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

NCT ID: NCT06688578

Last Updated: 2026-01-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-25
• Study Completion Date: 2026-05-31

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.

Detailed Description

Neural degeneration with age and disease is a recognized and critical problem in health. Despite the significant problems associated with neural degenerative diseases and effects of aging, there remains a lack of effective treatments. An important neural system used daily is the vestibular system. The vestibular system provides continual information on our location in space and is integral to balance, locomotion, daily activities and quality of life. Our lab and others have demonstrated that with increasing age there is a loss of vestibular function that is associated with increased incidence of falls. In fact, falls are the leading cause of injury and death in older Americans (CDC). Older Americans experience 36 million falls per year resulting in 3 million emergency room visits, 700,000 hospitalizations and 32,000 deaths resulting in an estimated $50 billion in annual healthcare costs. Since falls in elderly individuals are associated with greatly increased mortality, reducing fall risk is an essential area to target for healthy aging. Since vestibular function is inherently involved in balance and gait, dealing with age related vestibular loss is an essential component of reducing fall risk. Similarly, patients with vestibular loss have reduced quality of life and increased risk of falls.

Our lab was the first to demonstrate that age related reductions in ocular torsion, a vestibular ocular reflex indicative of otolith function, are associated with increased postural sway in a large group of individuals (N=151) from 21-92 years. Our lab is also the first to demonstrate that subperceptual levels of random electrical stimulation, termed stochastic resonance, are able to improve ocular torsion, indicating improved otolith function, to compensate for age-related vestibular loss.6 Our lab as well as others have also demonstrated that the use of this stimulation can improve static balance and gait in a range of populations. Therefore, a neuromodulation device that could improve balance and gait and reduce fall risk would greatly improve quality of life in aging and reduce mortality. Currently, there are limited treatment options available that can compensate for vestibular loss. A novel neuromodulation treatment is clearly needed. However, current data in this lab and others have only examined the response in the lab over relatively short periods. A recent study found that 3 hours of stimulation improved static balance and this improvement lasted post stimulation for up to 4 hours. These data suggest that this stimulus could be used as a novel rehabilitation device. However there still remains several gaps in knowledge:

1. Do the improvements seen in one system translate to other systems? (i.e., if the investigators see improvement in vestibular ocular reflex, will that translate into improvements in static balance and gait)

2. Do these improvements in static balance translate into gait improvements?

The overall purpose of this study is to investigate whether low level (sub-perceptual) electrical stimulation produces improvements in vestibular function (balance system) that translate into improved balance and gait.

A. Objectives The goal of this study is to determine the cross-modality effectiveness of improving vestibular function on static balance and gait in a population of older individuals with verified reduced vestibular function.

B. Hypotheses / Research Question(s) The overall hypothesis is that stimulation of the vestibular system with extremely low level (subperceptual) electrical signals via surface electrodes will produce immediate improvements in vestibular function that will also translate into improve static balance and gait in older individuals.

Conditions

Vestibular Disorder; Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: SHAM_COMPARATOR

Sham Comparator

Intervention Type: 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.

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

Group Type: EXPERIMENTAL

Subperceptual Stimulus

Intervention Type: DEVICE

For each test participants will be stimulated using a subperceptual electric signal that is optimized to improve their gait.

Interventions

Subperceptual Stimulus

For each test participants will be stimulated using a subperceptual electric signal that is optimized to improve their gait.

Intervention Type: DEVICE

Sham Comparator

During intervention trial, sham comparator will consist of same stimulation device but no actual electrical stimulation will be provided by device during intervention trial.

Intervention Type: DEVICE

Other Intervention Names

Novel Treatment of Age-Related Vestibular Loss Using Subperceptual Stimulus

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Western Sydney

OTHER

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

Massachusetts Eye and Ear Infirmary

OTHER

Sponsor Role: lead

Responsible Party

Jorge M. Serrador

Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Johns Hopkins Medicine

Baltimore, Maryland, United States

Site Status: NOT_YET_RECRUITING

Massachusetts Eye and Ear, Harvard Medical School

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jorge M Serrador, PhD

Role: CONTACT

jserrador@meei.harvard.edu

6177949341

Stephanie G Iring-Sanchez, PhD

Role: CONTACT

siring-sanchez@meei.harvard.edu

2019701966

Facility Contacts

Michael C Schubert, PhD

Role: primary

mschube1@jhmi.edu

410-955-6151

Stephanie G Iring-Sanchez, PhD

Role: primary

siring-sanchez@meei.harvard.edu

201-970-1966

Jorge Serrador

Role: backup

jserrador@meei.harvard.edu

Other Identifiers

7R01AG073161

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2024P002722

Identifier Type: -

Identifier Source: org_study_id