- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07288411
Efeitos da Estimulação do Nervo Vago nas Desordens Temporomandibulares.
Estudo Piloto dos Efeitos da Estimulação Vagal Não Invasiva Transcutânea (nVNS) nos Sintomas e Mecanismos Cerebrais em Mulheres Pré-menopáusicas com Distúrbios Temporomandibulares (DTM)
The study aims to examine the effects of transcutaneous non-invasive vagus nerve stimulation (nVNS) on symptoms and brain mechanisms in premenopausal women with temporomandibular disorders (TMD). Non-invasive vagus nerve stimulation (nVNS) is the most well researched and possibly the most effective non-invasive neuromodulation treatment for chronic pain conditions that targets the brain-gut-microbiome (BGM) axis.
Participants will be asked to come in for 2 in-clinic visits, at baseline and post treatment. Participants will also be asked to come in 2x/week for 8 consecutive weeks to receive the nVNS treatment. The in-clinic visits will include physical measures, blood draw, saliva sample, and brain MRI. Participants will be asked to collect a stool sample at home and answer online questionnaires regarding, mood, pain, and health behaviors at home, prior to the in-clinic appointments.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Allison Vaughan, MPH
- Número de telefone: 3108257206
- E-mail: ChurchLab@mednet.ucla.edu
Locais de estudo
-
-
California
-
Los Angeles, California, Estados Unidos, 90095
- Recrutamento
- University of California, Los Angeles
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
-
Ages 18-50
-
Premenopausal menstruating women*
-
Participants report or present with at least 1 of 3 cardinal signs of TMD: jaw pain, limited mouth opening, or TMJ noise.
-
Specific screening reveals clinical findings that include TMJ and/or masticatory and cervical muscle pain.
-
Must have a negative urine test for pregnancy
-
Ability to speak the English language fluently due to the standardized assessments involved
-
Right-handed (participants are limited to right-handed individuals to reduce variability in brain lateralization and ensure more consistent, interpretable data).
- Only premenopausal women are included to control for hormonal variability that may influence the results. Participants will be scheduled during their follicular phase based on self-reported last menstrual period to further reduce hormonal confounds.
Exclusion Criteria:
- Medical condition, laboratory finding, or physical exam finding that precludes participation, such as systemic arthritides, juvenile idiopathic arthritis, idiopathic condylar resorption, connective tissue disorders, mandibular osteonecrosis, mandibular and condylar fractures, salivary gland disorders (incl. history of stones or swelling), neoplasms, neurologic/neuropathic, endocrine, or immune/autoimmune diseases and congenital or developmental disorders.
- Pathologic processes found on imaging including neoplasm (Exception: disc displacements and osseous pathology including osteoarthritis/osteoarthrosis).
- Radiation treatment to head and neck
- Prior jaw or open TMJ (including contralateral joint) surgery including plication, chondroplasty, joint replacement, disectomy, and discoplasty.
- Intra-articular therapies of TMJ being sampled that include arthrocentesis, visco-supplementation, and steroid, platelet-rich plasma/platelet-rich fibrin administration within the last 6mo
- Recent febrile illness within the past 8 weeks that precludes or delays participation by more than 90 days
- Trauma to jaw in the last 2mo
- Presence of non-TMD orofacial pain disorders excluding comorbidity of interest (fibromyalgia).
- Pregnancy or lactation
- Undergoing or previously undergone bone anabolic or other hormonal therapies for medical needs
- Unable to participate due to language barrier or mental/intellectual incompetence
- Use of antidepressant drugs unless the participants have been on a stable dose for 60 days.
- Drug and/or alcohol abuse in the past year
- Ongoing dental treatments requiring invasive procedures (e.g. implant placement, tooth extractions, etc.)
- Recent dental treatments within past two weeks that required sustained mouth opening for more than 20 minutes.
- Wearing removable or implant supported dentures or fixed orthodontic appliances
- Unable or unwilling to give informed consent
- Participation in another clinical study that interferes with participation in this study
- Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
- Presence of non-TMD orofacial pain disorders such as that from periodontal disease and carious lesions.
- Presence of major psychiatric diagnosis such as schizophrenia, bipolar disorder, post-traumatic stress disorder, obsessive compulsive disorder, or current history of drug or alcohol abuse.
- Individuals with current regular use of narcotics and/or opioids. Use of centrally acting medications that will interfere with neuroimaging testing, such as systemic steroids, opiate analgesics.
- Smokes/Vapes tobacco more than 1/3 pack per day
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Active nVNS Treatment
nVNS Treatment 2x/week for 8 weeks |
nVNS treatment 2x/week for 8 consecutive weeks.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pain Intensity
Prazo: From the baseline in-clinic visit through 8 weeks of biweekly visits, assessed immediately before and after each nVNS session.
|
To be measured using a numeric rating scale 0-10. |
From the baseline in-clinic visit through 8 weeks of biweekly visits, assessed immediately before and after each nVNS session.
|
|
Pain Unpleasantness
Prazo: From the baseline in-clinic visit through 8 weeks of biweekly visits, assessed immediately before and after each nVNS session.
|
To be measured using a visual analog scale. |
From the baseline in-clinic visit through 8 weeks of biweekly visits, assessed immediately before and after each nVNS session.
|
|
Positive and Negative Affect
Prazo: From the baseline in-clinic visit through 8 weeks of biweekly visits, assessed immediately before and after each nVNS session.
|
To be measured using the positive and negative affect scale (PANAS). |
From the baseline in-clinic visit through 8 weeks of biweekly visits, assessed immediately before and after each nVNS session.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Arpana Church, Ph.D., The Regents of the University of California, Los Angeles
- Investigador principal: Sunil Kapila, B.D.S., M.S., Ph.D., The Regents of the University of California, Los Angeles
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IRB 25-0801
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
produto fabricado e exportado dos EUA
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 .