Therapeutic Effects of Electrical Vestibular Stimulation (EVS) on Balance and Gait
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 4
- 主要终点
- Postural Sway Measure of Balance Performance
研究概览
简要总结
The aim of the study to is determine the safety, feasibility, efficacy, and persistence of non-invasive EVS to improve balance and gait performance in healthy individuals across the lifespan. Specifically, our objective is to measure balance and gait performance before, during and after exposure to single sessions and across repeated sequences of EVS at multiple study partner sites.
详细描述
Background and Rationale
Standing balance and stable gait are maintained through the integration of sensory feedback from the visual, somatosensory (muscle, skin, tendon, and joint receptors), and vestibular systems. The quality of this feedback, and the ability of the central nervous system (brain and spinal cord) to integrate these signals and generate appropriate motor responses dictates balance and gait performance. Age-related balance decline, clinically known as presbystasis, is one of the most visible and debilitating signs of aging. More than 60 million people in the U.S. over the age of 40 live with age-related balance impairments that increase their risks of fall-related injuries and make it increasingly difficult to continue living actively and independently. 1-in-3 adults above the age of 65 falls each year and falls are the leading cause of death in seniors. But there are less than 20,000 clinical specialists in the U.S. with the tools to diagnose balance impairments, so for most people, little is done to address declining balance until after a fall-related injury occurs. The solution offered to most older adults is a mechanical balance aid such as a walker, whose prolonged use only further destabilizes balance.
Vestibular dysfunction has been identified as the primary cause of balance decline in more than 55% of adults over age 50, or around 34 million people in the U.S. This dysfunction impacts both the peripheral vestibular organs in the inner ear and central vestibular processing in the brain, and it has also been linked to cognitive decline. Current therapeutic options to restore lost balance function are limited to high-risk surgical vestibular implants. The current standard of care is exercise-based therapy that aims to help compensate for vestibular balance decline, but there remains a critical gap: no widely available non-invasive solution exists to restore lost vestibular function or prevent further deterioration.
A growing body of research indicates that low-level, non-invasive electrical stimulation of the vestibular balance system (EVS) can induce neuroplastic changes at both cellular and circuit levels, effectively restoring peripheral and central vestibular functions. Restored vestibular function has also been linked to restored cognitive function. The investigators have developed a novel sub-threshold wideband stochastic EVS (swsEVS) neuroplastic stimulation, which targets peripheral and central vestibular pathways. Multiple studies have demonstrated that the swsEVS frequencies and current levels are safe, comfortable, well-tolerated, and have no adverse side effects. These studies have also demonstrated that a therapeutic treatment protocol with 18 twenty-minute swsEVS sessions delivered over a 5-6-week period resulted in significant improvements in balance performance in otherwise healthy adults aged 50-98 years old. These improvements are attributed to neuroplastic restoration of both peripheral and central vestibular function. The observed improvements persisted for at least 3-6 months and were sufficient to recategorize high fall risk individuals to lower fall risk.
Objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to complete balance assessments such as standing with feet together/eyes open and feet together/eyes closed, both for at least 1 minute at a time, with no more than 1 minute rest required between tests.
- •Able to complete gait assessment tests such as walking up to 200m on a flat surface without assistance.
排除标准
- •Participants must not be using a pacemaker, cochlear implant, or any other implanted electronic device.
- •Participants must be free from any diagnosed neurological or musculoskeletal injuries and/or disorders other than those explicitly being investigated (i.e., vertigo, multiple sclerosis, Parkinson's disease, concussion).
- •Participants must have the mental capacity to provide consent and perform tasks required by the experiment.
研究组 & 干预措施
Electrical vestibular stimulation treatment
Participants in this Arm will receive active treatment with swsEVS applied
干预措施: electrical vestibular stimulation (EVS) (Device)
Sham stimulation treatment
Participants in this Arm will receive sham treatment with no swsEVS applied.
干预措施: Sham Comparator (Device)
结局指标
主要结局
Postural Sway Measure of Balance Performance
时间窗: From enrollment through the end of treatment and up to 6 months post treatment
Postural sway will be calculated from acceleration profiles of the head measured using data from a head-mounted accelerometer in eyes open and eyes closed conditions. The raw acceleration signals are in units of G. The outcome measure is expressed as a sway power value (in Watts). Sway power measured during static standing has been shown to be a precise, quickly administered assessment of balance performance with excellent sensitivity in the identification of older adult fallers. We will complete the above 2-minute postural sway assessment (60 seconds eyes open followed by 60 seconds eyes closed) immediately before and after each of the 18 EVS treatment sessions in order to track each study participant's changes in balance performance following each treatment session and the cumulative change following completion of the 18 session treatment protocol.
Sensory Integration Measure of Balance Performance
时间窗: From enrollment through the end of treatment and up to 6 months post treatment
Sensory integration will be calculated from acceleration profiles of the head measured using data from a head-mounted accelerometer in eyes open and eyes closed conditions. The raw acceleration signals are in units of G. The outcome measure is calculated using a frequency spectrum analysis of the normalized contributions of the three sensory inputs (visual, vestibular, proprioceptive) to balance control. Sensory integration measured during static standing using wearable sensors or computerized dynamic posturography has been shown to be a precise, quickly administered assessment of sensory contributions to balance control with excellent sensitivity in the identification of sensory impairments that disrupt balance in older adults. Sensory reweighting will be calculated using the head acceleration data from the above 2-minute postural sway assessment (60 seconds eyes open followed by 60 seconds eyes closed) immediately before and after each of the 18 EVS treatment sessions in order to tr
Gait Velocity Measure of Gait Performance
时间窗: From enrollment through the end of treatment and up to 6 months post treatment
Dynamic gait performance will be measured using data from a head-mounted accelerometer. The raw acceleration signals are in units of G. For dynamic gait tasks, the outcome measures will be the peak walking speed (in Meters per Second) achieved over a set of pre-defined distances from 3 meters to 100 meters. Wearable sensor-based gait velocity tests are widely used in research for older adults with and without pathology, and have norm referenced values and robust clinimetric properties. The above gait velocity measurements will be carried out prior to the first EVS treatment session and following the final (18th) EVS treatment session in order to track the cumulative change in each study participant's gait performance following completion of the 18 session treatment protocol.
Gait Cadence Measure of Gait Performance
时间窗: From enrollment through the end of treatment and up to 6 months post treatment
Dynamic gait performance will be measured using data from a head-mounted accelerometer. The raw acceleration signals are in units of G. For dynamic gait tasks, the outcome measures will be gait cadence (in Steps per Second) over a set of pre-defined distances from 3 meters to 100 meters. Wearable sensor-based gait cadence tests are widely used in research for older adults with and without pathology, and have norm referenced values and robust clinimetric properties. The above gait cadence measurements will be carried out prior to the first EVS treatment session and following the final (18th) EVS treatment session in order to track the cumulative change in each study participant's gait performance following completion of the 18 session treatment protocol.
Step Length Measure of Gait Performance
时间窗: From enrollment through the end of treatment and up to 6 months post treatment
Dynamic gait performance will be measured using data from a head-mounted accelerometer. The raw acceleration signals are in units of G. For dynamic gait tasks, the outcome measures will be step length (in Meters) over a set of pre-defined distance from 3 meters to 100 meters. Wearable sensor-based step length tests are widely used in research for older adults with and without pathology, and have norm referenced values and robust clinimetric properties. The above step length measurements will be carried out prior to the first EVS treatment session and following the final (18th) EVS treatment session in order to track the cumulative change in each study participant's gait performance following completion of the 18 session treatment protocol.
Step Trajectory Measure of Gait Performance
时间窗: From enrollment through the end of treatment and up to 6 months post treatment
Dynamic gait performance will be measured using data from a head-mounted accelerometer. The raw acceleration signals are in units of G. For dynamic gait tasks, the outcome measures will be the distribution of head trajectories during each step (in Angular Degrees) over a set of pre-defined distances from 3 meters to 100 meters. Wearable sensor-based step trajectory tests are widely used in research for older adults with and without pathology, and have norm referenced values and robust clinimetric properties. The above step trajectory measurements will be carried out prior to the first EVS treatment session and following the final (18th) EVS treatment session in order to track the cumulative change in each study participant's gait performance following completion of the 18 session treatment protocol.
次要结局
- Symbol Digit Matching Task (SDMT) Measure of Cognitive Performance(From enrollment through the end of treatment and up to 6 months post treatment)
- Montreal Cognitive Assessment (MoCA) of Cognitive Performance(From enrollment through the end of treatment and up to 6 months post treatment)