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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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04403854
Enrollment
100
Registered
2020-05-27
Start date
2021-04-01
Completion date
2026-03-31
Last updated
2020-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Fatigue Syndrome

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.

Interventions

DIAGNOSTIC_TESTMRI

If possible with spectroscopy

PROCEDURESpinal Tap

together with CSF pressure estimate

Sponsors

Bragee Clinics
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalance of cervical obstructionsTwo daysMRI findings
Prevalence of Intracranial HypertensionTwo daysCSF measurements

Contacts

Primary ContactBjörn Bragee, MD
bjorn@bragee.se0854588875
Backup ContactBo C Bertilson, MD PhD
bo.bertilson@ki.seint4670732023

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026