Effects of Transcutaneous Vagus Nerve Stimulation on Pain and Brain Activity in Healthy Adults
14 de septiembre de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Tipo de estudio
Intervencionista
Inscripción (Estimado)
20
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Caliel Hines
- Número de teléfono: 317-963-7010
- Correo electrónico: calhines@iu.edu
Copia de seguridad de contactos de estudio
- Nombre: Marissa Lowe
- Correo electrónico: lowemj@iu.edu
Ubicaciones de estudio
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- IU Health Neuroscience Center
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Contacto:
- Department of Neurological Surgery
- Número de teléfono: 317-963-1300
- Correo electrónico: dpurger@iu.edu
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
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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.
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Experimental: 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.
|
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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pain intensity measured by the Numerical Pain Rating Scale
Periodo de tiempo: Immediately after each of the three cold pressor tests during a single visit, approximately 90 minutes.
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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.
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Immediately after each of the three cold pressor tests during a single visit, approximately 90 minutes.
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Pain intensity measured by the Visual Analogue Scale
Periodo de tiempo: Immediately after each of the three cold pressor tests during a single visit, approximately 90 minutes.
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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.
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Immediately after each of the three cold pressor tests during a single visit, approximately 90 minutes.
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Pain threshold during cold pressor test
Periodo de tiempo: During each of the three cold pressor tests within a single visit, approximately 90 minutes.
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Time in seconds from hand immersion to the participant's first verbalized sensation of pain, recorded separately for each hand.
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During each of the three cold pressor tests within a single visit, approximately 90 minutes.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in EEG spectral power
Periodo de tiempo: Continuously throughout a single visit, approximately 90 minutes.
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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.
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Continuously throughout a single visit, approximately 90 minutes.
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Change in EEG functional connectivity
Periodo de tiempo: Continuously throughout a single visit, approximately 90 minutes.
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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.
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Continuously throughout a single visit, approximately 90 minutes.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: David A Purger, MD, PhD, Indiana University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
1 de enero de 2028
Finalización del estudio (Estimado)
1 de enero de 2028
Fechas de registro del estudio
Enviado por primera vez
14 de septiembre de 2026
Primero enviado que cumplió con los criterios de control de calidad
14 de septiembre de 2026
Publicado por primera vez (Actual)
18 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
14 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 27960
- SNEU-IIR-TVNS-ADULTS (Otro identificador: Indiana University IRB)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Sí
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .