Ultrasound for Peripheral Nerve Modulation

NCT07572591 — Not applicable, Not yet recruiting, 90 participants, Stanford University

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Assessment of Wearable Ultrasound for Modulation

Registry	NCT07572591
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; non randomized, crossover, masking: double, other
Enrollment	90 (Estimated)
Sponsor	Stanford University (Other)
Conditions	Neuropathic Pain, Chronic Pain
Interventions	Ultrasound, Sham (No Treatment) (Device)
Dates	start 2026-06-01 (estimated), primary completion 2027-06-01 (estimated), completion 2027-06-01 (estimated), first posted 2026-05-07, last updated 2026-05-07
Locations	1 site in United States

-Summary

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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+Arms and interventions

Arm	Type	Interventions	Description
Sham	Sham comparator	Device: Sham (No Treatment)	Participants undergo sham ultrasound stimulation that replicates all procedural aspects of active treatment without delivery of therapeutic acoustic energy.
Ultrasound modulation	Experimental	Device: Ultrasound	Participants receive ultrasound stimulation at predefined parameters to evaluate neuromodulatory effects on the target peripheral nerve.

Ultrasound (Device): Non-invasive focused ultrasound stimulation is applied to a target peripheral nerve.
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.

+Outcome measures

Primary outcomes

Incidence of Device-Related Adverse Events [From treatment to the next day (up to two days)]: 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.

Secondary outcomes

Change in Numerical Pain Rating Scale [During, immediately after each stimulation block, and one day after the treatment (up to two days)]: 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).

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

1. Stated willingness to comply with all study procedures and availability for the duration of the study
2. Persons aged 18 and older.
3. In good general health as evidenced by medical history
4. 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.

+Locations (1)

Facility	City	Country	Status
Stanford University	Stanford, California	United States

+Publications

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. PMID 40857198
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. PMID 40241493

+Investigators

Sheng Xu, PhD, Study director, Stanford University