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NCT04732533 · ClinicalTrials.gov registry record · NA
Feasibility of Home-based tES for Older Adults at Risk of Falling
A NA study of Aging and Accidental Falls, sponsored by Hebrew SeniorLife.
- Recruiting
- Registry status
- NA
- Development phase
- 72
- Enrollment target
- 1
- Study location
NCT04732533: Recruiting NA study of Aging and Accidental Falls, sponsored by Hebrew SeniorLife.
NCT04732533 is a NA study of Aging and Accidental Falls that is actively recruiting participants, run by Hebrew SeniorLife. The registered enrollment target is 72 participants, below the 2,194-participant average among 262 other Aging trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04732533, a NA study of Aging and Accidental Falls, is actively recruiting participants, sponsored by Hebrew SeniorLife.
- RECRUITING
- Registry status
- NA
- Development phase
- 72 participants
- Enrollment target
- 1
- Study location
Study Summary
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 ti
Primary Outcome
The number of screenings needed to enroll one participant
Conditions Studied
Interventions
- OTHER tES (transcranial electrical stimulation)
Study Locations (1)
Massachusetts
- Hebrew Rehabilitation Center - Roslindale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2021-01-25 |
| Est. Completion | 2026-01-30 |
| Phase | NA |
What NCT04732533 shows while recruiting
NCT04732533 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 2,194-participant average among 262 other Aging trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Aging appearing as the primary indexed condition, and to 1 intervention - of which tES (transcranial electrical stimulation) is the first listed.
NCT04732533 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04732533 about?
NCT04732533 is a clinical study titled "Feasibility of Home-based tES for Older Adults at Risk of Falling". 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 st...
What is the current status of trial NCT04732533?
This trial is currently recruiting. It is a NA study. The enrollment target is 72 participants. The study started on 2021-01-25. Estimated completion is 2026-01-30.
What conditions does trial NCT04732533 study?
This clinical trial studies the following conditions: Aging, Accidental Falls.
What interventions are being tested in trial NCT04732533?
The interventions under investigation include: tES (transcranial electrical stimulation) (OTHER).
Who is sponsoring clinical trial NCT04732533?
This trial is sponsored by Hebrew SeniorLife, which has 32 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04732533 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04732533's enrollment target sits among peer trials
72 118th of 262 higher than 140 of 262 other Aging trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Aging trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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