Ultrasound for Peripheral Nerve Modulation

NCT07572591 | Not Yet Recruiting FDA Device

• 1 other identifier: IRB-85697
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuropathic Pain; Chronic Pain

Keywords

ultrasound; modulation; peripheral nerve

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Change in Numerical Pain Rating Scale

  During, immediately after each stimulation block, and one day after the treatment (up to two days)

Study Arms (2)

Sham

SHAM COMPARATOR

Participants undergo sham ultrasound stimulation that replicates all procedural aspects of active treatment without delivery of therapeutic acoustic energy.

Device: Sham (No Treatment)

Ultrasound modulation

EXPERIMENTAL

Participants receive ultrasound stimulation at predefined parameters to evaluate neuromodulatory effects on the target peripheral nerve.

Device: Ultrasound

Interventions

Ultrasound DEVICE

Non-invasive focused ultrasound stimulation is applied to a target peripheral nerve.

Ultrasound modulation

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.

Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Neuralgia; Chronic Pain

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Sheng Xu, PhD

  Stanford University

  STUDY DIRECTOR

Central Study Contacts

Tom Park, PhD

CONTACT

tompark@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in the Department of Anesthesiology, Perioperative, and Pain Medicine

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 7, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)