life.
Time Frame
Change from Baseline DEMQOL at immediate post-intervention follow-up
Title
Dementia Quality of Life Questionnaire (DEMQOL)
Description
A questionnaire that is designed to assess the quality of life of a patient with dementia. Scores range from 28 to 112, where higher scores indicate better health-related quality of life.
Time Frame
Change from Baseline DEMQOL at 3 month follow-up
Title
Altman Self-Rating Mania Scale (ASRM)
Description
Screening instrument used to detect early warning signs of impending mania. Scores range from 0 to 20, with higher scores indicating worse outcome.
Time Frame
Change from Baseline ASRM at immediate post-intervention follow-up
Title
Altman Self-Rating Mania Scale (ASRM)
Description
Screening instrument used to detect early warning signs of impending mania. Scores range from 0 to 20, with higher scores indicating worse outcome.
Time Frame
Change from Baseline ASRM at 3 month follow-up
Title
Rey Auditory Verbal Learning Test (RAVLT) Total Recall
Description
This test is designed to evaluate verbal memory in those 16 years of age and older. It can be used to evaluate the nature and severity of memory dysfunction and to track changes in memory function over time.
Time Frame
Change from Baseline RAVLT Total Recall total score at 3 months follow-up
Title
Geriatric Depression Scale-15 Items (GDS-15)
Description
This questionnaire is designed to evaluate depression in older adults.
Time Frame
Change from Baseline GDS-15 total score at 3 months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants (Ps)
willing and capable to give informed consent for the participation in the study after it has been thoroughly explained
able and willing to comply with all study requirements
an informed consent form was signed
able to read, write, and communicate in English
able to identify an eligible administrator to participate with them in the study Caregiver/Administrators (As)
at least 21 years of age
able to read, write, and communicate in English
self-reported computer proficiency and willingness to learn how to use tES as defined by "yes" answers to the questions "Do you feel comfortable using a computer?" and "Are you willing to be the primary caregiver for a participant and learn how to administer tES?"
stated availability during weekdays throughout the study period to administer tES to the participant
Exclusion Criteria:
contraindications to tES, as recorded on a standardized screening questionnaire, which include a reported seizure within the past two years, use of neuroactive drugs, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant, etc.)
the presence of any active dermatological condition, such as eczema, on the scalp a score of 18 or less on the Montreal Cognitive Assessment (MoCA) during the in-person screen
blindness or other disabilities that prevent task performance
an inability to understand study procedures following review of the Informed Consent form
Understanding will be assessed by asking the participant to answer the following three questions: 1) What is the purpose of this study? 2) What are the risks of study involvement? 3) If you decide to participate, are you allowed to withdraw from the study at any time? Answers will be recorded by study personnel on the "Assessment of Protocol Understanding" form. Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator Caregiver/Administrators (As)
mild cognitive impairment defined by a MoCA score ≤26 during the in-person screen
insufficient understanding of study procedures following review of the Informed Consent form Understanding will be assessed by asking the participant to answer the following three questions: 1) What is the purpose of this study? 2) What are the risks of study involvement? 3) If you decide to participate, are you allowed to withdraw from the study at any time? Answers will be recorded by study personnel on the "Assessment of Protocol Understanding" form. Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator.
poor eyesight, severe arthritis in the hands, pain, deformity or other condition that interferes with successful administration of tES
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
HomeStim Study
Phone
617-971-5415
Email
MoodMemStim@hsl.harvard.edu
Facility Information:
Facility Name
Hinda and Arthur Marcus Institute for Aging Research
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Davide Balos Cappon, MS; PhD
First Name & Middle Initial & Last Name & Degree
Rachel Fox, BS
Phone
617-971-5415
Email
rachelfox@hsl.harvard.edu
First Name & Middle Initial & Last Name & Degree
Davide Balos Cappon, MS; PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The prospective plan is to have data available in a data dementia-related data repository.
IPD Sharing Time Frame
The data will be available at the end of the study.
IPD Sharing Access Criteria
Depending on the repositories in which the data is held. However, use of the data will be restricted by permission and appropriate human subjects review of the prospective project.
Learn more about this trial
Home-based Neuromodulation to Target Depression And Memory Symptoms in Older Adults
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