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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorEdward Via Virginia College of Osteopathic Medicine

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

History of severe traumatic brain injury

Fibromyalgia

Epilepsy

Severe neurodegenerative disorders

Trial design

Design model

Single group

Treatments tested in this trial

  • Osteopathic Manipulative Treatment (OMT)

    Other intervention

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: OMT Intervention with Pre- and Post-MRI AssessmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Immediately before and immediately after the single OMT session during the study visit.
2

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).

Time frame
Immediately before and immediately after the single OMT session during the study visit.

Secondary outcomes

1

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

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.

Time frame
Immediately before and immediately after the single OMT session during the study visit.
2

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

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).

Time frame
Questionnaires completed during the study visit prior to imaging procedures.

Other outcomes

1

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

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).

Time frame
Questionnaires completed during the study visit prior to imaging procedures.
2

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

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).

Time frame
Questionnaires completed during the study visit prior to imaging procedures.
3

Correlation Between MRI-Derived CSF Flow, Velocity, and DTI-ALPS Metrics and Anxiety Symptoms using the General Anxiety Disorder-7 (GAD-7) questionnaire.

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).

Time frame
Questionnaires completed during the study visit prior to imaging procedures.
4

Correlation Between MRI-Derived CSF Flow, Velocity, and DTI-ALPS Metrics and Depressive Symptoms using the Patient Health Questionnaire-8 (PHQ-8).

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).

Time frame
Questionnaires completed during the study visit prior to imaging procedures.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Edward Via Virginia College of Osteopathic Medicine

Lead sponsor

Auburn University MRI Research Center

Collaborator

This trial is not recruiting at the moment. You can still explore other options: