Pain ManagementPERNEUSNCT07160049
Wearable Focused Ultrasound Stimulation for Peripheral Nerve Pain Management
A study testing Cold Pressor Task - Upper Limb, Algometry Pain Tests in the Upper Limb and Algometry Pain Tests in the Lower Limb in people with Pain Management and Peripheral Neuropathic Pain, run by Evan (Huiliang) Wang at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Management, Peripheral Neuropathic Pain
- What is being tested?
- Cold Pressor Task - Upper Limb, Algometry Pain Tests in the Upper Limb and Algometry Pain Tests in the Lower Limb
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2025to 15 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 20-40, willing and able to undergo FUS experiments.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Biomedical Enginering Building - UT Austin
Austin, Texas, 78705
About this study
Official title: 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.
Read the 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:
- Cold pressor test (baseline, sham, active FUS) - 3 days
- Upper limb algometry (baseline, sham, active FUS) - 3 days
- 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.
- Conditions
- Pain Management, Peripheral Neuropathic Pain
- Being tested
- Cold Pressor Task - Upper Limb, Algometry Pain Tests in the Upper Limb, Algometry Pain Tests in the Lower Limb
- 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
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold Pressor Task - Upper LimbDevice
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.
Algometry Pain Tests in the Upper LimbDevice
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.
Algometry Pain Tests in the Lower LimbDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Cold Pressor Task - Upper Limb; Device: Algometry Pain Tests in the Upper Limb; Device: Algometry Pain Tests in the Lower Limb |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion (9 study visits over approximately 3 weeks).
Secondary outcomes (3)
Cold Pressor Pain Onset Time
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).
Measured: 3 separate study visits (~1 hour each) over approximately 1 week.
Upper Limb Algometry Pain Threshold
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.
Measured: 3 separate study visits (~1 hour each) over approximately 1 week.
Lower Limb Algometry Pain Threshold
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.
Measured: 3 separate study visits (~1 hour each) over approximately 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start14 Jul 2025
- Primary completion15 Sep 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evan (Huiliang) Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Evan (Huiliang) Wang, University of Texas at Austin
- Investigators
- Huiliang Wang, PhD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160049
- Sponsor's protocol ID
- STUDY00005942
- Acronym
- PERNEUS
- Status last verified
- Jun 2026
- First submitted
- 25 Jul 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Legon W, Rowlands A, Opitz A, Sato TF, Tyler WJ. Pulsed ultrasound differentially stimulates somatosensory circuits in humans as indicated by EEG and FMRI. PLoS One. 2012;7(12):e51177. doi: 10.1371/journal.pone.0051177. Epub 2012 Dec 4.
PubMed 23226567Dickey TC, Tych R, Kliot M, Loeser JD, Pederson K, Mourad PD. Intense focused ultrasound can reliably induce sensations in human test subjects in a manner correlated with the density of their mechanoreceptors. Ultrasound Med Biol. 2012 Jan;38(1):85-90. doi: 10.1016/j.ultrasmedbio.2011.09.020. Epub 2011 Nov 21.
PubMed 22104527
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focused Ultrasound Stimulation of Peripheral Nerves in Limbs
- ClinicalTrials.gov ID
- NCT07160049
- Acronym / sponsor ID
- PERNEUS / STUDY00005942
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Evan (Huiliang) WangUniversity, hospital or other
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Cold pressor test (baseline, sham, active FUS) - 3 days
- Upper limb algometry (baseline, sham, active FUS) - 3 days
- 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 design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active Focused Ultrasound (FUS) Stimulation | Experimental | Device: Cold Pressor Task - Upper Limb, Device: Algometry Pain Tests in the Upper Limb, Device: Algometry Pain Tests in the Lower LimbParticipants 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. |
| Sham Focused Ultrasound (FUS) Stimulation | Sham comparator | Device: Cold Pressor Task - Upper Limb, Device: Algometry Pain Tests in the Upper Limb, Device: Algometry Pain Tests in the Lower LimbParticipants 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 may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy adults aged 20-40, willing and able to undergo FUS experiments.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold Pressor Task - Upper LimbThis 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 | Active Focused Ultrasound (FUS) Stimulation, Sham Focused Ultrasound (FUS) Stimulation |
| Algometry Pain Tests in the Upper LimbThis 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 | Active Focused Ultrasound (FUS) Stimulation, Sham Focused Ultrasound (FUS) Stimulation |
| Algometry Pain Tests in the Lower LimbThis 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. | Device | Active Focused Ultrasound (FUS) Stimulation, Sham Focused Ultrasound (FUS) Stimulation |
Primary outcome
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.
3 secondary outcomes
Cold Pressor Pain Onset Time
Time frame: 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.
Lower Limb Algometry Pain Threshold
Time frame: 3 separate study visits (~1 hour each) over approximately 1 week.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Background: PubMed 23226567Legon W, Rowlands A, Opitz A, Sato TF, Tyler WJ. Pulsed ultrasound differentially stimulates somatosensory circuits in humans as indicated by EEG and FMRI. PLoS One. 2012;7(12):e51177. doi: 10.1371/journal.pone.0051177. Epub 2012 Dec 4.
- Background: PubMed 22104527Dickey TC, Tych R, Kliot M, Loeser JD, Pederson K, Mourad PD. Intense focused ultrasound can reliably induce sensations in human test subjects in a manner correlated with the density of their mechanoreceptors. Ultrasound Med Biol. 2012 Jan;38(1):85-90. doi: 10.1016/j.ultrasmedbio.2011.09.020. Epub 2011 Nov 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huiliang Wang, PhD principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold Pressor Task - Upper Limb, Algometry Pain Tests in the Upper Limb and Algometry Pain Tests in the Lower Limb in people with Pain Management and Peripheral Neuropathic Pain, run by Evan (Huiliang) Wang at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion Rate of Study Sessions (time frame: Through study completion (9 study visits over approximately 3 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07160049, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.