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Effects of Transcutaneous Vagus Nerve Stimulation on Pain and Brain Activity in Healthy Adults

14 september 2026 bijgewerkt door: David A. Purger

The Effects of Transcutaneous Vagus Nerve Stimulation (tVNS) on Acute Pain Perception and Brain Activity in Healthy Adults

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

20

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Verenigde Staten
    • Indiana
      • Indianapolis, Indiana, Verenigde Staten, 46202
        • IU Health Neuroscience Center
        • Contact:
          • Department of Neurological Surgery
          • Telefoonnummer: 317-963-1300
          • E-mail: dpurger@iu.edu

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

Inclusion Criteria:

  • Adults aged 18 to 70 years
  • Healthy, defined as having no history of chronic medical, neurological, or psychiatric conditions
  • Not currently experiencing acute illness or chronic pain
  • Not currently taking medications that influence the nervous system or pain sensitivity
  • Willing and able to provide written informed consent in English

Exclusion Criteria:

  • History of vagal or vasovagal symptoms
  • Respiratory distress
  • Cardiac arrhythmia
  • Sleep apnea
  • Pregnancy
  • Substance abuse
  • Primary psychiatric disorder
  • Prior vagus nerve stimulation or any implanted medical device
  • Significant acute or chronic neurologic illness that, in the judgment of the Principal Investigator, could compromise participant safety, limit the ability to complete the study, or compromise the objectives of the study

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Active Stimulation First, Then Sham
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.
Apparaat: Active transcutaneous vagus nerve stimulation
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.
Apparaat: Sham transcutaneous vagus nerve stimulation
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.
Ander: Cold pressor test
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.
Experimenteel: Sham Stimulation First, Then Active
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.
Apparaat: Active transcutaneous vagus nerve stimulation
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.
Apparaat: Sham transcutaneous vagus nerve stimulation
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.
Ander: Cold pressor test
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pain intensity measured by the Numerical Pain Rating Scale
Tijdsspanne: Immediately after each of the three cold pressor tests during a single visit, approximately 90 minutes.
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.
Immediately after each of the three cold pressor tests during a single visit, approximately 90 minutes.
Pain intensity measured by the Visual Analogue Scale
Tijdsspanne: Immediately after each of the three cold pressor tests during a single visit, approximately 90 minutes.
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.
Immediately after each of the three cold pressor tests during a single visit, approximately 90 minutes.
Pain threshold during cold pressor test
Tijdsspanne: During each of the three cold pressor tests within a single visit, approximately 90 minutes.
Time in seconds from hand immersion to the participant's first verbalized sensation of pain, recorded separately for each hand.
During each of the three cold pressor tests within a single visit, approximately 90 minutes.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in EEG spectral power
Tijdsspanne: Continuously throughout a single visit, approximately 90 minutes.
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.
Continuously throughout a single visit, approximately 90 minutes.
Change in EEG functional connectivity
Tijdsspanne: Continuously throughout a single visit, approximately 90 minutes.
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.
Continuously throughout a single visit, approximately 90 minutes.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

David A. Purger

Medewerkers

Purdue University
Indiana University Health
Indiana University Health Methodist Hospital

Onderzoekers

  • Hoofdonderzoeker: David A Purger, MD, PhD, Indiana University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

1 januari 2028

Studie voltooiing (Geschat)

1 januari 2028

Studieregistratiedata

Eerst ingediend

14 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

14 september 2026

Eerst geplaatst (Werkelijk)

18 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

18 september 2026

Laatste update ingediend die voldeed aan QC-criteria

14 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 27960
  • SNEU-IIR-TVNS-ADULTS (Andere identificatie: Indiana University IRB)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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