Ultrasound for Peripheral Nerve Modulation
2026年5月1日 更新者：Sheng Xu、Stanford University
Assessment of Wearable Ultrasound for Modulation
This study evaluates an ultrasound device designed to reduce pain by targeting peripheral nerves without surgery or medication. The device is placed on the skin over the area of pain and delivers controlled ultrasound stimulation.
Adults with nerve-related pain will participate in a single study visit that includes stimulation sessions and pain assessments.
The goal of this study is to determine whether non-invasive ultrasound can safely and effectively reduce pain and to assess whether this approach is practical for future clinical use.
研究概览
研究类型
介入性
注册 (估计的)
90
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Tom Park, PhD
- 邮箱：tompark@stanford.edu
学习地点
-
-
California
-
Stanford、California、美国、94305
- Stanford University
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Persons aged 18 and older.
- In good general health as evidenced by medical history
- Chronic pain located in the distribution of any of the target nerves of interest, including the occipital, suprascapular, median, femoral/leg, stellate ganglion/vagus nerves, neuroma, or amputees.
Exclusion Criteria:
- Patients with compromised skin integrity for whom device placement would result in increased risk of harm (such as those with extensive burns, active dermatologic conditions, or wounds that would prevent safe device placement)
- Pregnant patients, as the devices have not been validated in this population
- Additionally, the treating clinician may exclude any patient if they determine that study participation would be inappropriate for the patient's clinical condition.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：非随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
假比较器：Sham
Participants undergo sham ultrasound stimulation that replicates all procedural aspects of active treatment without delivery of therapeutic acoustic energy.
|
Sham stimulation replicates all procedural aspects of active ultrasound neuromodulation, including device placement and operation, without delivery of therapeutic acoustic energy.
This condition serves as a control to account for placebo and procedural effects.
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实验性的：Ultrasound modulation
Participants receive ultrasound stimulation at predefined parameters to evaluate neuromodulatory effects on the target peripheral nerve.
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Non-invasive focused ultrasound stimulation is applied to a target peripheral nerve.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of Device-Related Adverse Events
大体时间：From treatment to the next day (up to two days)
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Assessment of the number and severity of device- and procedure-related adverse events associated with focused ultrasound neuromodulation.
Events will be graded according to standard clinical criteria, including pain, skin irritation, thermal effects, or neurologic symptoms.
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From treatment to the next day (up to two days)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Numerical Pain Rating Scale
大体时间：During, immediately after each stimulation block, and one day after the treatment (up to two days)
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Participant-reported tolerability assessed using a numerical pain rating scale (e.g., discomfort or pain score during stimulation).
The scale ranges from 1 (no pain) through 10 (worst pain).
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During, immediately after each stimulation block, and one day after the treatment (up to two days)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Sheng Xu, PhD、Stanford University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- McCune EP, Blackman SG, Kamimura HAS, Bendau EV, Sachs TD, Kim S, Lee SA, Winfree CJ, Konofagou EE. Displacement-Guided Focused Ultrasound of the Median Nerve Modulates Somatosensory Evoked Potentials in Humans. IEEE Trans Biomed Eng. 2026 Mar;73(3):1255-1267. doi: 10.1109/TBME.2025.3602291.
- Ilfeld BM, Cao KN, Branson R, Bloom P. Ultrasound Neuromodulation (Low-Intensity Focused Ultrasound) to Treat Knee Osteoarthritis Pain: A Randomized, Observer- and Participant-Masked, Sham-Controlled, Human-Subjects Pilot Study. J Ultrasound Med. 2025 Sep;44(9):1713-1721. doi: 10.1002/jum.16706. Epub 2025 Apr 17.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月1日
初级完成 (估计的)
2027年6月1日
研究完成 (估计的)
2027年6月1日
研究注册日期
首次提交
2026年5月1日
首先提交符合 QC 标准的
2026年5月1日
首次发布 (实际的)
2026年5月7日
研究记录更新
最后更新发布 (实际的)
2026年5月7日
上次提交的符合 QC 标准的更新
2026年5月1日
最后验证
2026年4月1日
更多信息
与本研究相关的术语
其他研究编号
- IRB-85697
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Individual participant data (IPD) will not be shared at this stage due to the early feasibility nature of the study and the small sample size, which may increase the risk of participant re-identification.
De-identified, aggregated results will be reported in publications and presentations.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
是的
在美国制造并从美国出口的产品
是的
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.