NCT04399330

Brief Summary

A retrospective study on clinical and radiological findings in ME/CFS

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 22, 2020

Completed
Last Updated

May 26, 2020

Status Verified

May 1, 2020

Enrollment Period

4 months

First QC Date

May 19, 2020

Last Update Submit

May 21, 2020

Conditions

Chronic Fatigue Syndrome

Outcome Measures

Primary Outcomes (2)

  • Prevalence of cervical obstruction and other MRI findings

    Findings as disc bulging, disc hernias, chiari malformations

    1990-2020

  • Prevalence of hypermobility

    Measured as Beighton score and other signs of Ehlers Danlos syndrome (EDS) variations

    1990-2020

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

190 women 39 men Mean duration 9 years

You may qualify if:

  • Patients at a multidisciplinary specialist clinic accepting to participate

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bragee Clinics

Stockholm, 11526, Sweden

Location

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesEncephalomyelitisNeuroinflammatory DiseasesNervous System DiseasesNeuromuscular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Björn Bragée, MD

    Bragee Clinics

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2020

First Posted

May 22, 2020

Study Start

June 1, 2019

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

May 26, 2020

Record last verified: 2020-05

Locations

SE(1)