Exploring How Osteopathic Manipulative Treatment May Affect Spinal Fluid Flow: An MRI Study
2026年6月1日 更新者：Edward Via Virginia College of Osteopathic Medicine
Exploring the Impact of Osteopathic Manipulative Treatment on CSF Dynamics: A Mechanistic MRI-Based Investigation
his study aims to investigate whether Osteopathic Manipulative Treatment (OMT) affects cerebrospinal fluid (CSF) flow and glymphatic clearance in the human brain. CSF plays an important role in brain health by supporting nutrient delivery, waste removal, and pressure regulation. Aging and certain neurological conditions are associated with reduced CSF circulation and impaired brain waste clearance.
Participants will undergo magnetic resonance imaging (MRI) scans before and after a 30-minute OMT session to evaluate changes in CSF flow dynamics and brain physiology. The study will also examine whether age, cognition, sleep quality, physical function, anxiety, and depression are associated with changes in CSF flow following OMT.
The study will enroll healthy adults between 18 and 80 years of age. Data collected from MRI imaging and questionnaires may help improve understanding of the physiological effects of OMT and its potential role in supporting brain health
調査の概要
状態
まだ募集していません
詳細な説明
Cerebrospinal fluid (CSF) is essential for normal central nervous system function, contributing to nutrient transport, waste clearance, and regulation of intracranial pressure. Aging is associated with reductions in CSF production, impaired glymphatic clearance, and altered CSF flow dynamics, which may contribute to cognitive decline and neurodegenerative disease processes. Although osteopathic manipulative treatment (OMT) has been proposed to influence fluid dynamics, circulation, autonomic balance, and tissue mobility, the physiological effects of OMT on CSF flow in humans remain poorly understood.
This pilot study will investigate whether OMT alters CSF dynamics and glymphatic-related imaging biomarkers in healthy adults. Thirty healthy participants will be enrolled, including individuals between 18-49 years of age and 50-80 years of age. Participants will complete MRI imaging sessions before and after a standardized 30-minute OMT session.
MRI assessments will include structural brain imaging, diffusion tensor imaging (DTI), and phase contrast MRI techniques to evaluate CSF flow, glymphatic-related diffusion metrics, and brain structural characteristics. Participants will also complete questionnaires assessing cognitive function, physical function, sleep quality, anxiety, and depression.
The study aims to:
- Determine whether CSF flow differs with aging.
- Determine whether OMT modulates CSF flow dynamics.
- Examine relationships between imaging findings and participant-reported cognitive, physical, sleep, and psychological measures.
The results of this study may improve understanding of the mechanistic effects of OMT on brain physiology and provide preliminary data for future studies evaluating OMT-related interventions targeting neurophysiological health.
研究の種類
介入
入学 (推定)
30
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Daniel Cawley, DC, MS, MSHS
- 電話番号：706-442-4105
- メール：dcawley@vcom.edu
研究連絡先のバックアップ
- 名前：Adil Bashir, PhD, MS
- 電話番号：334-844-1816
- メール：azb0117@auburn.edu
研究場所
-
-
Alabama
-
Auburn、Alabama、アメリカ、36832
- Auburn University MRI Research Center
-
コンタクト：
- Adil Bashir, PhD
- 電話番号：334-844-1816
- メール：azb0117@auburn.edu
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
Inclusion Criteria:
- Healthy adults between 18 and 80 years of age
- Able and willing to provide informed consent
- Able to safely undergo MRI procedures
- Able to participate in osteopathic manipulative treatment (OMT)
Exclusion Criteria:
- History of severe traumatic brain injury
- Fibromyalgia
- Epilepsy
- Severe neurodegenerative disorders
- Brain tumor or brain metastasis
- Stroke or cerebrovascular disease
- Hydrocephalus
- Brain malformations
- Demyelinating disorders
- Congenital abnormalities affecting cerebrospinal fluid (CSF) flow
- Spinal stenosis
- Prior brain surgery
- Chiari malformation
- Syringomyelia
- Other spinal conditions that may disrupt CSF flow
- Manual therapy within the previous 2 weeks
- Use of medications that affect CSF flow and/or production (including carbonic anhydrase inhibitors, furosemide, thiopental, desflurane, halothane, ketamine, etc.)
- Uncontrolled hypertension
- Uncontrolled diabetes
- MRI contraindications, including implanted metallic/electronic devices or -severe claustrophobia
- Pregnancy
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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 |
|---|---|
|
実験的：OMT Intervention with Pre- and Post-MRI Assessment
Participants will undergo baseline MRI imaging followed by a 30-minute osteopathic manipulative treatment (OMT) session performed by a licensed osteopathic physician.
OMT techniques may include osteopathic cranial manipulative medicine (OCMM), indirect method (IM), articulatory technique (ART), muscle energy technique (MET), facilitated positional release (FPR), tender point high-velocity low-amplitude (TP-HVLA), and myofascial release (MFR), selected based on identified somatic dysfunctions and participant tolerance.
Following treatment, participants will undergo repeat MRI imaging to assess changes in cerebrospinal fluid (CSF) flow dynamics and glymphatic-related imaging measures.
|
This intervention consists of a single 30-minute osteopathic manipulative treatment (OMT) session administered by a licensed osteopathic physician trained in neuromusculoskeletal and osteopathic manipulative medicine.
Treatment will be individualized based on findings from an osteopathic structural examination assessing somatic dysfunctions involving the head, spine, pelvis, extremities, and myofascial structures.
Standardized OMT techniques may include osteopathic cranial manipulative medicine (OCMM), indirect method (IM), articulatory technique (ART), muscle energy technique (MET), facilitated positional release (FPR), tender point high-velocity low-amplitude (TP-HVLA), and myofascial release (MFR).
The intervention is performed between pre- and post-treatment MRI sessions to evaluate acute changes in cerebrospinal fluid (CSF) dynamics and glymphatic-related imaging biomarkers.
|
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 |
|---|---|---|
|
Change in Cerebrospinal Fluid (CSF) Velocity Following OMT
時間枠：Immediately before and immediately after the single OMT session during the study visit.
|
CSF aqueductal peak and average velocity measured using phase contrast MRI before and after osteopathic manipulative treatment (OMT).
|
Immediately before and immediately after the single OMT session during the study visit.
|
|
Change in Cerebrospinal Fluid (CSF) Flow Volume Dynamics Following OMT
時間枠：Immediately before and immediately after the single OMT session during the study visit.
|
CSF forward and reverse flow volumes, net forward flow, and stroke volume measured using phase contrast MRI before and after osteopathic manipulative treatment (OMT).
|
Immediately before and immediately after the single OMT session during the study visit.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes in the Diffusion Tensor Imaging Analysis along the Perivascular Space (DTI-ALPS) index
時間枠：Immediately before and immediately after the single OMT session during the study visit.
|
An MRI diffusion tensor imaging-based physiological measure of perivascular water diffusivity, measured before and after OMT.
The DTI-ALPS assessment quantifies directional water diffusivity within white matter tracts to evaluate fluid movement along perivascular spaces.
|
Immediately before and immediately after the single OMT session during the study visit.
|
|
Correlation Between MRI-Derived CSF Flow, Velocity, and DTI-ALPS Metrics and Cognitive Function Outcomes Using the Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function Short Form and PROMIS Cognitive Abilities Short Form
時間枠：Questionnaires completed during the study visit prior to imaging procedures.
|
Association between changes in cerebrospinal fluid (CSF) flow and velocity metrics measured using magnetic resonance imaging (MRI) and changes in the Diffusion Tensor Imaging Analysis along the Perivascular Space (DTI-ALPS) index measured using diffusion tensor imaging (DTI) (units: quantitative CSF flow parameters, CSF velocity measures, and ALPS index ratio) and participant-reported cognitive function measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function Short Form and PROMIS Cognitive Abilities Short Form (unit: PROMIS T-scores; range typically 0-100, standardized mean = 50, SD = 10; higher scores indicate better cognitive function and cognitive abilities).
|
Questionnaires completed during the study visit prior to imaging procedures.
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Correlation Between MRI-Derived CSF Flow, Velocity, and DTI-ALPS Metrics and Physical Function Outcomes using the PROMIS Physical Function Short Form
時間枠：Questionnaires completed during the study visit prior to imaging procedures.
|
Correlation between changes in cerebrospinal fluid (CSF) flow and velocity metrics measured using magnetic resonance imaging (MRI) and changes in the Diffusion Tensor Imaging Analysis along the Perivascular Space (DTI-ALPS) index measured using diffusion tensor imaging (DTI) (units: quantitative CSF flow parameters, CSF velocity measures, and ALPS index ratio) and participant-reported physical function measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form (unit: PROMIS T-scores; range typically 0-100, standardized mean = 50, SD = 10; higher scores indicate better physical function).
|
Questionnaires completed during the study visit prior to imaging procedures.
|
|
Correlation Between MRI-Derived CSF Flow, Velocity, and DTI-ALPS Metrics and Sleep Quality Outcomes Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form and PROMIS Sleep-Related Impairment Short Form
時間枠：Questionnaires completed during the study visit prior to imaging procedures.
|
Correlation between changes in cerebrospinal fluid (CSF) flow and velocity metrics measured using magnetic resonance imaging (MRI) and changes in the Diffusion Tensor Imaging Analysis along the Perivascular Space (DTI-ALPS) index measured using diffusion tensor imaging (DTI) (units: quantitative CSF flow parameters, CSF velocity measures, and ALPS index ratio) and participant-reported sleep disturbance and sleep-related impairment measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form and PROMIS Sleep-Related Impairment Short Form (unit: PROMIS T-scores; range typically 0-100, standardized mean = 50, SD = 10; higher scores indicate worse sleep disturbance and greater sleep-related impairment).
|
Questionnaires completed during the study visit prior to imaging procedures.
|
|
Correlation Between MRI-Derived CSF Flow, Velocity, and DTI-ALPS Metrics and Anxiety Symptoms using the General Anxiety Disorder-7 (GAD-7) questionnaire.
時間枠：Questionnaires completed during the study visit prior to imaging procedures.
|
Correlation between changes in cerebrospinal fluid (CSF) flow and velocity metrics measured using magnetic resonance imaging (MRI) and changes in the Diffusion Tensor Imaging Analysis along the Perivascular Space (DTI-ALPS) index measured using diffusion tensor imaging (DTI) (units: quantitative CSF flow parameters, CSF velocity measures, and ALPS index ratio) and participant-reported anxiety symptoms measured using the Generalized Anxiety Disorder-7 (GAD-7) questionnaire (unit: GAD-7 total score; range 0-21, with higher scores indicating worse anxiety symptoms).
|
Questionnaires completed during the study visit prior to imaging procedures.
|
|
Correlation Between MRI-Derived CSF Flow, Velocity, and DTI-ALPS Metrics and Depressive Symptoms using the Patient Health Questionnaire-8 (PHQ-8).
時間枠：Questionnaires completed during the study visit prior to imaging procedures.
|
Association between changes in cerebrospinal fluid (CSF) flow and velocity metrics measured using magnetic resonance imaging (MRI) and changes in the Diffusion Tensor Imaging Analysis along the Perivascular Space (DTI-ALPS) index measured using diffusion tensor imaging (DTI) (units: quantitative CSF flow parameters, CSF velocity measures, and ALPS index ratio) and participant-reported depressive symptoms measured using the Patient Health Questionnaire-8 (PHQ-8) (unit: PHQ-8 total score; range 0-24, with higher scores indicating worse depressive symptoms).
|
Questionnaires completed during the study visit prior to imaging procedures.
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Daniel Cawley, DC, MS, MSHS、Edward Via College of Osteopathic Medicine
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Iliff JJ, Wang M, Liao Y, Plogg BA, Peng W, Gundersen GA, Benveniste H, Vates GE, Deane R, Goldman SA, Nagelhus EA, Nedergaard M. A paravascular pathway facilitates CSF flow through the brain parenchyma and the clearance of interstitial solutes, including amyloid beta. Sci Transl Med. 2012 Aug 15;4(147):147ra111. doi: 10.1126/scitranslmed.3003748.
- Mestre H, Mori Y, Nedergaard M. The Brain's Glymphatic System: Current Controversies. Trends Neurosci. 2020 Jul;43(7):458-466. doi: 10.1016/j.tins.2020.04.003. Epub 2020 May 15.
- Stoquart-ElSankari S, Baledent O, Gondry-Jouet C, Makki M, Godefroy O, Meyer ME. Aging effects on cerebral blood and cerebrospinal fluid flows. J Cereb Blood Flow Metab. 2007 Sep;27(9):1563-72. doi: 10.1038/sj.jcbfm.9600462. Epub 2007 Feb 21.
- Markenroth Bloch K, Toger J, Stahlberg F. Investigation of cerebrospinal fluid flow in the cerebral aqueduct using high-resolution phase contrast measurements at 7T MRI. Acta Radiol. 2018 Aug;59(8):988-996. doi: 10.1177/0284185117740762. Epub 2017 Nov 15.
- Tamburella F, Piras F, Piras F, Spano B, Tramontano M, Gili T. Cerebral Perfusion Changes After Osteopathic Manipulative Treatment: A Randomized Manual Placebo-Controlled Trial. Front Physiol. 2019 Apr 5;10:403. doi: 10.3389/fphys.2019.00403. eCollection 2019.
- Kashyap S, Brazdzionis J, Savla P, Berry JA, Farr S, Patchana T, Majeed G, Ghanchi H, Bowen I, Wacker MR, Miulli DE. Osteopathic Manipulative Treatment to Optimize the Glymphatic Environment in Severe Traumatic Brain Injury Measured With Optic Nerve Sheath Diameter, Intracranial Pressure Monitoring, and Neurological Pupil Index. Cureus. 2021 Mar 11;13(3):e13823. doi: 10.7759/cureus.13823.
- Hitscherich K, Smith K, Cuoco JA, Ruvolo KE, Mancini JD, Leheste JR, Torres G. The Glymphatic-Lymphatic Continuum: Opportunities for Osteopathic Manipulative Medicine. J Am Osteopath Assoc. 2016 Mar;116(3):170-7. doi: 10.7556/jaoa.2016.033.
- Attier-Zmudka J, Serot JM, Valluy J, Saffarini M, Macaret AS, Diouf M, Dao S, Douadi Y, Malinowski KP, Baledent O. Decreased Cerebrospinal Fluid Flow Is Associated With Cognitive Deficit in Elderly Patients. Front Aging Neurosci. 2019 Apr 30;11:87. doi: 10.3389/fnagi.2019.00087. eCollection 2019.
- Mestre H, Tithof J, Du T, Song W, Peng W, Sweeney AM, Olveda G, Thomas JH, Nedergaard M, Kelley DH. Flow of cerebrospinal fluid is driven by arterial pulsations and is reduced in hypertension. Nat Commun. 2018 Nov 19;9(1):4878. doi: 10.1038/s41467-018-07318-3.
- Benveniste H, Lee H, Volkow ND. The Glymphatic Pathway: Waste Removal from the CNS via Cerebrospinal Fluid Transport. Neuroscientist. 2017 Oct;23(5):454-465. doi: 10.1177/1073858417691030. Epub 2017 Feb 2.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月1日
一次修了 (推定)
2027年6月1日
研究の完了 (推定)
2027年8月1日
試験登録日
最初に提出
2026年5月21日
QC基準を満たした最初の提出物
2026年6月1日
最初の投稿 (実際)
2026年6月5日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月5日
QC基準を満たした最後の更新が送信されました
2026年6月1日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- STUDY00001182
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
De-identified individual participant data underlying the results reported in publications, including MRI-derived imaging measures and questionnaire data, may be shared with qualified researchers upon reasonable request following publication of the primary study results.
Data sharing will require approval by the principal investigator and execution of appropriate data use agreements to protect participant confidentiality.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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。