Chronic Pain, Neuropathic Pain
Conditions
Keywords
ultrasound, modulation, peripheral nerve
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.
Interventions
DEVICEUltrasound
Non-invasive focused ultrasound stimulation is applied to a target peripheral nerve.
DEVICESham (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.
Sponsors
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Device-Related Adverse Events | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Numerical Pain Rating Scale | 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). |
Countries
United States
Contacts
CONTACTTom Park, PhD
STUDY_DIRECTORSheng Xu, PhD
Stanford University
Outcome results
None listed