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

June 8, 2026 updated by: Evan (Huiliang) Wang

Focused Ultrasound Stimulation of Peripheral Nerves in Limbs

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78705
        • Biomedical Enginering Building - UT Austin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Active Focused Ultrasound (FUS) Stimulation
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

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.

Device: Algometry Pain Tests in the Upper Limb

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.

Device: Algometry Pain Tests in the Lower Limb

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.
Sham Comparator: Sham Focused Ultrasound (FUS) Stimulation
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

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.

Device: Algometry Pain Tests in the Upper Limb

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.

Device: Algometry Pain Tests in the Lower Limb

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Completion Rate of Study Sessions
Time Frame: Through study completion (9 study visits over approximately 3 weeks).
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cold Pressor Pain Onset Time
Time Frame: 3 separate study visits (~1 hour each) over approximately 1 week.
Time (seconds) from immersion of the hand in ice water until pain is first reported; measured during baseline, sham, and active FUS sessions to characterize physiological response during feasibility testing (not powered for efficacy).
3 separate study visits (~1 hour each) over approximately 1 week.
Upper Limb Algometry Pain Threshold
Time Frame: 3 separate study visits (~1 hour each) over approximately 1 week.
Maximum tolerated pressure (kgf) at standardized points on the hand and forearm before pain is reported, measured using a pressure algometer during baseline, sham, and active FUS sessions. Recorded as an exploratory physiological response during feasibility testing.
3 separate study visits (~1 hour each) over approximately 1 week.
Lower Limb Algometry Pain Threshold
Time Frame: 3 separate study visits (~1 hour each) over approximately 1 week.
Maximum tolerated pressure (kgf) at standardized points on the foot before pain is reported, measured using a pressure algometer during baseline, sham, and active FUS sessions. Recorded as an exploratory physiological response during feasibility testing.
3 separate study visits (~1 hour each) over approximately 1 week.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Evan (Huiliang) Wang

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Huiliang Wang, PhD, University of Texas at Austin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 14, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00005942

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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