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Not yet recruiting NCT07629765

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

No phase Interventional Osteopathic Manipulative Treatment (OMT) Effects on Cerebrospinal Fluid (CSF) Dynamics

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Osteopathic Manipulative Treatment (OMT).
Who it may be relevant to
Registry conditions: Osteopathic Manipulative Treatment (OMT) Effects on Cerebrospinal Fluid (CSF) Dynamics. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Exploring the Impact of Osteopathic Manipulative Treatment on CSF Dynamics: A Mechanistic MRI-Based Investigation

Overview

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

Detailed description

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:

1. Determine whether CSF flow differs with aging. 2. Determine whether OMT modulates CSF flow dynamics. 3. 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.

Interventions

  • Other Osteopathic Manipulative Treatment (OMT)
    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

Primary outcome measures

  • Change in Cerebrospinal Fluid (CSF) Velocity Following OMT [Time frame: Immediately before and immediately after the single OMT session during the study visit.]
  • Change in Cerebrospinal Fluid (CSF) Flow Volume Dynamics Following OMT [Time frame: Immediately before and immediately after the single OMT session during the study visit.]
Secondary outcome measures (2)
  • Changes in the Diffusion Tensor Imaging Analysis along the Perivascular Space (DTI-ALPS) index [Time frame: 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 [Time frame: Questionnaires completed during the study visit prior to imaging procedures.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Auburn University MRI Research Center — Auburn

Publications

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT07629765 · STUDY00001182

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗