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

Not yet recruiting

• Conditions: Chronic Fatigue Syndrome
• Interventions: Diagnostic Test: MRI; Procedure: Spinal Tap

• Registration Number: NCT04403854
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-19
• Study First Submitted QC: 2020-05-26
• Study First Posted: 2020-05-27
• Last Update Submitted: 2020-06-03
• Last Update Posted: 2020-06-04
• Study Start: 2021-04-01
• Primary Completion: 2025-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Controls	MRI	Age and sex matched healthy controls
ME/CFS patients	MRI	Patients diagnosed according to Canada Criteria 2003
ME/CFS patients	Spinal Tap	Patients diagnosed according to Canada Criteria 2003

Primary Outcome Measures

Name	Time	Method
Prevalance of cervical obstructions	Two days	MRI findings
Prevalence of Intracranial Hypertension	Two days	CSF measurements