Chronic Fatigue SyndromeNCT04399330
ME/CFS, Hypermobility and Craniocervical Obstructions
An observational study of Chronic Fatigue Syndrome, run by Bragee Clinics at 1 site in Sweden.
Trial summary
A retrospective study on clinical and radiological findings in ME/CFS Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Fatigue Syndrome
- How many people
- 225 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jun 2019to 30 Sep 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 190 women 39 men Mean duration 9 years
Who may be able to join
- Patients at a multidisciplinary specialist clinic accepting to participate
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hypermobility and Obstructions in the Craniocervical Region Among Patients With Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
A retrospective study on clinical and radiological findings in ME/CFS
- Conditions
- Chronic Fatigue Syndrome
- Medical subject headings
- Fatigue Syndrome, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of cervical obstruction and other MRI findings
Findings as disc bulging, disc hernias, chiari malformations
Measured: 1990-2020
Prevalence of hypermobility
Measured as Beighton score and other signs of Ehlers Danlos syndrome (EDS) variations
Measured: 1990-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start1 Jun 2019
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
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
- Cohort
- Time perspective
- Other
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bragee Clinics
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Björn Bragée, MD, Study director, Bragee Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04399330
- Sponsor's protocol ID
- Meret2019
- Status last verified
- May 2020
- First submitted
- 19 May 2020
- Last updated
- 26 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypermobility and Obstructions in the Craniocervical Region Among Patients With Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
- ClinicalTrials.gov ID
- NCT04399330
- Acronym / sponsor ID
- Meret2019
- Conditions
- Chronic Fatigue Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Bragee ClinicsUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 22 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 retrospective study on clinical and radiological findings in ME/CFS
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 190 women 39 men Mean duration 9 years
Key inclusion criteria (1 listed)
- Patients at a multidisciplinary specialist clinic accepting to participate
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of cervical obstruction and other MRI findings
Time frame: 1990-2020
Findings as disc bulging, disc hernias, chiari malformations
Prevalence of hypermobility
Time frame: 1990-2020
Measured as Beighton score and other signs of Ehlers Danlos syndrome (EDS) variations
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2020.
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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 Bragée, MD study director
Bragee Clinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Fatigue Syndrome, run by Bragee Clinics at 1 site in Sweden.
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: finished, as of the sponsor's last update on 26 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of cervical obstruction and other MRI findings (time frame: 1990-2020). 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 26 May 2020.