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

Launched by HEBREW SENIORLIFE · Jul 27, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new home-based therapy designed to help older adults who are dealing with both depression and memory problems, particularly those with major depressive disorder and dementia. The therapy uses a technique called transcranial electrical stimulation (tES), which involves sending small electrical currents to specific areas of the brain to improve mood and memory. The goal is to see if this treatment is effective and feasible for older adults in their own homes.

To participate, you need to be an older adult who can understand the study and has a caregiver who can help administer the therapy. Participants should be able to read, write, and communicate in English, and must not have certain medical conditions that would make the therapy unsafe, such as a recent seizure or specific implanted devices. Throughout the study, participants will receive tES therapy at home, and there's an emphasis on making sure everyone understands what the study involves. If you're interested, this trial is currently recruiting participants, and it's a chance to contribute to research that may help others facing similar challenges.

Gender

ALL

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