Chronic Fatigue SyndromeNCT04403854
Structural Problems in Brainstem and Cervical Spine Cord in ME/CFS
An observational study of Chronic Fatigue Syndrome, run by Bragee Clinics.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Fatigue Syndrome
- What is being tested?
- MRI and Spinal Tap
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to 31 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Diagnoses with ME/CFS and healthy controls
Who may be able to join
- Diagnose Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) according to Canada Consensus Criteria from 2003
Who cannot join
- Bleeding abnormality Contraindication to Magnetic Resonance Imaging MRI Pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Chronic Fatigue Syndrome
- Being tested
- MRI, Spinal Tap
- Medical subject headings
- Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
Also called Cervical MRI, Brain MRI
If possible with spectroscopy
Spinal TapProcedure or surgery
Also called CFS sampling
together with CSF pressure estimate
| Study group | Role | What they receive |
|---|---|---|
| ME/CFS patients | Patients diagnosed according to Canada Criteria 2003 Receives: Diagnostic Test: MRI; Procedure: Spinal Tap | |
| Healthy Controls | Age and sex matched healthy controls Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalance of cervical obstructions
MRI findings
Measured: Two days
Prevalence of Intracranial Hypertension
CSF measurements
Measured: Two days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start1 Apr 2021 (estimated)
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bragee Clinics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Björn Bragee, MD, Study chair, Medect Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04403854
- Sponsor's protocol ID
- BRAGEE MEPRO
- Status last verified
- May 2020
- First submitted
- 19 May 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will be shared to other researchers with ethical approvement
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04403854
- Acronym / sponsor ID
- BRAGEE MEPRO
- Conditions
- Chronic Fatigue Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bragee ClinicsUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 27 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ME/CFS patients | – | Diagnostic Test: MRI, Procedure: Spinal TapPatients diagnosed according to Canada Criteria 2003 |
| Healthy Controls | – | Diagnostic Test: MRIAge and sex matched healthy controls |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnoses with ME/CFS and healthy controls
Key inclusion criteria (1 listed)
- Diagnose Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) according to Canada Consensus Criteria from 2003
Key exclusion criteria (1 listed)
- Bleeding abnormality Contraindication to Magnetic Resonance Imaging MRI Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIAlso: Cervical MRI, Brain MRIIf possible with spectroscopy | Diagnostic test | Healthy Controls, ME/CFS patients |
| Spinal TapAlso: CFS samplingtogether with CSF pressure estimate | Procedure or surgery | ME/CFS patients |
Primary outcome
Prevalance of cervical obstructions
Time frame: Two days
MRI findings
Prevalence of Intracranial Hypertension
Time frame: Two days
CSF measurements
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Individual participant dataSharing planned: Yes. Will be shared to other researchers with ethical approvement
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Björn Bragee, MD study chair
Medect Clinical Trials
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Fatigue Syndrome, run by Bragee Clinics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Björn Bragee, MD (0854588875, bjorn@bragee.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalance of cervical obstructions (time frame: Two days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020; AzTrials last refreshed its copy on 29 Oct 2026.