Wearable Ultrasound for Pain Management

(PERNEUS Trial)

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas at Austin

Disqualifiers: Cardiovascular conditions, Cognitive disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new wearable device that uses focused ultrasound (sound waves) to potentially manage pain by stimulating nerves. Researchers aim to evaluate the device's effectiveness and participants' responses during various pain tests, such as cold or pressure sensations. The trial includes two groups: one using the active device and another using a sham (inactive) device for comparison. Healthy adults without major illnesses or sensitivity issues, and who can undergo ultrasound tests, are suitable candidates. As an unphased trial, this study allows participants to contribute to innovative pain management research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study is for healthy volunteers without major illnesses, it's possible that participants are expected not to be on significant medications.

What prior data suggests that this wearable focused ultrasound device is safe for peripheral nerve stimulation?

Research has shown that wearable focused ultrasound (FUS) devices hold promise for managing pain. Studies have found that these devices can safely stimulate nerves without causing harm, indicating that the treatment is generally well-tolerated.

One study pointed out that low-intensity FUS is a safe and non-invasive method for nerve stimulation, supporting the idea that wearable FUS devices can be a safe option for pain relief.

In summary, evidence suggests that wearable FUS devices are generally safe to use, with no major side effects reported in past studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the wearable ultrasound for pain management because it offers a new way to tackle pain through focused ultrasound stimulation. Unlike traditional pain management options, like medications or invasive procedures, this treatment uses non-invasive, targeted ultrasound waves to stimulate peripheral nerves, potentially altering pain perception and thresholds. This method could provide a safer alternative with fewer side effects, focusing directly on the nerves involved in pain, and it offers the convenience of a wearable device for continuous or as-needed use.

What evidence suggests that this wearable ultrasound device is effective for pain management?

Research has shown that focused ultrasound (FUS) is a promising method for managing chronic pain. It is already approved for treating certain types of pain, such as pain from bone cancer or long-lasting nerve pain. Early findings suggest that FUS can help reduce pain by stimulating nerves without surgery. In this trial, participants will receive either active focused ultrasound stimulation or sham stimulation using a wearable device. A study using a wearable ultrasound device demonstrated that it effectively targets nerves outside the brain and spinal cord. This method has been tested for different kinds of pain, including pain from diabetes-related nerve damage. While more research is needed, these early results offer hope that wearable FUS could provide a new way to manage pain. ^{1 3 4 6 7}

Who Is on the Research Team?

Huiliang Wang, PhD

Principal Investigator

University of Texas at Austin

Are You a Good Fit for This Trial?

This trial is for healthy volunteers interested in helping test a new wearable device designed to manage nerve pain. Participants should be available for nine sessions, each lasting about an hour, over several days. Specific details on who can join are not provided.

Inclusion Criteria

I am between 20 and 40 years old and can participate in FUS experiments.

Exclusion Criteria

Major physical illnesses

Diagnosis of a cognitive disorder

Diagnosis of hypersensitivity or hyposensitivity to bodily sensations (temperature, vibrotactile, nociception)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo nine ~1-hour sessions of focused ultrasound stimulation and sham procedures for peripheral nerve stimulation, including cold pressor and algometry tasks.

3 weeks

9 visits (in-person)

Follow-up

Participants are monitored for any adverse effects and device tolerability after the completion of all sessions.

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Wearable Focused Ultrasound Stimulation

Trial Overview The study is testing a novel wearable focused ultrasound (FUS) device's effectiveness in stimulating peripheral nerves during pain-inducing tests like cold pressor and algometry tasks. Volunteers will experience baseline, sham (fake treatment), and active FUS conditions.

How Is the Trial Designed?

Group I: Active Focused Ultrasound (FUS) Stimulation Experimental Treatment 3 Interventions

Participants will receive active focused ultrasound stimulation applied to peripheral nerves (radial, median, ulnar, tibial, saphenous, or peroneal) using a wearable FUS device. Stimulation will be performed during pain sensitivity assessments, including cold pressor tests and pressure algometry, to record pain perception/thresholds as exploratory physiological responses during feasibility testing.

Group II: Sham Focused Ultrasound (FUS) Stimulation Placebo Group 3 Interventions

Participants will undergo the same procedures as the experimental arm (device placement, cold pressor test, and pressure algometry) but with the FUS device set to sham (no active ultrasound output). This arm is used to control for placebo and non-specific effects of device application during pain sensitivity assessments.

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07160049

Wearable Focused Ultrasound Stimulation for Peripheral ... This study will evaluate the feasibility of a novel wearable focused ultrasound (FUS) device for peripheral nerve stimulation in healthy ...

2. medrxiv.org medrxiv.org/content/10.1101/2025.10.29.25339092v1.full-text

Fully Wearable Armband for Long-Term Peripheral ... This approach aimed to evaluate the effectiveness of focused ultrasound (FUS) stimulation on pain with our ultrasound transducer. The ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8261174/

Focused Ultrasound (FUS) for Chronic Pain Management Focused ultrasound is a promising tool for chronic pain management, being approved for thalamotomy in chronic neuropathic pain and for bone metastases-related ...

4. fusfoundation.org fusfoundation.org/diseases-and-conditions/neuropathic-pain/

Neuropathic Pain Learn how focused ultrasound could transform the quality of life and decrease the cost of care for patients with Neuropathic Pain.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2666386425002838

A wearable spiral ultrasound patch for focused ... Here, we report a first-of-its-kind wearable spiral ultrasound patch for focused ultrasound peripheral neuromodulation to alleviate diabetic neuropathic pain.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9599299/

Safety of Clinical Ultrasound Neuromodulation - PMC Transcranial ultrasound holds much potential as a safe, non-invasive modality for navigated neuromodulation, with low-intensity focused ultrasound (FUS) and ...

7. medrxiv.org medrxiv.org/content/10.1101/2025.10.29.25339092v1.full

Fully Wearable Armband for Long-Term Peripheral ... A wearable focused ultrasound (FUS) device may offer a promising solution for safe and effective pain management at home by non-invasively ...