Focused Ultrasound Stimulation of Peripheral Nerves in Limbs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Completion Rate of Study Sessions
研究概览
简要总结
This study will evaluate the feasibility of a novel wearable focused ultrasound (FUS) device for peripheral nerve stimulation in healthy volunteers. The aim is to assess device operability, usability, tolerability, and physiological responses during standardized sensory tests. Each participant will complete nine ~1-hour study sessions across multiple days, including cold pressor and algometry tasks performed under baseline, sham, and active FUS conditions.
详细描述
This feasibility study will evaluate a wearable focused ultrasound (FUS) system designed for non-invasive peripheral nerve stimulation of upper and lower extremity nerves. The primary objective is to determine device feasibility - operability, tolerability, usability, and physiological responses - during standardized pain sensitivity tasks.
Each participant will complete nine sessions on separate days (~1 hour each) in a within-subject crossover design:
- Cold pressor test (baseline, sham, active FUS) - 3 days
- Upper limb algometry (baseline, sham, active FUS) - 3 days
- Lower limb algometry (baseline, sham, active FUS) - 3 days
Sessions will be scheduled at least 24 hours apart to avoid carryover effects. Approximately 12-15 participants will be enrolled. Although feasibility studies often include fewer than 10 participants, this sample size was chosen to ensure variability across limb anatomy and usability testing. No efficacy hypotheses or clinical outcomes will be tested.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Healthy adults aged 20-40, willing and able to undergo FUS experiments.
排除标准
- •Major physical illnesses.
- •Diagnosis of a cognitive disorder.
- •Cardiovascular conditions (e.g., high blood pressure, heart disease, or dysrhythmia), history of fainting or seizures, or history of frostbite.
- •Open cuts, sores, or bone fractures on the limb to be immersed in water, or a history of Raynaud's phenomenon.
- •Diagnosis of hypersensitivity or hyposensitivity to bodily sensations (temperature, vibrotactile, nociception).
- •Inability to provide informed consent for FUS stimulation.
研究组 & 干预措施
Active Focused Ultrasound (FUS) Stimulation
Participants will receive active focused ultrasound stimulation applied to peripheral nerves (radial, median, ulnar, tibial, saphenous, or peroneal) using a wearable FUS device. Stimulation will be performed during pain sensitivity assessments, including cold pressor tests and pressure algometry, to record pain perception/thresholds as exploratory physiological responses during feasibility testing.
干预措施: Algometry Pain Tests in the Upper Limb (Device)
Active Focused Ultrasound (FUS) Stimulation
Participants will receive active focused ultrasound stimulation applied to peripheral nerves (radial, median, ulnar, tibial, saphenous, or peroneal) using a wearable FUS device. Stimulation will be performed during pain sensitivity assessments, including cold pressor tests and pressure algometry, to record pain perception/thresholds as exploratory physiological responses during feasibility testing.
干预措施: Algometry Pain Tests in the Lower Limb (Device)
Active Focused Ultrasound (FUS) Stimulation
Participants will receive active focused ultrasound stimulation applied to peripheral nerves (radial, median, ulnar, tibial, saphenous, or peroneal) using a wearable FUS device. Stimulation will be performed during pain sensitivity assessments, including cold pressor tests and pressure algometry, to record pain perception/thresholds as exploratory physiological responses during feasibility testing.
干预措施: Cold Pressor Task - Upper Limb (Device)
Sham Focused Ultrasound (FUS) Stimulation
Participants will undergo the same procedures as the experimental arm (device placement, cold pressor test, and pressure algometry) but with the FUS device set to sham (no active ultrasound output). This arm is used to control for placebo and non-specific effects of device application during pain sensitivity assessments.
干预措施: Cold Pressor Task - Upper Limb (Device)
Sham Focused Ultrasound (FUS) Stimulation
Participants will undergo the same procedures as the experimental arm (device placement, cold pressor test, and pressure algometry) but with the FUS device set to sham (no active ultrasound output). This arm is used to control for placebo and non-specific effects of device application during pain sensitivity assessments.
干预措施: Algometry Pain Tests in the Upper Limb (Device)
Sham Focused Ultrasound (FUS) Stimulation
Participants will undergo the same procedures as the experimental arm (device placement, cold pressor test, and pressure algometry) but with the FUS device set to sham (no active ultrasound output). This arm is used to control for placebo and non-specific effects of device application during pain sensitivity assessments.
干预措施: Algometry Pain Tests in the Lower Limb (Device)
结局指标
主要结局
Completion Rate of Study Sessions
时间窗: Through study completion (9 study visits over approximately 3 weeks).
Proportion of participants who complete all nine planned sessions (baseline, sham, active FUS for cold pressor, upper limb algometry, and lower limb algometry) without withdrawal or device malfunction.
次要结局
- Cold Pressor Pain Onset Time(3 separate study visits (~1 hour each) over approximately 1 week.)
- Upper Limb Algometry Pain Threshold(3 separate study visits (~1 hour each) over approximately 1 week.)
- Lower Limb Algometry Pain Threshold(3 separate study visits (~1 hour each) over approximately 1 week.)
研究者
Evan (Huiliang) Wang
Assistant Professor
University of Texas at Austin