Exploring How Osteopathic Manipulative Treatment May Affect Spinal Fluid Flow: An MRI Study

NCT07629765 | Not Yet Recruiting

• 1 other identifier: STUDY00001182
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteopathic Manipulative Treatment (OMT) Effects on Cerebrospinal Fluid (CSF) Dynamics

Keywords

Osteopathic Manipulative Treatment; Cerebrospinal Fluid; CSF Dynamics; Brain MRI; Glymphatic System; Aging Brain; Healthy Adults; Manual Therapy

Outcome Measures

Primary Outcomes (2)

• Change in Cerebrospinal Fluid (CSF) Velocity Following OMT

  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

  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.

Secondary Outcomes (2)

• Changes in the Diffusion Tensor Imaging Analysis along the Perivascular Space (DTI-ALPS) index

  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

  Questionnaires completed during the study visit prior to imaging procedures.

Other Outcomes (4)

• Correlation Between MRI-Derived CSF Flow, Velocity, and DTI-ALPS Metrics and Physical Function Outcomes using the PROMIS Physical Function Short Form

  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

  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.

  Questionnaires completed during the study visit prior to imaging procedures.

Study Arms (1)

OMT Intervention with Pre- and Post-MRI Assessment

EXPERIMENTAL

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.

Other: Osteopathic Manipulative Treatment (OMT)

Interventions

Osteopathic Manipulative Treatment (OMT) OTHER

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.

OMT Intervention with Pre- and Post-MRI Assessment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Edward Via Virginia College of Osteopathic Medicine: lead
• Auburn University MRI Research Center: collaborator

Study Sites (1)

Auburn University MRI Research Center

Auburn, Alabama, 36832, United States

Location

Related Publications (10)

• 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.

  PMID: 17311079 BACKGROUND

• 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.

  PMID: 29141450 BACKGROUND

• 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.

  PMID: 31024346 BACKGROUND

• 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.

  PMID: 33859888 BACKGROUND

• 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.

  PMID: 26927910 BACKGROUND

• 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.

  PMID: 31114494 BACKGROUND

• 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.

  PMID: 30451853 BACKGROUND

• 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.

  PMID: 28466758 BACKGROUND

• 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.

  PMID: 32423764 BACKGROUND

• 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.

  PMID: 22896675 BACKGROUND

MeSH Terms

Interventions

Manipulation, Osteopathic

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Daniel Cawley, DC, MS, MSHS

  Edward Via College of Osteopathic Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Cawley, DC, MS, MSHS

CONTACT

706-442-4105; dcawley@vcom.edu

Adil Bashir, PhD, MS

CONTACT

334-844-1816; azb0117@auburn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 5, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)