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NCT Number: NCT07572591

Ultrasound for Peripheral Nerve 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.

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Key information

Conditions

Neuropathic Pain Chronic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Incidence of Device-Related Adverse Events

    Time frame: 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

  1. Change in Numerical Pain Rating Scale

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Tom Park, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Assessment of Wearable Ultrasound for Modulation

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 7, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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