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

Hebrew SeniorLife

Status: Enrolling

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05976659

30772

Details and patient eligibility

About

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.

Full 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).

Enrollment: 20 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

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

Experimental group

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.

Treatment:

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