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NCT04403854 Clinical Trial

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

Chronic Fatigue Syndrome Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04403854
Other study ID # BRAGEE MEPRO
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2021
Est. completion date March 31, 2026

Study information
Verified date May 2020
Source Bragee Clinics
Contact Björn Bragee, MD
Phone 0854588875
Email bjorn@bragee.se
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date March 31, 2026
Est. primary completion date March 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• MRI
If possible with spectroscopy
Procedure:
• Spinal Tap
together with CSF pressure estimate

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bragee Clinics

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalance of cervical obstructions MRI findings Two days
Primary Prevalence of Intracranial Hypertension CSF measurements Two days
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