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Trial record 90 of 337 for:    Charcot Marie Tooth

Centralized Reading Assessment of Chronic CerebroSpinal Venous Insufficiency (CCSVI) in Patients With Multiple Sclerosis and Other Neurological Diseases

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ClinicalTrials.gov Identifier: NCT02308579
Recruitment Status : Completed
First Posted : December 4, 2014
Last Update Posted : February 12, 2016
Sponsor:
Collaborator:
University of Pavia
Information provided by (Responsible Party):
Robert Zivadinov, MD, PhD, University at Buffalo

Brief Summary:
This a retrospective, blinded trial in which collaborators in Italy will review the doppler findings from the Combined Transcranial and Extracranial Venous Doppler (CTEVD) trial in an attempt to measure reproducibility.

Condition or disease
Clinically Isolated Syndrome (CIS) Multiple Sclerosis (MS) Other Neurological Disorders (OND) Healthy (HC)

Detailed Description:

This study will retrospectively investigate doppler images from the second phase of the CTEVD trial.

  1. To determine the prevalence of CCSVI in patients with MS, compared with the prevalence observed in a control population consisting of Other Neurological Diseases (OND) patients and Healthy Controls (HC) by using blinded, controlled centralized ultrasound reading assessment of 5 Venous Haemodynamic (VH) CCSVI CCSVI Doppler UltraSound (CDUS) criteria.
  2. To investigate whether prevalence of CCSVI is different between centralized and local CDUS reading of 5 VH CCSVI CDUS criteria.
  3. To investigate the prevalence of CCSVI in patients with MS, compared with the prevalence observed in a control population consisting of OND patients and HC, when bidirectional flow in the intracranial veins and sinuses CDUS criterion is not considered as part of VH CCSVI CDUS criteria.
  4. To determine whether prevalence of CCSVI in patients with MS, compared with the prevalence observed in a control population consisting of OND patients and HC differs when using CDUS velocity and flow parameters in the Internal Jugular Veins (IJVs) and Vertebral Veins (VVs).
  5. To determine the reproducibility of VH criteria by using of centralized and local blinded, controlled CDUS reading assessment.

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Study Type : Observational
Actual Enrollment : 499 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Prevalence of Chronic Cerebrospinal Venous Insufficiency in Patients With Multiple Sclerosis and Other Neurological Diseases. An Ultrasound, Blinded, Case-Controlled, Centralized Reading Assessment
Study Start Date : July 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Group/Cohort
Multiple Sclerosis
Patients diagnosed with Multiple Sclerosis (MS), identified in the CTEVD trial
Clinically Isolated Syndrome
Patients diagnosed with Clinically Isolated Syndrome (CIS), identified in the CTEVD trial.
Other Neurological Disorders
Patients diagnosed with Other Neurological Disorders (OND), identified in the CTEVD trial. ONDs fall into one of four categories: Neurodegenerative, Vascular, Autoimmune, and Neuromuscular; and the following disorders: Acute Disseminated Encephalomyelitis (ADEM); Antiphospholipid Antibody (syndrome; APLA); Atypical, short-lasting neurodegenerative disease; Autoimmune disease not otherwise specified (NOS); Cerebellum Syndrome; Charcot-Marie Tooth Disease; Chiari Malformation; Chronic Fatigue Syndrome; Central Nervous System Vasculitis; Demyelinating Disease; Epilepsy; Headaches; Idiopathic Chronic Neuropathy; Migraines; Mitochondrial Disease; Myelopathy; Neurofibromatosis; Neuropathy; Optic Neuritis; Parasthesia related to Transient Ischemic Attacks (TIA); Parkinson's Disease; Restless legs syndrome; Seizures; Spinal Cerebellum Disease; Spinal Disc Degeneration; Syringomyelia; and Vertigo
Healthy Controls
Individuals who are healthy (i.e., free from neurological conditions; HC) , identified in the CTEVD trial.



Primary Outcome Measures :
  1. Number of MS (or CIS) and HC (or OND) who have 5 VH CCSVI CDUS criteria on doppler ultrasound [ Time Frame: Baseline ]
    The prevalence (number) of MS/CIS vs. HC/OND who fulfill the 5 venous haemodynamic (VH) criteria on doppler ultrasound.



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Ages Eligible for Study:   5 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants in this study will be those who had participated in the second phase of the Combined Transcranial/Extracranial Venous Deficiency (CTEVD) study.
Criteria

Inclusion Criteria:

  • Participation in the CTEVD Phase 2 study
  • Available CDUS exam
  • Diagnosed with CIS, MS, OND, or being a HC
  • Fulfilling inclusion criteria from the CTEVD study

Exclusion Criteria:

  • Not having an available CDUS exam
  • Diagnosed with Radiologically Isolated Syndrome (RIS) or Neuromyelitis Optic (NMO)
  • Fulfilling exclusion criteria from the CTEVD study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02308579


Sponsors and Collaborators
University at Buffalo
University of Pavia
Investigators
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Principal Investigator: Robert Zivadinov, MD, PhD University at Buffalo

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Responsible Party: Robert Zivadinov, MD, PhD, Professor of Neurology, University at Buffalo
ClinicalTrials.gov Identifier: NCT02308579     History of Changes
Other Study ID Numbers: CDUS1
First Posted: December 4, 2014    Key Record Dates
Last Update Posted: February 12, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Multiple Sclerosis
Venous Insufficiency
Sclerosis
Nervous System Diseases
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Vascular Diseases
Cardiovascular Diseases