Ultrasound for Peripheral Nerve Modulation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ultrasound, Sham (No Treatment).
- Who it may be relevant to
- Registry conditions: Neuropathic Pain, Chronic Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Assessment of Wearable Ultrasound for Modulation
Overview
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.
Interventions
- Device Ultrasound
Non-invasive focused ultrasound stimulation is applied to a target peripheral nerve. - Device Sham (No Treatment)
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 outcome measures
- Incidence of Device-Related Adverse Events [Time frame: From treatment to the next day (up to two days)]
Secondary outcome measures (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)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Other
Study locations
United States · 1 center
- Stanford University — Stanford
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
Identifiers
NCT: NCT07572591 · IRB-85697