Clinical trial NCT05976659: 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
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Hebrew SeniorLife
Sponsor class: OTHER
Collaborators: name: Brain & Behavior Research Foundation
First posted: 2023-08-04
Enrollment: 20
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Geriatric Depression Scale-15 Items (GDS-15)
timeFrame: Change from Baseline GDS-15 total score at immediate post-intervention follow-up
measure: Rey Auditory Verbal Learning Test (RAVLT) Total Recall
timeFrame: Change from Baseline RAVLT Total Recall total score at immediate post-intervention follow-up
Secondary outcomes:
measure: Cornell Scale for Depression in Dementia (CSDD)
timeFrame: Change from Baseline CSDD total score at immediate post-intervention follow-up
measure: Cornell Scale for Depression in Dementia (CSDD)
timeFrame: Change from Baseline CSDD total score at 3 months follow-up
measure: The Center for Epidemiological Studies-Depression (CES-D)
timeFrame: Change from Baseline CES-D at immediate post-intervention follow-up
measure: The Center for Epidemiological Studies-Depression (CES-D)
timeFrame: Change from Baseline CES-D at 3 month follow-up
measure: Montreal Cognitive Assessment (MoCA) total score, memory and executive subscores
timeFrame: Change from Baseline MoCA at immediate post-intervention follow-up
measure: Montreal Cognitive Assessment (MoCA) total score, memory and executive subscores
timeFrame: Change from Baseline MoCA at 3 month follow up
measure: Digit Span (Forward and Backward)
timeFrame: Change from Baseline Digit Span (Forward and Backward) at immediate post-intervention follow-up
measure: Digit Span (Forward and Backward)
timeFrame: Change from Baseline Digit Span (Forward and Backward) at 3 month follow-up
measure: Trail making test A and B
timeFrame: Change from Baseline Trail making test A and B at immediate post-intervention follow-up
measure: Trail making test A and B
timeFrame: Change from Baseline Trail making test A and B at 3 month follow-up
measure: Category and Phonemic Fluency Test
timeFrame: Change from Baseline in Category and Phonemic Fluency Test at immediate post-intervention follow-up
measure: Category and Phonemic Fluency Test
timeFrame: Change from Baseline in Category and Phonemic Fluency Test at 3 month follow-up
measure: Functional Activity Questionnaire (FAQ)
timeFrame: Change from Baseline FAQ at immediate post-intervention follow-up
measure: Functional Activity Questionnaire (FAQ)
timeFrame: Change from Baseline FAQ at 3 month follow-up
measure: Dementia Quality of Life Questionnaire (DEMQOL)
timeFrame: Change from Baseline DEMQOL at immediate post-intervention follow-up
measure: Dementia Quality of Life Questionnaire (DEMQOL)
timeFrame: Change from Baseline DEMQOL at 3 month follow-up
measure: Altman Self-Rating Mania Scale (ASRM)
timeFrame: Change from Baseline ASRM at immediate post-intervention follow-up
measure: Altman Self-Rating Mania Scale (ASRM)
timeFrame: Change from Baseline ASRM at 3 month follow-up
measure: Rey Auditory Verbal Learning Test (RAVLT) Total Recall
timeFrame: Change from Baseline RAVLT Total Recall total score at 3 months follow-up
measure: Geriatric Depression Scale-15 Items (GDS-15)
timeFrame: Change from Baseline GDS-15 total score at 3 months follow-up
Other outcomes:
Locations:
city: Boston
country: United States
facility: Hinda and Arthur Marcus Institute for Aging Research
state: Massachusetts
Study officials:
References: