미주신경 자극이 턱관절 장애에 미치는 영향.
조기 폐경 전 여성의 턱관절 장애(TMD) 증상 및 뇌 기전에 대한 경피적 비침습적 미주신경 자극(nVNS) 효과에 대한 파일럿 연구
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.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Allison Vaughan, MPH
- 전화번호: 3108257206
- 이메일: ChurchLab@mednet.ucla.edu
연구 장소
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California
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Los Angeles, California, 미국, 90095
- 모병
- University of California, Los Angeles
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Active nVNS Treatment
nVNS Treatment 2x/week for 8 weeks |
nVNS treatment 2x/week for 8 consecutive weeks.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pain Intensity
기간: 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
기간: 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
기간: 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.
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Arpana Church, Ph.D., The Regents of the University of California, Los Angeles
- 수석 연구원: Sunil Kapila, B.D.S., M.S., Ph.D., The Regents of the University of California, Los Angeles
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .