Wearable Focused Ultrasound Stimulation for Peripheral Nerve Pain Management

NCT07160049 | Active Not Recruiting FDA Device

• 1 other identifier: STUDY00005942
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain Management; Peripheral Neuropathic Pain

Keywords

Focused Ultrasound; Peripheral Nerve Stimulation; Wearable Neurotechnology; Non-Invasive Neuromodulation; Pain Threshold; Pain Modulation; Radial Nerve; Tibial Nerve; Saphenous Nerve; Experimental Pain Testing; Ultrasound Neuromodulation

Outcome Measures

Primary Outcomes (1)

• Completion Rate of Study Sessions

  Proportion of participants who complete all nine planned sessions (baseline, sham, active FUS for cold pressor, upper limb algometry, and lower limb algometry) without withdrawal or device malfunction.

  Through study completion (9 study visits over approximately 3 weeks).

Secondary Outcomes (3)

• Cold Pressor Pain Onset Time

  3 separate study visits (~1 hour each) over approximately 1 week.

• Upper Limb Algometry Pain Threshold

  3 separate study visits (~1 hour each) over approximately 1 week.

• Lower Limb Algometry Pain Threshold

  3 separate study visits (~1 hour each) over approximately 1 week.

Study Arms (2)

Active Focused Ultrasound (FUS) Stimulation

EXPERIMENTAL

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.

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

Sham Focused Ultrasound (FUS) Stimulation

SHAM COMPARATOR

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.

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

Interventions

Cold Pressor Task - Upper Limb DEVICE

This study uses a three-session cold pressor paradigm to evaluate feasibility of a wearable focused ultrasound (FUS) device for peripheral nerve stimulation. Session 1 (Baseline): After consent, participants immerse the dominant hand in 0-1 °C water (\~10 cm depth) in an insulated bucket. Time to first pain is recorded, with 5 min rests between immersions (12 total; max single immersion 6 min). Water temperature is digitally monitored, with ice added as needed. Session 2 (Sham): The median/ulnar/radial nerve in the dominant forearm is located by ultrasound. The FUS device is applied with hydrogel but set to sham (no output). The cold pressor protocol is repeated. Session 3 (Active FUS): After nerve localization, active FUS (650 kHz, 60-100% intensity, 20-30% duty cycle) is delivered for 5 min. The cold pressor test is repeated to record pain tolerance as an exploratory physiological response during feasibility testing.

Active Focused Ultrasound (FUS) Stimulation; Sham Focused Ultrasound (FUS) Stimulation

Algometry Pain Tests in the Upper Limb DEVICE

This session records pressure pain thresholds in the dominant hand with a wearable FUS device and a pressure algometer during feasibility testing. Session 1 (Baseline): After consent and briefing, the median, ulnar, and radial nerves at three points on the dominant hand (wrist, palm, finger) are located via ultrasound and marked. A pressure algometer is applied to each site, with pressure gradually increased until pain is first reported. Thresholds are recorded, with each location tested three times with short breaks. Session 2 (Sham): The same nerve sites are identified and marked. The wearable FUS device is applied with hydrogel but set to sham (no active output). The baseline algometry protocol is repeated. Session 3 (Active FUS): Following nerve localization, active FUS (650 kHz, 60-100% intensity, 20-30% duty cycle) is delivered for 5 min. The algometry test is repeated to record pressure pain thresholds as exploratory physiological responses during feasibility testing.

Active Focused Ultrasound (FUS) Stimulation; Sham Focused Ultrasound (FUS) Stimulation

Algometry Pain Tests in the Lower Limb DEVICE

This session records pressure pain thresholds in the dominant foot with a wearable FUS device and a pressure algometer during feasibility testing. Session 1 (Baseline): After consent and briefing, the tibial, saphenous, and peroneal nerves at three standardized points on the dominant foot are located via ultrasound and marked. A pressure algometer is applied to each site, and pressure is gradually increased until pain is first reported. Thresholds are recorded, with repeated trials and short breaks between tests. Session 2 (Sham): The same nerve sites are identified and marked. The wearable FUS device is applied with hydrogel but set to sham (no active output). The baseline algometry protocol is repeated. Session 3 (Active FUS): Following nerve localization, active FUS (650 kHz, 60-100% intensity, 20-30% duty cycle) is delivered for 5 min. The algometry test is then repeated to record pressure pain thresholds as exploratory physiological responses during feasibility testing.

Active Focused Ultrasound (FUS) Stimulation; Sham Focused Ultrasound (FUS) Stimulation

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

Biomedical Enginering Building - UT Austin

Austin, Texas, 78705, United States

Location

Related Publications (2)

• Lotz G, Stahlschmidt M. [Agenesis of the gallbladder]. Chirurg. 1986 Jan;57(1):37-9. No abstract available. German.

  PMID: 3514181 BACKGROUND

• Patrini C, Reggiani C, Laforenza U, Rindi G. Effect of acute and chronic ethanol administration on the transport of thiamine from plasma to different brain regions of the rat. Alcohol Alcohol. 1988;23(6):455-63.

  PMID: 3245865 BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Huiliang Wang, PhD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study uses a within-subject crossover design in which each participant completes nine sessions on separate days (\~1 hour each). For each task (cold pressor, upper limb algometry, lower limb algometry), participants undergo three conditions: baseline assessment, sham stimulation, and active FUS stimulation. Sessions are scheduled on separate days to avoid carryover effects. Each participant serves as their own control, allowing direct comparison of responses to sham and active conditions.

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: September 8, 2025
• Study Start: July 14, 2025
• Primary Completion: September 15, 2025
• Study Completion: October 15, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)