Status:
UNKNOWN
Home-based Neuromodulation to Target Depression And Memory Symptoms in Older Adults
Lead Sponsor:
Hebrew SeniorLife
Collaborating Sponsors:
Brain & Behavior Research Foundation
Conditions:
Major Depressive Disorder
Alzheimer Disease
Eligibility:
All Genders
55+ years
Phase:
NA
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 maj...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05976659
Start Date
January 24 2023
End Date
June 30 2025
Last Update
August 4 2023
Active Locations (1)
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1
Hinda and Arthur Marcus Institute for Aging Research
Boston, Massachusetts, United States, 02131