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

Edward Via Virginia College of Osteopathic Medicine logo

Edward Via Virginia College of Osteopathic Medicine

Status

Not yet enrolling

Conditions

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

Treatments

Other: Osteopathic Manipulative Treatment (OMT)

Study type

Interventional

Funder types

Other

Identifiers

NCT07629765
STUDY00001182

Details and patient eligibility

About

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

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

OMT Intervention with Pre- and Post-MRI Assessment
Experimental group
Description:
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.
Treatment:
Other: Osteopathic Manipulative Treatment (OMT)

Trial contacts and locations

1

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Central trial contact

Daniel Cawley, DC, MS, MSHS; Adil Bashir, PhD, MS

Data sourced from clinicaltrials.gov

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