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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04403854
Recruitment Status : Not yet recruiting
First Posted : May 27, 2020
Last Update Posted : June 4, 2020
Information provided by (Responsible Party):
Bragee Clinics

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
Chronic Fatigue Syndrome 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.

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Study Type : Observational
Estimated 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
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : March 31, 2026

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
ME/CFS patients
Patients diagnosed according to Canada Criteria 2003
Diagnostic Test: MRI
If possible with spectroscopy
Other Name: Cervical MRI, Brain MRI

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

Healthy Controls
Age and sex matched healthy controls
Diagnostic Test: MRI
If possible with spectroscopy
Other Name: Cervical MRI, Brain MRI

Primary Outcome Measures :
  1. Prevalance of cervical obstructions [ Time Frame: Two days ]
    MRI findings

  2. Prevalence of Intracranial Hypertension [ Time Frame: Two days ]
    CSF measurements

Biospecimen Retention:   Samples Without DNA
Blood, Cerebrospinal fluid

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Diagnoses with ME/CFS and healthy controls

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04403854

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Contact: Björn Bragee, MD 0854588875
Contact: Bo C Bertilson, MD PhD int4670732023

Sponsors and Collaborators
Bragee Clinics
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Study Chair: Björn Bragee, MD Medect Clinical Trials
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Responsible Party: Bragee Clinics Identifier: NCT04403854    
Other Study ID Numbers: BRAGEE MEPRO
First Posted: May 27, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Will be shared to other researchers with ethical approvement
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: After completed study or published results and 3 years thereafter
Access Criteria: Researchers with that have ethical approvement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fatigue Syndrome, Chronic
Pathologic Processes
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases