Wearable Focused Ultrasound Stimulation for Peripheral Nerve Pain Management (PERNEUS)

The University of Texas System (UT)

Status: Active, not recruiting

Conditions: Peripheral Neuropathic Pain; Pain Management

Treatments: Device: Algometry Pain Tests in the Upper Limb; Device: Algometry Pain Tests in the Lower Limb; Device: Cold Pressor Task - Upper Limb

Study type: Interventional

Funder types: Other

Identifiers

NCT07160049

STUDY00005942

Details and patient eligibility

About

This study will evaluate the feasibility of a novel wearable focused ultrasound (FUS) device for peripheral nerve stimulation in healthy volunteers. The aim is to assess device operability, usability, tolerability, and physiological responses during standardized sensory tests. Each participant will complete nine ~1-hour study sessions across multiple days, including cold pressor and algometry tasks performed under baseline, sham, and active FUS conditions.

Full description

This feasibility study will evaluate a wearable focused ultrasound (FUS) system designed for non-invasive peripheral nerve stimulation of upper and lower extremity nerves. The primary objective is to determine device feasibility - operability, tolerability, usability, and physiological responses - during standardized pain sensitivity tasks.

Each participant will complete nine sessions on separate days (~1 hour each) in a within-subject crossover design:

1. Cold pressor test (baseline, sham, active FUS) - 3 days
2. Upper limb algometry (baseline, sham, active FUS) - 3 days
3. Lower limb algometry (baseline, sham, active FUS) - 3 days

Sessions will be scheduled at least 24 hours apart to avoid carryover effects. Approximately 12-15 participants will be enrolled. Although feasibility studies often include fewer than 10 participants, this sample size was chosen to ensure variability across limb anatomy and usability testing. No efficacy hypotheses or clinical outcomes will be tested.

Enrollment: 15 estimated patients

Sex: All

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

- Healthy adults aged 20-40, willing and able to undergo FUS experiments.

Exclusion criteria

• Major physical illnesses.
• Diagnosis of a cognitive disorder.
• Cardiovascular conditions (e.g., high blood pressure, heart disease, or dysrhythmia), history of fainting or seizures, or history of frostbite.
• Open cuts, sores, or bone fractures on the limb to be immersed in water, or a history of Raynaud's phenomenon.
• Diagnosis of hypersensitivity or hyposensitivity to bodily sensations (temperature, vibrotactile, nociception).
• Inability to provide informed consent for FUS stimulation.

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

15 participants in 2 patient groups

Active Focused Ultrasound (FUS) Stimulation

Experimental group

Description:

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.

Treatment:

Device: Cold Pressor Task - Upper Limb

Device: Algometry Pain Tests in the Lower Limb

Device: Algometry Pain Tests in the Upper Limb

Sham Focused Ultrasound (FUS) Stimulation

Sham Comparator group

Description:

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.

Treatment:

Device: Cold Pressor Task - Upper Limb

Device: Algometry Pain Tests in the Lower Limb

Device: Algometry Pain Tests in the Upper Limb