Major Depressive DisorderNCT05976659
Home-based Neuromodulation to Target Depression And Memory Symptoms in Older Adults
A study testing Transcranial direct current stimulation (tDCS); Transcranial alternating current stimulation (tACS) in people with Major Depressive Disorder and Alzheimer Disease, run by Hebrew SeniorLife at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Major Depressive Disorder, Alzheimer Disease, Dementia
- What is being tested?
- Transcranial direct current stimulation (tDCS); Transcranial alternating current stimulation (tACS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Hinda and Arthur Marcus Institute for Aging Research
Boston, Massachusetts, 02131
Davide Balos Cappon, MS; PhD
Rachel Fox, BS, 617-971-5415, rachelfox@hsl.harvard.edu
About this study
Official title: Targeting Depression And Memory Symptoms With Multi-Focal Circuit-Based Neuromodulation
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.
Read the 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).
- Conditions
- Major Depressive Disorder, Alzheimer Disease, Dementia, Nervous System Diseases, Memory Disorders, Depressive Disorder
- Being tested
- Transcranial direct current stimulation (tDCS); Transcranial alternating current stimulation (tACS)
- Keywords
- Major Depressive Disorder, Alzheimer's Disease, Transcranial Direct Current Stimulation, Transcranial Alternating Current Stimulation, Memory, Brain Stimulation
- Medical subject headings
- Depressive Disorder, Major, Alzheimer Disease, Dementia, Nervous System Diseases, Memory Disorders, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulation (tDCS); Transcranial alternating current stimulation (tACS)Device
Also called Transcranial electrical stimulation (tES)
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.
| Study group | Role | What they receive |
|---|---|---|
| tDCS prefrontal cortex + tASC angular gyrus in MDD in the context of AD | Experimental | 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. Receives: Device: Transcranial direct current stimulation (tDCS); Transcranial alternating current stimulation (tACS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geriatric Depression Scale-15 Items (GDS-15)
This questionnaire is designed to evaluate depression in older adults.
Measured: Change from Baseline GDS-15 total score at immediate post-intervention follow-up
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.
Measured: Change from Baseline RAVLT Total Recall total score at immediate post-intervention follow-up
Secondary outcomes (20)
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.
Measured: Change from Baseline CSDD total score at immediate post-intervention follow-up
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.
Measured: Change from Baseline CSDD total score at 3 months follow-up
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.
Measured: Change from Baseline CES-D at immediate post-intervention follow-up
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.
Measured: Change from Baseline CES-D at 3 month follow-up
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.
Measured: Change from Baseline MoCA at immediate post-intervention follow-up
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.
Measured: Change from Baseline MoCA at 3 month follow up
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.
Measured: Change from Baseline Digit Span (Forward and Backward) at immediate post-intervention follow-up
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.
Measured: Change from Baseline Digit Span (Forward and Backward) at 3 month follow-up
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.
Measured: Change from Baseline Trail making test A and B at immediate post-intervention follow-up
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.
Measured: Change from Baseline Trail making test A and B at 3 month follow-up
Category and Phonemic Fluency Test
Test of semantic knowledge and word retrieval.
Measured: Change from Baseline in Category and Phonemic Fluency Test at immediate post-intervention follow-up
Category and Phonemic Fluency Test
Test of semantic knowledge and word retrieval.
Measured: Change from Baseline in Category and Phonemic Fluency Test at 3 month 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.
Measured: Change from Baseline FAQ at immediate post-intervention 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.
Measured: Change from Baseline FAQ at 3 month 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.
Measured: Change from Baseline DEMQOL at immediate post-intervention 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.
Measured: Change from Baseline DEMQOL at 3 month follow-up
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.
Measured: Change from Baseline ASRM at immediate post-intervention follow-up
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.
Measured: Change from Baseline ASRM at 3 month follow-up
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.
Measured: Change from Baseline RAVLT Total Recall total score at 3 months follow-up
Geriatric Depression Scale-15 Items (GDS-15)
This questionnaire is designed to evaluate depression in older adults.
Measured: Change from Baseline GDS-15 total score at 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start24 Jan 2023
- Primary completion31 Jan 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebrew SeniorLife
- Sponsor type
- University, hospital or other
- Collaborators
- Brain & Behavior Research Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05976659
- Sponsor's protocol ID
- 30772
- Status last verified
- Mar 2023
- First submitted
- 14 Jun 2023
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The prospective plan is to have data available in a data dementia-related data repository.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Depression And Memory Symptoms With Multi-Focal Circuit-Based Neuromodulation
- ClinicalTrials.gov ID
- NCT05976659
- Acronym / sponsor ID
- 30772
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hebrew SeniorLifeUniversity, hospital or other
- Collaborators
- Brain & Behavior Research Foundation
- Study start
- 24 Jan 2023 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tDCS prefrontal cortex + tASC angular gyrus in MDD in the context of AD | Experimental | Device: Transcranial direct current stimulation (tDCS); Transcranial alternating current stimulation (tACS)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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial direct current stimulation (tDCS); Transcranial alternating current stimulation (tACS)Also: Transcranial electrical stimulation (tES)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. | Device | tDCS prefrontal cortex + tASC angular gyrus in MDD in the context of AD |
Primary outcome
Geriatric Depression Scale-15 Items (GDS-15)
Time frame: Change from Baseline GDS-15 total score at immediate post-intervention follow-up
This questionnaire is designed to evaluate depression in older adults.
Rey Auditory Verbal Learning Test (RAVLT) Total Recall
Time frame: Change from Baseline RAVLT Total Recall total score at immediate post-intervention follow-up
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.
20 secondary outcomes
Cornell Scale for Depression in Dementia (CSDD)
Time frame: Change from Baseline CSDD total score at immediate post-intervention follow-up
Cornell Scale for Depression in Dementia (CSDD)
Time frame: Change from Baseline CSDD total score at 3 months follow-up
The Center for Epidemiological Studies-Depression (CES-D)
Time frame: Change from Baseline CES-D at immediate post-intervention follow-up
The Center for Epidemiological Studies-Depression (CES-D)
Time frame: Change from Baseline CES-D at 3 month follow-up
Montreal Cognitive Assessment (MoCA) total score, memory and executive subscores
Time frame: Change from Baseline MoCA at immediate post-intervention follow-up
Montreal Cognitive Assessment (MoCA) total score, memory and executive subscores
Time frame: Change from Baseline MoCA at 3 month follow up
Digit Span (Forward and Backward)
Time frame: Change from Baseline Digit Span (Forward and Backward) at immediate post-intervention follow-up
Digit Span (Forward and Backward)
Time frame: Change from Baseline Digit Span (Forward and Backward) at 3 month follow-up
Trail making test A and B
Time frame: Change from Baseline Trail making test A and B at immediate post-intervention follow-up
Trail making test A and B
Time frame: Change from Baseline Trail making test A and B at 3 month follow-up
Category and Phonemic Fluency Test
Time frame: Change from Baseline in Category and Phonemic Fluency Test at immediate post-intervention follow-up
Category and Phonemic Fluency Test
Time frame: Change from Baseline in Category and Phonemic Fluency Test at 3 month follow-up
Functional Activity Questionnaire (FAQ)
Time frame: Change from Baseline FAQ at immediate post-intervention follow-up
Functional Activity Questionnaire (FAQ)
Time frame: Change from Baseline FAQ at 3 month follow-up
Dementia Quality of Life Questionnaire (DEMQOL)
Time frame: Change from Baseline DEMQOL at immediate post-intervention follow-up
Dementia Quality of Life Questionnaire (DEMQOL)
Time frame: Change from Baseline DEMQOL at 3 month follow-up
Altman Self-Rating Mania Scale (ASRM)
Time frame: Change from Baseline ASRM at immediate post-intervention follow-up
Altman Self-Rating Mania Scale (ASRM)
Time frame: Change from Baseline ASRM at 3 month follow-up
Rey Auditory Verbal Learning Test (RAVLT) Total Recall
Time frame: Change from Baseline RAVLT Total Recall total score at 3 months follow-up
Geriatric Depression Scale-15 Items (GDS-15)
Time frame: Change from Baseline GDS-15 total score at 3 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Individual participant dataSharing planned: Yes. The prospective plan is to have data available in a data dementia-related data repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation (tDCS); Transcranial alternating current stimulation (tACS) in people with Major Depressive Disorder and Alzheimer Disease, run by Hebrew SeniorLife at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HomeStim Study (617-971-5415, MoodMemStim@hsl.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geriatric Depression Scale-15 Items (GDS-15) (time frame: Change from Baseline GDS-15 total score at immediate post-intervention follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.