Gentle noise stimulator to improve balance and walking in older adults
Official title: Improvements in Balance and Gait Using a Stochastic Noise Stimulator: Short Term Response
Run by Massachusetts Eye and Ear Infirmary · NCT06688578 · Data updated 2026-11-12
This test will try a gentle, sub‑sensory electrical noise device (like a TENS) to see if it immediately improves balance and walking speed in older adults with reduced balance.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 21 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Massachusetts Eye and Ear Infirmary Academic / other |
| Locations | 2 sites (Baltimore, Maryland and 1 other locations) |
| Status | Recruiting |
| Started | September 25, 2026 |
| Main results expected | May 31, 2027 |
| Study ends | May 31, 2027 |
| Registry record updated | June 23, 2026 |
| Trial ID | NCT06688578 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with reduced balance function—particularly older adults aged 60 and over—who can stand unassisted for 30 seconds and walk for 6 minutes and do not have major medical exclusions.
✕Probably not a fit
People with implanted electronic devices, uncontrolled cardiovascular or neurologic conditions, severe eye problems, uncontrolled diabetes, recent substance abuse, or inability to stand or walk unassisted are unlikely to qualify or benefit from this device.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants will wear a small electrical stimulator that delivers subperceptual stochastic noise to the vestibular system and will be compared with a sham (no effective stimulation). During sessions participants perform a 6‑minute walk, standing balance tests with eyes open and closed on firm and foam surfaces, and a tilting chair protocol while eye movements are recorded. The primary outcome is immediate change in walking speed, with secondary outcomes including measures of postural sway and vestibular-related eye movements. The study enrolls older adults (60+) and younger adults (21–59) to characterize age-related responses and device effects.
Why it matters
Potential benefit: If successful, the device could provide a non-invasive, immediate way to improve balance and walking speed and potentially reduce fall risk in older adults.
How similar studies have gone: Previous lab work has linked age-related vestibular decline to balance problems, and smaller proof-of-concept studies of vestibular noise stimulation have suggested immediate balance improvements, but large-scale clinical benefit remains unproven.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria Older (ages 60+) and younger (aged 21-59) participants with no significant health history will be recruited from the community. Exclusion Criteria Any person with a self-reported history of: * impaired proprioception * significant eye problems * neuromuscular disease * seizure * stroke * unmedicated diabetes * cardiovascular disease (except controlled hypertension) * renal disease or electrolyte imbalance * orthopedic disorders such as severe neck or back pain * uncontrolled high blood pressure (200/110 or greater) * implanted electronic devices (pacemakers, defibrillators, implanted pumps or stimulator devices, cochlear, etc.) * psychotic medications or current psychotic symptoms * Any other psychiatric condition requiring hospitalization since 1991 * recent history of alcohol or drug abuse within the past 6 months * inability to stand unassisted for 30 seconds or walk unassisted for 6 minutes
Where it's running
-
Massachusetts Eye and Ear, Harvard Medical School
Boston, Massachusetts, United States Recruiting -
Johns Hopkins Medicine
Baltimore, Maryland, United States Not yet recruiting
Study contacts
- Study coordinator: Jorge M Serrador, PhD
- Email: jserrador@meei.harvard.edu
- Phone: 6177949341
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.