Clinical trial NCT06688578: Testing Effectiveness of a Stochastic Noise Stimulator to Immediately Improve Balance and Gait
Official title: Improvements in Balance and Gait Using a Stochastic Noise Stimulator: Short Term Response
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Vestibular Disorder
Aging
Keywords: Balance and Gait
Stochastic Noise Stimulator
Neural degeneration
neuromodulation
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
Collaborators: name: University of Western Sydney
name: National Institute on Aging (NIA)
name: Johns Hopkins University
First posted: 2024-11-14
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: For each test participants will be assessed during stimulation with imperceptible random levels of electrical stimulation as well as during sham stimulation.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Gait velocity
timeFrame: From enrollment to the end of the intervention (2 days)
Secondary outcomes:
measure: Modified Clinical Test of Sensory Interaction on Balance (mCTSIB)
timeFrame: From enrollment to the end of the intervention (2 days)
measure: Ocular Torsion
timeFrame: From enrollment to the end of the intervention (2 days)
measure: Video Head Impulse Testing (vHIT)
timeFrame: From enrollment to the end of the intervention (2 days)
measure: Instrumental Timed Up and Go Test (TUG)
timeFrame: From enrollment to the end of the intervention (2 days)
measure: Functional Gait Assessment (FGA)
timeFrame: From enrollment to the end of the intervention (2 days)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Medicine
state: Maryland
city: Boston
country: United States
facility: Massachusetts Eye and Ear, Harvard Medical School
state: Massachusetts
Study officials:
References: