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

June 3, 2020 updated by: Bragee Clinics

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Diagnoses with ME/CFS and healthy controls

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy Controls
Age and sex matched healthy controls
Diagnostic test: MRI
If possible with spectroscopy
Other Names:
  • Cervical MRI, Brain MRI
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalance of cervical obstructions
Time Frame: Two days
MRI findings
Two days
Prevalence of Intracranial Hypertension
Time Frame: Two days
CSF measurements
Two days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bragee Clinics

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2021

Primary Completion (Anticipated)

March 31, 2025

Study Completion (Anticipated)

March 31, 2026

Study Registration Dates

First Submitted

May 19, 2020

First Submitted That Met QC Criteria

May 26, 2020

First Posted (Actual)

May 27, 2020

Study Record Updates

Last Update Posted (Actual)

June 4, 2020

Last Update Submitted That Met QC Criteria

June 3, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRAGEE MEPRO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Will be shared to other researchers with ethical approvement

IPD Sharing Time Frame

After completed study or published results and 3 years thereafter

IPD Sharing Access Criteria

Researchers with that have ethical approvement.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Fatigue Syndrome

Clinical Trials on MRI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe