NCT06688578 Testing Effectiveness of a Stochastic Noise Stimulator to Immediately Improve Balance and Gait
| NCT ID | NCT06688578 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts Eye and Ear Infirmary |
| Condition | Vestibular Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2026-02-25 |
| Primary Completion | 2026-05-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The goal of this intervention study is to determine if a new electronic stimulation device, similar to a TENS can improve balance and make walking easier in older individuals with reduced balance function. The main question aims to answer the following: Can using the device improve walking speed in older individuals? Participants will be asked to perform a number of tasks while wearing the device: Walk for 6 minutes * Stand in place while having balance measured (eyes open and closed) * Stand on a foam block while having balance measured (eyes open and closed) * Sit in a chair that will tilt +/- 20 degrees while wearing goggles that take videos of the participants eyes.
Eligibility 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