Effects of Transcutaneous Vagus Nerve Stimulation on Pain and Brain Activity in Healthy Adults
14 de setembro de 2026 atualizado 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.
Visão geral do estudo
Status
Ainda não está recrutando
Tipo de estudo
Intervencional
Inscrição (Estimado)
20
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Caliel Hines
- Número de telefone: 317-963-7010
- E-mail: calhines@iu.edu
Estude backup de contato
- Nome: Marissa Lowe
- E-mail: lowemj@iu.edu
Locais de estudo
-
-
Indiana
-
Indianapolis, Indiana, Estados Unidos, 46202
- IU Health Neuroscience Center
-
Contato:
- Department of Neurological Surgery
- Número de telefone: 317-963-1300
- E-mail: dpurger@iu.edu
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
|
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.
|
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pain intensity measured by the Numerical Pain Rating Scale
Prazo: 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
Prazo: 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
Prazo: 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.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in EEG spectral power
Prazo: 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
Prazo: 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.
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: David A Purger, MD, PhD, Indiana University
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de setembro de 2026
Conclusão Primária (Estimado)
1 de janeiro de 2028
Conclusão do estudo (Estimado)
1 de janeiro de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
14 de setembro de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
14 de setembro de 2026
Primeira postagem (Real)
18 de setembro de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
18 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
14 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 27960
- SNEU-IIR-TVNS-ADULTS (Outro identificador: Indiana University IRB)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano 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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Sim
produto fabricado e exportado dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .