Home-based Neuromodulation to Target Depression And Memory Symptoms in Older Adults

NCT05976659 | Unknown FDA Device

• 1 other identifier: 30772
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Geriatric Depression Scale-15 Items (GDS-15)

  This questionnaire is designed to evaluate depression in older adults.

  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.

  Change from Baseline RAVLT Total Recall total score at immediate post-intervention follow-up

Secondary Outcomes (20)

• Cornell Scale for Depression in Dementia (CSDD)

  Change from Baseline CSDD total score at immediate post-intervention follow-up

• Cornell Scale for Depression in Dementia (CSDD)

  Change from Baseline CSDD total score at 3 months follow-up

• The Center for Epidemiological Studies-Depression (CES-D)

  Change from Baseline CES-D at immediate post-intervention follow-up

• The Center for Epidemiological Studies-Depression (CES-D)

  Change from Baseline CES-D at 3 month follow-up

• Montreal Cognitive Assessment (MoCA) total score, memory and executive subscores

  Change from Baseline MoCA at immediate post-intervention follow-up

Study Arms (1)

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.

Device: Transcranial direct current stimulation (tDCS); Transcranial alternating current stimulation (tACS)

Interventions

Transcranial direct current stimulation (tDCS); Transcranial alternating current stimulation (tACS) DEVICE

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.

Also known as: Transcranial electrical stimulation (tES)

tDCS prefrontal cortex + tASC angular gyrus in MDD in the context of AD

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hebrew SeniorLife: lead
• Brain & Behavior Research Foundation: collaborator

Study Sites (1)

Hinda and Arthur Marcus Institute for Aging Research

Boston, Massachusetts, 02131, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Alzheimer Disease; Dementia; Nervous System Diseases; Memory Disorders; Depressive Disorder

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

HomeStim Study

CONTACT

617-971-5415; MoodMemStim@hsl.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: August 4, 2023
• Study Start: January 24, 2023
• Primary Completion: January 31, 2025
• Study Completion: June 30, 2025
• Last Updated: August 4, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be available at the end of the study.
• 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.

Locations

US (1)