Exploring How Osteopathic Manipulative Treatment May Affect Spinal Fluid Flow: An MRI Study
1. juni 2026 opdateret af: 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
Studieoversigt
Status
Ikke rekrutterer endnu
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
30
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Daniel Cawley, DC, MS, MSHS
- Telefonnummer: 706-442-4105
- E-mail: dcawley@vcom.edu
Undersøgelse Kontakt Backup
- Navn: Adil Bashir, PhD, MS
- Telefonnummer: 334-844-1816
- E-mail: azb0117@auburn.edu
Studiesteder
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Alabama
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Auburn, Alabama, Forenede Stater, 36832
- Auburn University MRI Research Center
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Kontakt:
- Adil Bashir, PhD
- Telefonnummer: 334-844-1816
- E-mail: azb0117@auburn.edu
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Cerebrospinal Fluid (CSF) Velocity Following OMT
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Changes in the Diffusion Tensor Imaging Analysis along the Perivascular Space (DTI-ALPS) index
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Correlation Between MRI-Derived CSF Flow, Velocity, and DTI-ALPS Metrics and Physical Function Outcomes using the PROMIS Physical Function Short Form
Tidsramme: 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).
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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
Tidsramme: 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).
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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.
Tidsramme: 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).
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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).
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Daniel Cawley, DC, MS, MSHS, Edward Via College of Osteopathic Medicine
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. juni 2026
Primær færdiggørelse (Anslået)
1. juni 2027
Studieafslutning (Anslået)
1. august 2027
Datoer for studieregistrering
Først indsendt
21. maj 2026
Først indsendt, der opfyldte QC-kriterier
1. juni 2026
Først opslået (Faktiske)
5. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- STUDY00001182
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
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