Structural Problems in Brainstem and Cervical Spine Cord... | NCT04403854

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

NCT04403854

Sponsor

Bragee Clinics

Status

Unknown status

Last Update Posted

Jun 4, 2020Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Chronic Fatigue Syndrome

Interventions

MRI
Spinal Tap

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2021Estimated

Primary Completion Date

Mar 31, 2025Estimated

Completion Date

Mar 31, 2026Estimated

First Submitted Date

May 19, 2020

First Submission Date that Met QC Criteria

May 26, 2020

First Posted Date

May 27, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 3, 2020

Last Update Posted Date

Jun 4, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ME/CFS patients		Patients diagnosed according to Canada Criteria 2003	Diagnostic Test: MRI Procedure: Spinal Tap
Healthy Controls		Age and sex matched healthy controls	Diagnostic Test: MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI	Diagnostic Test	If possible with spectroscopy	Healthy Controls ME/CFS patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalance of cervical obstructions	MRI findings	Two days
Prevalence of Intracranial Hypertension	CSF measurements	Two days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Diagnoses with ME/CFS and healthy controls

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Björn Bragee, MD	Contact	0854588875		bjorn@bragee.se
Bo C Bertilson, MD PhD	Contact	int4670732023		bo.bertilson@ki.se

Overall Officials

Name	Affiliation	Role
Björn Bragee, MD	Medect Clinical Trials	Study Chair

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Will be shared to other researchers with ethical approvement

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Time Frame

After completed study or published results and 3 years thereafter

Access Criteria

Researchers with that have ethical approvement.

URL

http://www.bragee.se/research

Condition Browse Module

MeSH Terms

ID	Term
D015673	Fatigue Syndrome, Chronic

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D004679	Encephalomyelitis
D000090862	Neuroinflammatory Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013129	Spinal Puncture

Ancestor Terms

ID	Term
D001706	Biopsy
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided