Exploring How Osteopathic Manipulative Treatment May Affect Spinal Fluid Flow: An MRI Study
1 czerwca 2026 zaktualizowane przez: 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
Przegląd badań
Status
Jeszcze nie rekrutacja
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Szacowany)
30
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Daniel Cawley, DC, MS, MSHS
- Numer telefonu: 706-442-4105
- E-mail: dcawley@vcom.edu
Kopia zapasowa kontaktu do badania
- Nazwa: Adil Bashir, PhD, MS
- Numer telefonu: 334-844-1816
- E-mail: azb0117@auburn.edu
Lokalizacje studiów
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Alabama
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Auburn, Alabama, Stany Zjednoczone, 36832
- Auburn University MRI Research Center
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Kontakt:
- Adil Bashir, PhD
- Numer telefonu: 334-844-1816
- E-mail: azb0117@auburn.edu
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Tak
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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.
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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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in Cerebrospinal Fluid (CSF) Velocity Following OMT
Ramy czasowe: Immediately before and immediately after the single OMT session during the study visit.
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CSF aqueductal peak and average velocity measured using phase contrast MRI before and after osteopathic manipulative treatment (OMT).
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Immediately before and immediately after the single OMT session during the study visit.
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Change in Cerebrospinal Fluid (CSF) Flow Volume Dynamics Following OMT
Ramy czasowe: Immediately before and immediately after the single OMT session during the study visit.
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CSF forward and reverse flow volumes, net forward flow, and stroke volume measured using phase contrast MRI before and after osteopathic manipulative treatment (OMT).
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Immediately before and immediately after the single OMT session during the study visit.
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Changes in the Diffusion Tensor Imaging Analysis along the Perivascular Space (DTI-ALPS) index
Ramy czasowe: Immediately before and immediately after the single OMT session during the study visit.
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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.
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Immediately before and immediately after the single OMT session during the study visit.
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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
Ramy czasowe: Questionnaires completed during the study visit prior to imaging procedures.
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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).
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Questionnaires completed during the study visit prior to imaging procedures.
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Correlation Between MRI-Derived CSF Flow, Velocity, and DTI-ALPS Metrics and Physical Function Outcomes using the PROMIS Physical Function Short Form
Ramy czasowe: Questionnaires completed during the study visit prior to imaging procedures.
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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).
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Questionnaires completed during the study visit prior to imaging procedures.
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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
Ramy czasowe: Questionnaires completed during the study visit prior to imaging procedures.
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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).
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Questionnaires completed during the study visit prior to imaging procedures.
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Correlation Between MRI-Derived CSF Flow, Velocity, and DTI-ALPS Metrics and Anxiety Symptoms using the General Anxiety Disorder-7 (GAD-7) questionnaire.
Ramy czasowe: Questionnaires completed during the study visit prior to imaging procedures.
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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).
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Questionnaires completed during the study visit prior to imaging procedures.
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Correlation Between MRI-Derived CSF Flow, Velocity, and DTI-ALPS Metrics and Depressive Symptoms using the Patient Health Questionnaire-8 (PHQ-8).
Ramy czasowe: 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).
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Questionnaires completed during the study visit prior to imaging procedures.
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Współpracownicy
Śledczy
- Główny śledczy: Daniel Cawley, DC, MS, MSHS, Edward Via College of Osteopathic Medicine
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
1 czerwca 2026
Zakończenie podstawowe (Szacowany)
1 czerwca 2027
Ukończenie studiów (Szacowany)
1 sierpnia 2027
Daty rejestracji na studia
Pierwszy przesłany
21 maja 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
1 czerwca 2026
Pierwszy wysłany (Rzeczywisty)
5 czerwca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
5 czerwca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
1 czerwca 2026
Ostatnia weryfikacja
1 czerwca 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- STUDY00001182
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu IPD
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.
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ICF
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .