Feasibility of Home-based tES for Older Adults at Risk of Falling (NCT04732533)
🩺 Plain-English Summary (8th-Grade Level)
In this project, the investigators propose to demonstrate the feasibility of remotely-monitored, caregiver (or spouse)-administered, home-based tES (transcranial electrical stimulation) intervention to improve mobility in ambulatory older adults with recent falls. This is a four-phase feasibility study in older, ambulatory adult participants at risk of falling due to a loss of balance (participant faller, PF) together with a willing and able participant administrator (PA) that is available during weekdays to administer tES to the PF. Phase 1 is focused on the development and refinement of our training materials for home-based tDCS (transcranial direct current stimulation) for PF/PA pairs. The objectives of this phase: 1. Identify areas of confusion and challenges for older adults. 2. Refine our training materials to accompany the home-based tDCS system. In Phase 2, the investigators will complete a pilot trial in 12 PF/PA pairs to assess the feasibility of deploying home-based tES in larger clinical trials, and to prepare for the development and implementation of such trials. The objectives of this phase: 1. Determine the mean/range number of visits needed for in-person training. 2. Compliance and retention with the study protocol. 3. Safety/side effects of home-based tES, as compared to previously established laboratory-based tES data. The investigators hypothesize that adult PAs are able to successfully administer home-based tES to PFs. The investigators also expect that PF/PA pairs will exhibit excellent adherence to the intervention and that the prevalence and severity of reported tDCS side-effects will be similar to that observed in previous laboratory-based studies. In Phase 3, the investigators will complete a pilot trial in up to 18 PF/PA pairs; i.e., those who have previously successfully completed either Phase 1 or Phase 2. The study objectives/aims for Phase 3 are: 1. Further explore compliance and retention with the study protocol over a longer time period 2. Identify safety/side effects of home-based tES over a longer time-period as compared to previously established laboratory-based tDCS interventions. In Phase 3, the investigators hypothesize that adult PA's who have previously demonstrated the ability to successfully administer tES at home, will retain competence and compliance with administration over a longer period, up to 1 year. In Phase 4, we will complete a pilot trial in up to 18 PF/PA teams; those who have previously successfully completed Phase 3. The study objective/aims for Phase 4 will be to: 1. Identify Safety, effectiveness and adherence to home-based tES over longer period of time as compared to previously established laboratory-based tES interventions. 2. Further explore the proof of Concept for the home-based tES interventions In Phase 4 we hypothesize that adult PA's who have previously demonstrated the ability to successfully administer tES at home, will adhere with the study protocol over a longer period of time, up to 3 years.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (7 items).
Location: Hebrew Rehabilitation Center — Roslindale, Massachusetts
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Exclusion criteria will be the same for PF/PA pairs in both Phase 1 and Phase 2 of the study. PF group:
- Evidence of cognitive impairment that would likely interfere with one's ability to understand the study protocol, risks/benefits, and testing procedures. This will be defined as self-reported diagnosis of Alzheimer's disease or dementia, a score of ≤19 on the Telephone Interview for Cognitive Status (TICS) at the time of telephone screening, a score of 18 or less on the Montreal Cognitive Assessment (MoCA) during the in-person screen, or an inability to understand study procedures following review of the Informed Consent form.
- Inability to stand or ambulate unassisted for at least 25 feet.
- Contraindications to tDCS, including a reported seizure within the past two years, use of neuro-active drugs, the risk of metal objects in the brain, skull, or head, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant), or the presence of any active, uncontrolled dermatological condition, such as eczema, on the scalp. PA group:
- Mild cognitive impairment defined by a TICS score ≤34 during the phone screen, a MoCA score ≤24 during the in-person screen, or insufficient understanding of study procedures following review of the Informed Consent form.
- Poor eyesight, severe arthritis in the hands, pain, deformity or other condition that interferes with successful administration of tDCS.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Hebrew Rehabilitation Center — Roslindale, Massachusetts
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.