Ultrasound for Peripheral Nerve Modulation

Stanford University

Status: Begins enrollment this month

Conditions: Neuropathic Pain; Chronic Pain

Treatments: Device: Ultrasound; Device: Sham (No Treatment)

Study type: Interventional

Funder types: Other

Identifiers

NCT07572591

IRB-85697

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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90 participants in 2 patient groups

Sham

Sham Comparator group

Description:

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

Treatment:

Device: Sham (No Treatment)

Ultrasound modulation

Experimental group

Description:

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

Treatment:

Device: Ultrasound