迷走神経刺激が顎関節症に及ぼす影響。
経皮的非侵襲性迷走神経刺激(nVNS)が更年期前の顎関節症(TMD)女性の症状および脳メカニズムに及ぼす影響に関するパイロット研究
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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Allison Vaughan, MPH
- 電話番号:3108257206
- メール:ChurchLab@mednet.ucla.edu
研究場所
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California
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Los Angeles、California、アメリカ、90095
- 募集
- University of California, Los Angeles
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的:Active nVNS Treatment
nVNS Treatment 2x/week for 8 weeks |
nVNS treatment 2x/week for 8 consecutive weeks.
他の名前:
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pain Intensity
時間枠: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
時間枠: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
時間枠: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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協力者と研究者
スポンサー
捜査官
- 主任研究者:Arpana Church, Ph.D.、The Regents of the University of California, Los Angeles
- 主任研究者:Sunil Kapila, B.D.S., M.S., Ph.D.、The Regents of the University of California, Los Angeles
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。