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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3 separate study visits (~1 hour each) over approximately 1 week. |
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Inclusion Criteria:
- Healthy adults aged 20-40, willing and able to undergo FUS experiments.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huiliang Wang, PhD | University of Texas at Austin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biomedical Enginering Building - UT Austin | Austin | Texas | 78705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23226567 | Background | 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. | |
| 22104527 | Background | Dickey 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. |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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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.
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| 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. |
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| 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. |
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| 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. |
| 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. | 3 separate study visits (~1 hour each) over approximately 1 week. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |