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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

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Venous Insufficiency Procedure: Venous PTA Other: Catheter Venography Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: Intervention
The patients will undergo PTA of the extracranial cerebral veins
Procedure: Venous PTA
PTA of the internal jugular and/or azygous vein

Sham Comparator: Controls
The patients will undergo sham procedure
Other: Catheter Venography
The patients will undergo catheter venography but not PTA

Primary Outcome Measures :
  1. 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.

  2. 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.

Secondary Outcome Measures :
  1. EDSS [ Time Frame: Baseline; 12 months ]
    EDSS will be assessed along 1 year follow-up.

  2. 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).

  3. Cognitive function [ Time Frame: Baseline; 12 months ]
    Cognitive functions will be measured by the means of MoCA mental state questionnaire.

  4. 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.

  5. Patency rate [ Time Frame: Baseline; 12 months ]
    The rate of successful PTA will be assessed by the means of postoperative Doppler sonography.

  6. Emotional status [ Time Frame: Baseline; 1 year ]
    Anxiety and Depression Scale for use with multiple sclerosis patients will be administered.

  7. Memory and cognition [ Time Frame: Baseline; 1 year ]
    The assessment will be performed by the means of PASAT - Paced Auditory Serial Addition Test

  8. Overactive Bladder [ Time Frame: Baseline; 1 year ]
    Overactive Bladder symptom will be measured by the means of validated Overactive Bladder Questionnaire-b.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01371760

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S. Anna Hospital
Ferrara, Fe, Italy, 44100
S. Anna Hospital, University of Ferrara, Ferrara, Italy
Ferrara, Italy, 44100
Sponsors and Collaborators
S. Anna Hospital
Regione Emilia-Romagna
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Principal Investigator: Paolo Zamboni, MD S. Anna Hospital, University of Ferrara, Ferrara, Italy
Study Chair: Graziella Filippini, MD Istituto Neurologico Besta, Milano, Italy
Additional Information:
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Paolo Zamboni, PI, S. Anna Hospital Identifier: NCT01371760    
Other Study ID Numbers: S. Anna Hospital
First Posted: June 13, 2011    Key Record Dates
Last Update Posted: December 17, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data analysis on behalf of the independent Biostatistic Center will be completed within May 2016
Keywords provided by Paolo Zamboni, S. Anna Hospital:
Multiple sclerosis
Chronic cerebrospinal venous insufficiency
Percutaneous Transluminal Angioplasty (PTA)
Internal jugular vein
Azygous vein
Additional relevant MeSH terms:
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Multiple Sclerosis
Venous Insufficiency
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Vascular Diseases
Cardiovascular Diseases