Vestibular DisorderNCT06688578
Testing Effectiveness of a Stochastic Noise Stimulator to Immediately Improve Balance and Gait
A study testing Subperceptual Stimulus in people with Vestibular Disorder and Aging, run by Massachusetts Eye and Ear Infirmary at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vestibular Disorder, Aging
- What is being tested?
- Subperceptual Stimulus
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Sep 2026to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Any person with a self-reported history of:
- impaired proprioception
- significant eye problems
- neuromuscular disease
- seizure
- stroke
Show all 16Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Johns Hopkins Medicine
Baltimore, Maryland, 21218
Michael C Schubert, PhD, 4109556151, mschube1@jhmi.edu
- Recruiting
Massachusetts Eye and Ear, Harvard Medical School
Boston, Massachusetts, 02114
Stephanie G Iring-Sanchez, PhD, 2019701966, siring-sanchez@meei.harvard.edu
Jorge Serrador, jserrador@meei.harvard.edu
About this study
Official title: Improvements in Balance and Gait Using a Stochastic Noise Stimulator: Short Term Response
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.
Read the 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:
- 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)
- 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.
- 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.
- 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
- Being tested
- Subperceptual Stimulus, Sham Comparator
- Keywords
- Balance and Gait, Stochastic Noise Stimulator, Neural degeneration, neuromodulation
- Medical subject headings
- Vestibular Diseases, Nerve Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subperceptual StimulusDevice
Also called Novel Treatment of Age-Related Vestibular Loss Using Subperceptual Stimulus
For each test participants will be stimulated using a subperceptual electric signal that is optimized to improve their gait.
Sham ComparatorDevice
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 group | Role | What they receive |
|---|---|---|
| Sham | Sham comparator | 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. Receives: Device: Sham Comparator |
| Stim | Experimental | 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 Receives: Device: Subperceptual Stimulus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait velocity
Gait will be measured with a set of motion sensors (Xsens MTw Awinda motion sensors). These wearable inertial monitors measure rotational rate, acceleration, magnetic field strength, and temperature. The sensors are about the size of a watch and attach with Velcro bands. The sensors are wirelessly synchronized with each other and the software, eliminating interconnecting cables and minimizing risk of falling. Gait measures will include gait velocity, gait variability, gait synchronization.
Measured: From enrollment to the end of the intervention (2 days)
Secondary outcomes (5)
Modified Clinical Test of Sensory Interaction on Balance (mCTSIB)
Previous work has demonstrated that posturography provides significant information on vestibular function in the elderly. The mCTSIB will be performed as outlined in the Neurocom geriatric balance assessment to provide an effective initial screening tool. This test involves the subjects standing quietly on a force plate while center of mass and sway are measured with eyes open and closed. To create some instability, subjects will stand quietly on a foam block placed on the force plate with eyes open and then closed. Subjects with poor vestibular function should demonstrate significantly greater sway on tests in which their eyes are closed.
Measured: From enrollment to the end of the intervention (2 days)
Ocular Torsion
OCR is a reflexive torsional eye movement response to a head tilt that has been attributed to the otoliths. It has been demonstrated that OCR is reduced in patients who lack otolithic inputs. Eye movements during OCR tests will be recorded with a videography system that uses the polar cross-correlation technique to measure ocular counter roll using gray scale information of iris patterns obtained from circular sampling paths at fixed radii from the pupil center. To assess otolithic function, binocular counter roll will be recorded with head upright, and then during passive tilting in a chair to the right and left. During the clinical OCR testing portion, the participant will be roll tilted ~30 degrees (whole body) and the eye is measured in roll for both position and velocity.
Measured: From enrollment to the end of the intervention (2 days)
Video Head Impulse Testing (vHIT)
Subject will be fitted with lightweight goggles on which a small camera is mounted. The subject is asked to look at a target while the experimenter gives abrupt horizonal head rotations through a small angle to both the left and the right. The head movement speed is measured by the sensor in the goggles, and the image of the eye is captured by the high-speed camera and processed by very fast software to yield eye velocity. This is a standard clinical vestibular test.
Measured: From enrollment to the end of the intervention (2 days)
Instrumental Timed Up and Go Test (TUG)
Subject will first sit with back against the chair and arms on the armrests. When instructed "Go", the subject will stand up, walk to a marker that is 3 meters away from the chair with their own comfortable and usual speed, and walk back, then sit back down to the chair. Time is taken from the "Go" command until the subject sit back down. This is a standard clinical test for mobility and functional ability with lower times indicate better mobility and lower fall risk.
Measured: From enrollment to the end of the intervention (2 days)
Functional Gait Assessment (FGA)
The FGA is a standard clinical test that usually include 10 walking tasks that assess different aspects of subject's balance and gait. Each task will be scored on a 4-point scale based on the subject's gait quality and stability. A total score from all walking tests will be calculated and higher scores indicate better functional gait performance.
Measured: From enrollment to the end of the intervention (2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start25 Sep 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- For each test participants will be assessed during stimulation with imperceptible random levels of electrical stimulation as well as during sham stimulation.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Collaborators
- University of Western Sydney, National Institute on Aging (NIA), Johns Hopkins University
- Responsible party
- Principal investigator, Jorge M. Serrador, Massachusetts Eye and Ear Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688578
- Sponsor's protocol ID
- 2024P002722
- Other IDs
- 7R01AG073161
- Status last verified
- Jun 2026
- First submitted
- 6 Nov 2024
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: As part of an sIRB agreement, data may be sent to grant research collaborators (Dr. Michael Schubert) at Johns Hopkins School of Medicine to aid in analysis and pursuance of study aims. All data will be de-identified and may include questionnaire results, balance, gait, eye movement data (i.e., OCR and vHIT), and stimulus parameters. Data will be shared with collaborators via current RISO-approved secure methods including REDCap, Veeva, Secure File Transfer, and MGB Dropbox. Clinical data (without any personal identifiers) will be available upon request to the principal investigator (Dr. Jorge Serrador) upon completion of the study.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvements in Balance and Gait Using a Stochastic Noise Stimulator: Short Term Response
- ClinicalTrials.gov ID
- NCT06688578
- Acronym / sponsor ID
- 2024P002722
- Conditions
- Vestibular Disorder, Aging
- Keywords
- Balance and Gait, Stochastic Noise Stimulator, Neural degeneration, neuromodulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Collaborators
- University of Western Sydney, National Institute on Aging (NIA), Johns Hopkins University
- Study start
- 25 Sep 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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)
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- For each test participants will be assessed during stimulation with imperceptible random levels of electrical stimulation as well as during sham stimulation.
| Arm | Type | Receives |
|---|---|---|
| Sham | Sham comparator | Device: Sham ComparatorDuring each testing session there will be a sham and stimulation trial of each test. The order of the sham/stim trials will be randomized. |
| Stim | Experimental | Device: Subperceptual StimulusThree 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 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (16 listed)
- impaired proprioception
- significant eye problems
- neuromuscular disease
- seizure
- stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subperceptual StimulusAlso: Novel Treatment of Age-Related Vestibular Loss Using Subperceptual StimulusFor each test participants will be stimulated using a subperceptual electric signal that is optimized to improve their gait. | Device | Stim |
| Sham ComparatorDuring intervention trial, sham comparator will consist of same stimulation device but no actual electrical stimulation will be provided by device during intervention trial. | Device | Sham |
Primary outcome
Gait velocity
Time frame: From enrollment to the end of the intervention (2 days)
Gait will be measured with a set of motion sensors (Xsens MTw Awinda motion sensors). These wearable inertial monitors measure rotational rate, acceleration, magnetic field strength, and temperature. The sensors are about the size of a watch and attach with Velcro bands. The sensors are wirelessly synchronized with each other and the software, eliminating interconnecting cables and minimizing risk of falling. Gait measures will include gait velocity, gait variability, gait synchronization.
5 secondary outcomes
Modified Clinical Test of Sensory Interaction on Balance (mCTSIB)
Time frame: From enrollment to the end of the intervention (2 days)
Ocular Torsion
Time frame: From enrollment to the end of the intervention (2 days)
Video Head Impulse Testing (vHIT)
Time frame: From enrollment to the end of the intervention (2 days)
Instrumental Timed Up and Go Test (TUG)
Time frame: From enrollment to the end of the intervention (2 days)
Functional Gait Assessment (FGA)
Time frame: From enrollment to the end of the intervention (2 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: Yes. As part of an sIRB agreement, data may be sent to grant research collaborators (Dr. Michael Schubert) at Johns Hopkins School of Medicine to aid in analysis and pursuance of study aims. All data will be de-identified and may include questionnaire results, balance, gait, eye movement data (i.e., OCR and vHIT), and stimulus parameters. Data will be shared with collaborators via current RISO-approved secure methods including REDCap, Veeva, Secure File Transfer, and MGB Dropbox. Clinical data (without any personal identifiers) will be available upon request to the principal investigator (Dr. Jorge Serrador) upon completion of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subperceptual Stimulus in people with Vestibular Disorder and Aging, run by Massachusetts Eye and Ear Infirmary at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jorge M Serrador, PhD (6177949341, jserrador@meei.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait velocity (time frame: From enrollment to the end of the intervention (2 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.