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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham | Sham Comparator | Participants undergo sham ultrasound stimulation that replicates all procedural aspects of active treatment without delivery of therapeutic acoustic energy. |
|
| Ultrasound modulation | Experimental | Participants receive ultrasound stimulation at predefined parameters to evaluate neuromodulatory effects on the target peripheral nerve. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound | Device | Non-invasive focused ultrasound stimulation is applied to a target peripheral nerve. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Device-Related Adverse Events | 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. | From treatment to the next day (up to two days) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Numerical Pain Rating Scale | 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). | During, immediately after each stimulation block, and one day after the treatment (up to two days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tom Park, PhD | Contact | tompark@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sheng Xu, PhD | Stanford University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40857198 | Background | 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. | |
| 40241493 | Background |
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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.
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Sham (No Treatment) | Device | 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. |
|
| 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. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |