Neuropathic PainNCT07572591
Ultrasound for Peripheral Nerve Modulation
A study testing Ultrasound in people with Neuropathic Pain and Chronic Pain, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain, Chronic Pain
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tom Park, PhD contact
About this study
Official title: Assessment of Wearable Ultrasound for 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.
- Conditions
- Neuropathic Pain, Chronic Pain
- Being tested
- Ultrasound, Sham (No Treatment)
- Keywords
- ultrasound, modulation, peripheral nerve
- Medical subject headings
- Neuralgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Sham | Sham comparator | Participants undergo sham ultrasound stimulation that replicates all procedural aspects of active treatment without delivery of therapeutic acoustic energy. Receives: Device: Sham (No Treatment) |
| Ultrasound modulation | Experimental | Participants receive ultrasound stimulation at predefined parameters to evaluate neuromodulatory effects on the target peripheral nerve. Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From treatment to the next day (up to two days)
Secondary outcomes (1)
Change in Numerical Pain Rating Scale
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).
Measured: During, immediately after each stimulation block, and one day after the treatment (up to two days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng Xu, Stanford University
- Investigators
- Sheng Xu, PhD, Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07572591
- Sponsor's protocol ID
- IRB-85697
- Status last verified
- Apr 2026
- First submitted
- 1 May 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data (IPD) will not be shared at this stage due to the early feasibility nature of the study and the small sample size, which may increase the risk of participant re-identification. De-identified, aggregated results will be reported in publications and presentations.
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.
PubMed 40857198Ilfeld 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.
PubMed 40241493
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Wearable Ultrasound for Modulation
- ClinicalTrials.gov ID
- NCT07572591
- Acronym / sponsor ID
- IRB-85697
- Conditions
- Neuropathic Pain, Chronic Pain
- Keywords
- ultrasound, modulation, peripheral nerve
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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: UltrasoundParticipants receive ultrasound stimulation at predefined parameters to evaluate neuromodulatory effects on the target peripheral nerve. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundNon-invasive focused ultrasound stimulation is applied to a target peripheral nerve. | Device | Ultrasound modulation |
| 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. | Device | Sham |
Primary outcome
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.
1 secondary outcome
Change in Numerical Pain Rating Scale
Time frame: During, immediately after each stimulation block, and one day after the treatment (up to two days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Background: PubMed 40857198McCune 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.
- Background: PubMed 40241493Ilfeld 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.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared at this stage due to the early feasibility nature of the study and the small sample size, which may increase the risk of participant re-identification. De-identified, aggregated results will be reported in publications and presentations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tom Park, PhD contact
Sheng Xu, PhD study director
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Neuropathic Pain and Chronic Pain, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tom Park, PhD (tompark@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Device-Related Adverse Events (time frame: From treatment to the next day (up to two days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07572591, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.