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

NCT02308579 | Completed

• 1 other identifier: CDUS1
• Study Type: observational
• Target: 499
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Clinically Isolated Syndrome (CIS); Multiple Sclerosis (MS); Other Neurological Disorders (OND); Healthy (HC)

Outcome Measures

Primary Outcomes (1)

• Number of MS (or CIS) and HC (or OND) who have 5 VH CCSVI CDUS criteria on doppler ultrasound

  The prevalence (number) of MS/CIS vs. HC/OND who fulfill the 5 venous haemodynamic (VH) criteria on doppler ultrasound.

  Baseline

Study Arms (4)

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.

Eligibility Criteria

• Age: 5 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Not having an available CDUS exam
• Diagnosed with Radiologically Isolated Syndrome (RIS) or Neuromyelitis Optic (NMO)

Sponsors & Collaborators

• University at Buffalo: lead
• University of Pavia: collaborator

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Robert Zivadinov, MD, PhD

  University at Buffalo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: July 8, 2014
• First Posted: December 4, 2014
• Study Start: July 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: February 12, 2016

Record last verified: 2016-02