Structural Problems in Brainstem and Cervical Spine Cord in ME/CFS
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
1 other identifier
observational
100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2021
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2020
CompletedFirst Posted
Study publicly available on registry
May 27, 2020
CompletedStudy Start
First participant enrolled
April 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2026
CompletedJune 4, 2020
May 1, 2020
4 years
May 19, 2020
June 3, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Prevalance of cervical obstructions
MRI findings
Two days
Prevalence of Intracranial Hypertension
CSF measurements
Two days
Study Arms (2)
ME/CFS patients
Patients diagnosed according to Canada Criteria 2003
Healthy Controls
Age and sex matched healthy controls
Interventions
If possible with spectroscopy
Eligibility Criteria
Diagnoses with ME/CFS and healthy controls
You may qualify if:
- Diagnose Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) according to Canada Consensus Criteria from 2003
You may not qualify if:
- Bleeding abnormality Contraindication to Magnetic Resonance Imaging MRI Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bragee Clinicslead
Biospecimen
Blood, Cerebrospinal fluid
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Björn Bragee, MD
Medect Clinical Trials
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2020
First Posted
May 27, 2020
Study Start
April 1, 2021
Primary Completion
March 31, 2025
Study Completion
March 31, 2026
Last Updated
June 4, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- After completed study or published results and 3 years thereafter
- Access Criteria
- Researchers with that have ethical approvement.
Will be shared to other researchers with ethical approvement