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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Massachusetts Eye and Ear Infirmary
Study ID
NCT06688578
Status
Recruiting
Apply to this trial

Conditions

  • Aging
  • Vestibular Disorder

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Subperceptual Stimulus — DEVICE
    For each test participants will be stimulated using a subperceptual electric signal that is optimized to improve their gait.
  • Sham Comparator — 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

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.

Key Dates

Start date
Feb 25, 2026
Status verified
Jan 2026
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Sham Comparator: Sham
    During each testing session there will be a sham and stimulation trial of each test. The order of the sham/stim trials will be randomized.
  • Experimental: Stim
    Three different methods will be used to determine the level of stimulation that produces the greatest improvement in gait. The basic concept is that to determine the optimal level of stimulus the investigators apply various levels of random subperceptual electrical stimulation while measuring either vestibular ocular reflex, static sway or gait. Then the investigators will compare the performance of the selected variable at each level of stimulation to determine which amount of stimulation produced the greatest improvement in the selected variable. Once that is determined

Primary Outcome Measure

Gait velocity [ Time Frame: From enrollment to the end of the intervention (2 days) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Johns Hopkins MedicineBaltimoreMaryland21218
Michael C Schubert, PhD
[email protected]
410-955-6151
Massachusetts Eye and Ear, Harvard Medical SchoolBostonMassachusetts02114
Stephanie G Iring-Sanchez, PhD
[email protected]
201-970-1966
Jorge Serrador
[email protected]

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By research site
Johns Hopkins Medicine· Baltimore, MDMassachusetts Eye and Ear, Harvard Medical School· Boston, MA

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