迷走神经刺激对颞下颌关节紊乱症的影响。
经皮非侵入性迷走神经刺激(nVNS)对患有颞下颌关节紊乱病(TMD)的绝经前女性症状及脑机制影响的初步研究
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.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Allison Vaughan, MPH
- 电话号码:3108257206
- 邮箱:ChurchLab@mednet.ucla.edu
学习地点
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California
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Los Angeles、California、美国、90095
- 招聘中
- University of California, Los Angeles
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
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Ages 18-50
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Premenopausal menstruating women*
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Participants report or present with at least 1 of 3 cardinal signs of TMD: jaw pain, limited mouth opening, or TMJ noise.
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Specific screening reveals clinical findings that include TMJ and/or masticatory and cervical muscle pain.
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Must have a negative urine test for pregnancy
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Ability to speak the English language fluently due to the standardized assessments involved
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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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Active nVNS Treatment
nVNS Treatment 2x/week for 8 weeks |
nVNS treatment 2x/week for 8 consecutive weeks.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pain Intensity
大体时间:From the baseline in-clinic visit through 8 weeks of biweekly visits, assessed immediately before and after each nVNS session.
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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.
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Pain Unpleasantness
大体时间:From the baseline in-clinic visit through 8 weeks of biweekly visits, assessed immediately before and after each nVNS session.
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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.
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Positive and Negative Affect
大体时间:From the baseline in-clinic visit through 8 weeks of biweekly visits, assessed immediately before and after each nVNS session.
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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.
|
合作者和调查者
调查人员
- 首席研究员:Arpana Church, Ph.D.、The Regents of the University of California, Los Angeles
- 首席研究员:Sunil Kapila, B.D.S., M.S., Ph.D.、The Regents of the University of California, Los Angeles
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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