What this study is
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.
What's being tested
- Subperceptual Stimulus
Intervention · DEVICE
For each test participants will be stimulated using a subperceptual electric signal that is optimized to improve their gait.
- Sham Comparator
Intervention · DEVICE
During intervention trial, sham comparator will consist of same stimulation device but no actual electrical stimulation will be provided by device during intervention trial.
Study details
- Official title
- Improvements in Balance and Gait Using a Stochastic Noise Stimulator: Short Term Response
- Sponsor
- Massachusetts Eye and Ear Infirmary
- Conditions
- Vestibular Disorder · Aging
- Enrolling
- 120 people
- Starts
- 2026-02-25
- Est. completion
- 2026-05-31
- Design
- Double-blind, randomized, crossover
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 21 Years and overSex ALLHealthy volunteers AcceptedYou may qualify if
- Older (ages 60+) and younger (aged 21-59) participants with no significant health history will be recruited from the community.
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openJohns Hopkins Medicine
Baltimore, Maryland, United States
- Michael C Schubert, PhD · Contact410-955-6151mschube1@jhmi.edu
Not yet recruitingMassachusetts Eye and Ear, Harvard Medical School
Boston, Massachusetts, United States
- Stephanie G Iring-Sanchez, PhD · Contact201-970-1966siring-sanchez@meei.harvard.edu
- Jorge Serrador · Contactjserrador@meei.harvard.edu
Recruiting
Study team
Sponsor
Massachusetts Eye and Ear Infirmary
Study ID 2024P002722
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.