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Recruiting NCT06688578

NCT06688578 Testing Effectiveness of a Stochastic Noise Stimulator to Immediately Improve Balance and Gait

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Clinical Trial Summary
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

Condition Vestibular Disorder
Sponsor Massachusetts Eye and Ear Infirmary
Study Type INTERVENTIONAL
Phase N/A
Enrollment 120
Sex ALL
Min Age 21 Years
Max Age N/A
Start Date 2026-02-25
Completion 2026-05-31
Interventions
Subperceptual StimulusSham Comparator

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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

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