An interventional study of Active transcutaneous vagus nerve stimulation and Sham transcutaneous vagus nerve stimulation in Acute Pain, Pain Perception and Healthy Adult Participants, sponsored by David A. Purger. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by David A. Purger · Not applicable, Interventional, and Basic science
Among 350 studies in Acute Pain with a site in United States — 47 open to participants now, 52 under way, none of them phase 3. Acute Pain · United States.
Among the 350 studies in Acute Pain with a site in United States, this one is the 262nd largest by planned enrollment of the 319 interventional ones, is one of 12 that started in 2026, is one of 122 with no phase, reaches primary completion later than 46 of the 51 other live ones, and was the 349th registered.
1,073 studies on the registry are indexed under Acute Pain; 166 are open to participants now.
This study's planned enrollment of 20 is below the median of 86 across 902 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →47 of the 350 studies in Acute Pain with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 101 Acute Pain studies recruiting now, 39 (39%) set no upper age limit and 49 (49%) stop at 75 or younger; 21 take children under 18; 24 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · healthy volunteers too.
The full table on the hub →350 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 12 started in 2026.
Median enrollment 82 across the 319 interventional studies, 100 across the 31 observational. Of the 265 that completed or were terminated, 131 (49%) have results posted.
77 of 350 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with David A. Purger as lead sponsor.
David A. Purger has 1 study filed under Acute Pain — fewer than ten, so there is no comparison to draw.
30 of the studies in Acute Pain with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07511816Eli Lilly and CompanyA Study of LY4515100 in Participants With Pain Following Third Molar Removal | 2026-11 |
| NCT05335070Rutgers, The State University of New JerseyReducing Pain From Wisdom Molar Extractions | 2026-11 |
| NCT06795126Nationwide Children's HospitalLittle NIRVANA for Pediatric Pain and Anxiety | 2026-11-30 |
| NCT05458037Women and Infants Hospital of Rhode IslandRCT of Pain Perception With Fast and Slow Tenaculum Application | 2026-12 |
| NCT03408717KK Women's and Children's HospitalEvaluation And Risk Assessment For Persistent Postsurgical Pain After Breast Surgery | 2026-12-31 |
Among the 350 studies in Acute Pain with a site in United States, from their registry updates:
The goal of this clinical trial is to learn whether stimulating a nerve in the neck changes how much pain people feel. It also looks at whether this stimulation changes brain activity. The study is being done in healthy adults ages 18 to 70.
The nerve being studied is called the vagus nerve. It runs through the neck and connects to parts of the brain that handle pain. In this study, the nerve is stimulated from outside the body using a small device placed on the skin. There is no surgery, and nothing is implanted.
The main questions it aims to answer are: (1) Does stimulating the vagus nerve lower the pain people feel during a cold water test? (2) Does stimulating the vagus nerve change the electrical activity in the brain?
Researchers will compare pain ratings and brain activity under three conditions in the same person: no stimulation, real stimulation over the vagus nerve, and sham stimulation placed nearby on the neck. Sham stimulation feels similar but is not aimed at the nerve.
Participants will: (1) Come to one visit that lasts about 90 minutes, with no follow-up visits, (2) Wear a cap that records the brain's natural electrical signals for the whole visit, (3) Place both hands in cold water, about 39 degrees Fahrenheit, up to three times for up to 2 minutes each time, (4) Rate their pain after each cold water test, (5) Wear a stimulation device on the neck during two of the three cold water tests, (6) Not be told which of those two is the real stimulation until the visit is over.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants complete a cold pressor test with no stimulation, then a second cold pressor test during active transcutaneous vagus nerve stimulation, then a third during sham stimulation.
Device: Active transcutaneous vagus nerve stimulation · Device: Sham transcutaneous vagus nerve stimulation · Other: Cold pressor test
Participants complete a cold pressor test with no stimulation, then a second cold pressor test during sham stimulation, then a third during active transcutaneous vagus nerve stimulation.
Device: Active transcutaneous vagus nerve stimulation · Device: Sham transcutaneous vagus nerve stimulation · Other: Cold pressor test
Stimulation applied over the cervical branch of the vagus nerve, anterior to the sternocleidomastoid along the carotid sheath. Pulse width 200 microseconds, frequency 30 Hz, rectangular monophasic waveform, intensity titrated between 17.8 and 39.5 volts to a mild tingling sensation below the threshold of discomfort. Stimulation is maintained for 20 minutes before the cold pressor test and continues throughout it.
Identical device, parameters, and duration as the active condition, differing only in placement. The device is positioned slightly posterior on the neck, away from the cervical branch of the vagus nerve.
Immersion of both hands up to the wrist in water maintained at 4 degrees Celsius with ice for up to two minutes or as long as tolerated. Performed three times per participant: once with no stimulation, once during active stimulation, and once during sham stimulation.
Pain intensity measured by the Numerical Pain Rating Scale
Participant-reported pain intensity on an 11-point scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable. Higher scores indicate greater pain. Rated immediately after each cold pressor test.
Time frame: Immediately after each of the three cold pressor tests during a single visit, approximately 90 minutes.
Pain intensity measured by the Visual Analogue Scale
Participant-reported pain intensity is marked on a 100 mm line anchored at 0 mm for no pain and 100 mm for the worst imaginable pain. The distance in millimeters from the left anchor is recorded as the score. Higher scores indicate greater pain. Rated immediately after each cold pressor test.
Time frame: Immediately after each of the three cold pressor tests during a single visit, approximately 90 minutes.
Pain threshold during cold pressor test
Time in seconds from hand immersion to the participant's first verbalized sensation of pain, recorded separately for each hand.
Time frame: During each of the three cold pressor tests within a single visit, approximately 90 minutes.
Change in EEG spectral power
Change in spectral power within canonical frequency bands (delta 1 to 4 Hz, theta 4 to 8 Hz, alpha 8 to 12 Hz, beta 13 to 30 Hz, gamma above 30 Hz), measured by continuous 16-channel electroencephalography, compared across resting baseline, stimulation without noxious stimulus, and stimulation during cold pressor test.
Time frame: Continuously throughout a single visit, approximately 90 minutes.
Change in EEG functional connectivity
Change in functional connectivity between brain regions, derived from continuous 16-channel electroencephalography. Phase locking values are computed for each pair of EEG channels within canonical frequency bands, and connectivity metrics are derived from those values. Coherence is assessed in the frequency domain. Analyses are restricted to predefined, theory-driven regions and frequency bands. Compared across resting baseline, stimulation without noxious stimulus, and stimulation during the cold pressor test.
Time frame: Continuously throughout a single visit, approximately 90 minutes.
Plan to share: No — This is a small exploratory pilot study in healthy volunteers, designed to generate preliminary effect size estimates rather than definitive findings. With a target enrollment of 20 participants at a single site, the dataset is small enough that a decision about sharing individual participant data has been deferred. The current informed consent form does not specifically address sharing de-identified individual participant data with researchers outside the study team. Any future data sharing would require review of participant consent and approval by the Indiana University Institutional Review Board. The study team will revisit this decision before study completion.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Jan 2028, 16 months later.
Of 424 non-industry interventional studies with no phase under Acute Pain, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 23. This study's planned 16 months is above that.
Counting every sponsor, half of 430 studies reached it within 11 months; a quarter within 5 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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