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Structural Problems in Brainstem and Cervical Spine Cord in ME/CFS

Sponsor
Bragee Clinics (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04403854
Collaborator
(none)
100
Enrollment
60
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

A case control study on patients with ME/CFS and healthy controls on prevalence of cervical obstructions, Cerebro spinal fluid (CSF) pressure and laboratory findings.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: MRI
  • Procedure: Spinal Tap

Detailed Description

50 patients and 50 healthy controls will undergo clinical exams and blood test of inflammatory and other findings as well as magnetic resonance imaging (MRI) with spectroscopy. The patients will undergo csf -sampling and measurements of CSF pressure.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
The ME-SH (Myalgic Encephalomyelitis in Stockholm-Harvard) Study: Structural Problems in Brainstem and Cervical Spine Cord in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome(ME/CFS) - a Case-control Study
Anticipated Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Mar 31, 2025
Anticipated Study Completion Date :
Mar 31, 2026

Arms and Interventions

Arm Intervention/Treatment
ME/CFS patients

Patients diagnosed according to Canada Criteria 2003

Diagnostic Test: MRI
If possible with spectroscopy
Other Names:
  • Cervical MRI, Brain MRI

    • Procedure: Spinal Tap
    together with CSF pressure estimate
    Other Names:
  • CFS sampling

    		•
    Healthy Controls

    Age and sex matched healthy controls

    Diagnostic Test: MRI
    If possible with spectroscopy
    Other Names:
  • Cervical MRI, Brain MRI

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Prevalance of cervical obstructions [Two days]

      MRI findings

    2. Prevalence of Intracranial Hypertension [Two days]

      CSF measurements

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    Diagnose Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) according to Canada Consensus Criteria from 2003

    Exclusion Criteria:

    Bleeding abnormality Contraindication to Magnetic Resonance Imaging MRI Pregnancy

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Bragee Clinics

    Investigators

    • Study Chair: Björn Bragee, MD, Medect Clinical Trials

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bragee Clinics
    ClinicalTrials.gov Identifier:
    NCT04403854
    Other Study ID Numbers:
    • BRAGEE MEPRO
    First Posted:
    May 27, 2020
    Last Update Posted:
    Jun 4, 2020
    Last Verified:
    May 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Fatigue Syndrome, Chronic
    Syndrome
    Fatigue

    Study Results

    No Results Posted as of Jun 4, 2020