Home-based brain stimulation for depression and memory issues in older adults
Targeting Depression And Memory Symptoms With Multi-Focal Circuit-Based Neuromodulation
This study is testing if a home-based brain stimulation treatment can help older adults with depression and memory problems feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | Hebrew SeniorLife Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05976659 on ClinicalTrials.gov |
What this trial studies
This project investigates the feasibility and effects of a home-based neuromodulation therapy targeting mood and memory symptoms in older adults suffering from major depressive disorder (MDD) in the context of dementia. It is a single-arm pilot study that evaluates the safety, feasibility, and preliminary efficacy of transcranial direct current stimulation (tDCS) and transcranial alternating current stimulation (tACS) aimed at improving depressive and episodic memory symptoms. Participants will undergo a series of assessments before and after a 4-week intervention consisting of daily 20-minute stimulation sessions.
Who should consider this trial
Good fit: Ideal candidates are older adults with major depressive disorder who are also experiencing memory issues related to dementia.
Not a fit: Patients with contraindications to transcranial electrical stimulation or those unable to comply with study requirements may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve mood and memory symptoms in older adults with depression and dementia.
How similar studies have performed: Other studies have shown promise with similar neuromodulation approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Hinda and Arthur Marcus Institute for Aging Research — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: HomeStim Study
- Email: MoodMemStim@hsl.harvard.edu
- Phone: 617-971-5415
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.