Advancement of Vestibular Intervention Via Portable Electrical Stimulator (VIPES)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in Postural Sway during mCTSIB Across Stimulation Conditions
研究概览
简要总结
The goal is to assess the potential benefit of stochastic galvanic vestibular stimulation (sGVS) in improving patient performance with respect to balance, gait, and/or overall vestibular function for individuals with known deficits in vestibular performance as a result of a mild traumatic brain injury (mTBI).
详细描述
The VIPES system that delivers sGVS is a small wearable device that administers stimulation aiming to improve the function of a vestibular system that has been adversely affected by mild TBI, concussion. In particular VIPES is designed to provide stimulus comprising random noise in a low frequency band (0 to 5Hz maximum) below the level of perception by the subject. The VIPES system consists of the four electrodes (two behind each ear). The stimulator can deliver the stimulation in multiple directions and receive information about the amplitude delivered accounting for skin impedance. The Bertec Portable Essential's dual-balance plate balance system and the APDM Opal V2R sensor are used as reference measurement tools for assessing clinical performance.
The study to be completed is an N=32 single-arm clinical investigation, comprised of a within-subject crossover study designed to evaluate whether electrical stimulation delivered by a wearable vestibular system can improve functional performance on clinical balance and mobility assessments. All participants will complete both Timed Up and Go (TUG) and mCTSIB + COBALT performance tests under a series of stimulation conditions.
Each test session begins with a Baseline (no stimulation) trial, followed by four additional trials under different stimulation levels: 0mA (sham), 0.33mA, 0.67mA, and 1.0mA. The stimulation sequence is randomized after Baseline. Participants are blinded to stimulation level during all trials.
Participants will be recruited from the pool of patients treated at the University of Michigan - NeuroSport Clinic for mTBI. Upon passing pre-screening through chart review and via phone, interested individuals will be scheduled for a study visit that begins with obtained informed consent. Prior to beginning the testing procedures, enrolled participants will provide demographic information (age, sex/gender, race, ethnicity), have height measured, weight measured, and provide a detailed medical history, history of present illness, a list of current medications, as well as complete a post-concussion symptoms questionnaire.
The performance tests to be completed:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Although this is a single-arm, within-subject crossover study, participants are not informed of the stimulation level (sham vs. active) applied during each test. Stimulation levels (0mA sham, 0.33mA, 0.67mA, 1.0mA) are randomized and applied silently without cue or display. The participants cannot distinguish the stimulation level during testing. Therefore, participant masking is maintained.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with concussion, evaluated at the University of Michigan
- •Symptoms persistent greater than 4-6 weeks
- •Self-reported imbalance
- •Must be able to attend in-person session.
- •No racial/ethnic groups will be excluded, although all participants must be fluent speakers of English.
排除标准
- •Anyone under the age of 18 or over the age of 55
- •Presence of prior diagnosis of peripheral vestibulopathy
- •Women who are pregnant
- •Inability to complete testing (e.g., severe symptom burden, inability to stand unassisted).
研究组 & 干预措施
All Participants: Randomized Stimulation Sequence
All participants complete all performance test types (TUG and mCTSIB + COBALT), and complete each performance test under all stimulation levels (Baseline + 0mA + 0.33mA + 0.67mA + 1.0mA). Test order and stimulation sequence are randomized.
干预措施: Stochastic Galvanic Vestibular Stimulation (sGVS) (Device)
结局指标
主要结局
Change in Postural Sway during mCTSIB Across Stimulation Conditions
时间窗: Performance assessed when VIPES is worn and patient is completing the testing procedure.
Comparison of sway area (deg/s) during mCTSIB at stimulation conditions (0.33mA, 0.67mA, and 1mA) in comparison to randomized Sham (0mA).
Change in TUG Time to Completion
时间窗: Performance assessed when VIPES is worn and patient is completing the testing procedure.
Comparison of time to complete the Timed Up and Go (TUG) test (seconds) at stimulation conditions (0.33mA, 0.67mA, and 1mA) in comparison to randomized Sham (0mA).
Change in Postural Sway during COBALT
时间窗: Performance assessed when VIPES is worn and patient is completing the testing procedures
Comparison of sway area (deg/s) during COBALT at stimulation conditions (0.33mA, 0.67mA, and 1mA) in comparison to randomized Sham (0mA).
次要结局
未报告次要终点