Home-based electrical stimulation to help older adults at risk of falling
Feasibility of Home-based tES for Older Adults at Risk of Falling
This study is testing a home-based electrical stimulation treatment to see if it can help older adults who have fallen improve their mobility and reduce their risk of falling again.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Hebrew SeniorLife Academic / other |
| Locations | 1 site (Roslindale, Massachusetts) |
| Trial ID | NCT04732533 on ClinicalTrials.gov |
What this trial studies
This project aims to assess the feasibility of a caregiver-administered, home-based transcranial electrical stimulation (tES) intervention designed to improve mobility in older adults who have experienced falls. The study involves a four-phase approach, starting with the development of training materials for participants and their caregivers. In the pilot phase, pairs of participants will test the home-based tES system to evaluate its practicality and effectiveness in enhancing mobility and reducing fall risk. The intervention is particularly focused on older adults with cognitive challenges that affect their balance and mobility.
Who should consider this trial
Good fit: Ideal candidates include ambulatory adults aged 60 and older who have experienced falls or have concerns about falling, along with a caregiver who can administer the treatment.
Not a fit: Patients who do not have a caregiver available to administer the treatment or those with severe cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the risk of falls among older adults, improving their mobility and overall quality of life.
How similar studies have performed: While the use of tES in clinical settings has shown promise, this home-based approach is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Inclusion criteria will be the same for PF/PA pairs in both Phase 1 and Phase 2 of the study. All participant pairs who complete either Phase 1 or 2 will be eligible to complete Phase 3. All participant teams who complete Phase 3 in its entirety will be eligible to complete Phase 4 PF group: * Aged 60+ * Self-report of one or more falls within the past year, and/or concern of falling in the future, and/or self-report of Parkinson's disease. * Able to read, write, and communicate in English * Able to identify an eligible PA to participate with them in the study PA group: * 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 tDCS * Stated availability during weekdays throughout the study period to administer tDCS to the PF 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.
Where this trial is running
Roslindale, Massachusetts
- Hebrew Rehabilitation Center — Roslindale, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Brad Manor, PhD — Hebrew SeniorLife
- Study coordinator: Nicole LaGanke
- Email: nicolelaganke@hsl.harvard.edu
- Phone: 617-971-5303
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.