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

NCT ID: NCT04403854

Last Updated: 2020-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-01

Study Completion Date

2026-03-31

Brief Summary

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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

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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.

Conditions

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Chronic Fatigue Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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ME/CFS patients

Patients diagnosed according to Canada Criteria 2003

MRI

Intervention Type DIAGNOSTIC_TEST

If possible with spectroscopy

Spinal Tap

Intervention Type PROCEDURE

together with CSF pressure estimate

Healthy Controls

Age and sex matched healthy controls

MRI

Intervention Type DIAGNOSTIC_TEST

If possible with spectroscopy

Interventions

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MRI

If possible with spectroscopy

Intervention Type DIAGNOSTIC_TEST

Spinal Tap

together with CSF pressure estimate

Intervention Type PROCEDURE

Other Intervention Names

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Cervical MRI, Brain MRI CFS sampling

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bragee Clinics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Björn Bragee, MD

Role: STUDY_CHAIR

Medect Clinical Trials

Central Contacts

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Björn Bragee, MD

Role: CONTACT

0854588875

Bo C Bertilson, MD PhD

Role: CONTACT

int4670732023

Other Identifiers

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BRAGEE MEPRO

Identifier Type: -

Identifier Source: org_study_id

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