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BRAVE-DREAMS (BRAin VEnous DRainage Exploited Against Multiple Sclerosis) (BRAVE-DREAMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01371760
Recruitment Status : Completed
First Posted : June 13, 2011
Last Update Posted : December 17, 2015
Regione Emilia-Romagna
Information provided by (Responsible Party):
Paolo Zamboni, S. Anna Hospital

Tracking Information
First Submitted Date  ICMJE June 7, 2011
First Posted Date  ICMJE June 13, 2011
Last Update Posted Date December 17, 2015
Study Start Date  ICMJE August 2012
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2011)
  • Clinical parameters in an integrated functional score [ Time Frame: Baseline; 12 months ]
    Five neurological parameters will be measured by the means of proper validated tools along 1 year of follow-up. The evaluation leads to a score, respectively expressed as improved, stable, fluctuant, worsened.
  • MRI outcome measures: T1Gad active lesion.T2 lesion volume MRI evaluation. [ Time Frame: Baseline; 12 months ]
    Standard MRI parameters will be assessed by the means of a blinded centre of lecture. Outcome measurement will be performed at baseline, 6 months and at 1 year follow-up.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2011)
  • EDSS [ Time Frame: Baseline; 12 months ]
    EDSS will be assessed along 1 year follow-up.
  • Chronic fatigue [ Time Frame: Baseline; 12 months ]
    This highly disabling symptom completely orphan of effective therapy will be measured by M-FIS (Modified-Fatigue Impact Scale).
  • Cognitive function [ Time Frame: Baseline; 12 months ]
    Cognitive functions will be measured by the means of MoCA mental state questionnaire.
  • Annualized relapse rate [ Time Frame: Baseline; 12 months ]
    In the sub population affected by the RR clinical form the number of relapse will be assessed.
  • Patency rate [ Time Frame: Baseline; 12 months ]
    The rate of successful PTA will be assessed by the means of postoperative Doppler sonography.
  • Emotional status [ Time Frame: Baseline; 1 year ]
    Anxiety and Depression Scale for use with multiple sclerosis patients will be administered.
  • Memory and cognition [ Time Frame: Baseline; 1 year ]
    The assessment will be performed by the means of PASAT - Paced Auditory Serial Addition Test
  • Overactive Bladder [ Time Frame: Baseline; 1 year ]
    Overactive Bladder symptom will be measured by the means of validated Overactive Bladder Questionnaire-b.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE BRAVE-DREAMS (BRAin VEnous DRainage Exploited Against Multiple Sclerosis)
Official Title  ICMJE Randomized Multi-centered Study for Evaluating the Efficacy and Safety of Angioplastic Surgery of the Extracranial Veins in the Treatment of Multiple Sclerosis. Studio Randomizzato Multicentrico Per la Valutazione Dell'Efficacia e Sicurezza Dell'Intervento di Disostruzione Delle Vene Extracraniche Nel Trattamento Della Sclerosi Multipla
Brief Summary

To assess in a double blinded randomized control trial (RCT) study design safety and effectiveness of balloon angioplasty of the main extracranial and extravertebral veins in multiple sclerosis (MS) associated to chronic cerebrospinal venous insufficiency (CCSVI).

Mean follow-up 1 year. 5-8 Italian centres 360 relapsing remitting (RR) MS patients will be randomized, with expanded disability disease scale (EDSS) ranging 2-5.5, age 18-65.

Detailed Description

Safety will be assessed by measuring serious and minor adverse effects related to treatment.

Effectiveness will be assessed by measuring 2 primary endpoints:

  1. Clinical parameters will be expressed in an integrated functional measure leading to the score, respectively, of improved, stable, worsened. Functional assessment is performed by tools permitting a quantification and will be made by a team of independent assessors. Clinical instrumental evaluation will be performed at baseline, and subsequently on 3 months basis. The outcome parameters leading to the composite functional measure are instrumental parameters, less assessor dependent, singularly validated for measuring the disability in MS. They are the followings: A) Dynamic Balance Assessment: Balance Master Limits of Stability (LOS). In static platform, swinging to reach the set position of center of pressure. B) Walking Function: The subject walks spontaneously for 10 meters with chronometric measure of time counting the number of steps. The test calculates the walk ratio i.e. ratio between length and step frequency. C) Manual dexterity. Box & Block test, moving wooden cubes. D) Sphincter control: Post-voiding residual by ultrasounds. F) Visual acuity: Low-contrast visual acuity Sloan Letter Chart.
  2. Magnetic Resonance Imaging (MRI) outcome measures: T1Gad active lesion.T2 lesion volume MRI evaluation at baseline, 6, 12 months.

Secondary endpoints are: EDSS, chronic fatigue, cognitive function, rate of restenosis, annualized relapse rate.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Multiple Sclerosis
  • Venous Insufficiency
Intervention  ICMJE
  • Procedure: Venous PTA
    PTA of the internal jugular and/or azygous vein
  • Other: Catheter Venography
    The patients will undergo catheter venography but not PTA
Study Arms  ICMJE
  • Experimental: Intervention
    The patients will undergo PTA of the extracranial cerebral veins
    Intervention: Procedure: Venous PTA
  • Sham Comparator: Controls
    The patients will undergo sham procedure
    Intervention: Other: Catheter Venography
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 16, 2015)
Original Estimated Enrollment  ICMJE
 (submitted: June 10, 2011)
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients affected by CCSVI associated with MS
  • relapsing-remitting and\or secondary progressive
  • 18-65 years old
  • EDSS 2-5
  • disease duration < 10y
  • No relapse in the 30 days preceding the procedure
  • clinical stability in the last 6 months with disease mod. treatments
  • Patients under the best available therapy

Exclusion Criteria:

  • patients previously treated for CCSVI or inserted in other clinical trials in the last 3 months
  • under treatment with natalizumab
  • pregnant or refusing to adopt contraception
  • presence of significant comorbidities
  • alcool-drug abuse
  • thrombophilia
  • contraindication to MR
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01371760
Other Study ID Numbers  ICMJE S. Anna Hospital
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Data analysis on behalf of the independent Biostatistic Center will be completed within May 2016
Responsible Party Paolo Zamboni, S. Anna Hospital
Study Sponsor  ICMJE S. Anna Hospital
Collaborators  ICMJE Regione Emilia-Romagna
Investigators  ICMJE
Principal Investigator: Paolo Zamboni, MD S. Anna Hospital, University of Ferrara, Ferrara, Italy
Study Chair: Graziella Filippini, MD Istituto Neurologico Besta, Milano, Italy
PRS Account S. Anna Hospital
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP