<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04403854</url>
  </required_header>
  <id_info>
    <org_study_id>BRAGEE MEPRO</org_study_id>
    <nct_id>NCT04403854</nct_id>
  </id_info>
  <brief_title>Structural Problems in Brainstem and Cervical Spine Cord in ME/CFS</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bragee Clinics</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bragee Clinics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A case control study on patients with ME/CFS and healthy controls on prevalence of cervical&#xD;
      obstructions, Cerebro spinal fluid (CSF) pressure and laboratory findings.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      50 patients and 50 healthy controls will undergo clinical exams and blood test of&#xD;
      inflammatory and other findings as well as magnetic resonance imaging (MRI) with&#xD;
      spectroscopy. The patients will undergo csf -sampling and measurements of CSF pressure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">April 1, 2021</start_date>
  <completion_date type="Anticipated">March 31, 2026</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalance of cervical obstructions</measure>
    <time_frame>Two days</time_frame>
    <description>MRI findings</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of Intracranial Hypertension</measure>
    <time_frame>Two days</time_frame>
    <description>CSF measurements</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Chronic Fatigue Syndrome</condition>
  <arm_group>
    <arm_group_label>ME/CFS patients</arm_group_label>
    <description>Patients diagnosed according to Canada Criteria 2003</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Controls</arm_group_label>
    <description>Age and sex matched healthy controls</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>MRI</intervention_name>
    <description>If possible with spectroscopy</description>
    <arm_group_label>Healthy Controls</arm_group_label>
    <arm_group_label>ME/CFS patients</arm_group_label>
    <other_name>Cervical MRI, Brain MRI</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Spinal Tap</intervention_name>
    <description>together with CSF pressure estimate</description>
    <arm_group_label>ME/CFS patients</arm_group_label>
    <other_name>CFS sampling</other_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood, Cerebrospinal fluid&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Diagnoses with ME/CFS and healthy controls&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Diagnose Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) according to Canada&#xD;
        Consensus Criteria from 2003&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Bleeding abnormality Contraindication to Magnetic Resonance Imaging MRI Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Björn Bragee, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Medect Clinical Trials</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Björn Bragee, MD</last_name>
    <phone>0854588875</phone>
    <email>bjorn@bragee.se</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Bo C Bertilson, MD PhD</last_name>
    <phone>int4670732023</phone>
    <email>bo.bertilson@ki.se</email>
  </overall_contact_backup>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>June 3, 2020</last_update_submitted>
  <last_update_submitted_qc>June 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatigue Syndrome, Chronic</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Will be shared to other researchers with ethical approvement</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>After completed study or published results and 3 years thereafter</ipd_time_frame>
    <ipd_access_criteria>Researchers with that have ethical approvement.</ipd_access_criteria>
    <ipd_url>http://www.bragee.se/research</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04403854
org study id: BRAGEE MEPRO
nct id: NCT04403854
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Case-Control
time perspective: Prospective
measure: Prevalance of cervical obstructions
time frame: Two days
description: MRI findings
measure: Prevalence of Intracranial Hypertension
time frame: Two days
description: CSF measurements
arm group label: ME/CFS patients
description: Patients diagnosed according to Canada Criteria 2003
arm group label: Healthy Controls
description: Age and sex matched healthy controls
intervention type: Diagnostic Test
intervention name: MRI
description: If possible with spectroscopy
arm group label: Healthy Controls
arm group label: ME/CFS patients
other name: Cervical MRI, Brain MRI
intervention type: Procedure
intervention name: Spinal Tap
description: together with CSF pressure estimate
arm group label: ME/CFS patients
other name: CFS sampling
Blood, Cerebrospinal fluid
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Björn Bragee, MD
role: Study Chair
affiliation: Medect Clinical Trials
last name: Björn Bragee, MD
phone: 0854588875
email: bjorn@bragee.se
last name: Bo C Bertilson, MD PhD
phone: int4670732023
email: bo.bertilson@ki.se
responsible party type: Sponsor
mesh term: Fatigue Syndrome, Chronic
mesh term: Syndrome
mesh term: Fatigue
sharing ipd: Yes
ipd description: Will be shared to other researchers with ethical approvement
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: After completed study or published results and 3 years thereafter
ipd access criteria: Researchers with that have ethical approvement.
ipd url: http://www.bragee.se/research