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

NCT01371760 | Completed DMC

• 1 other identifier: S. Anna Hospital
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 2

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.

Conditions

Multiple Sclerosis; Venous Insufficiency

Keywords

Multiple sclerosis; Chronic cerebrospinal venous insufficiency; Percutaneous Transluminal Angioplasty (PTA); Internal jugular vein; Azygous vein

Outcome Measures

Primary Outcomes (2)

• Clinical parameters in an integrated functional score

  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.

  Baseline; 12 months

• MRI outcome measures: T1Gad active lesion.T2 lesion volume MRI evaluation.

  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.

  Baseline; 12 months

Secondary Outcomes (8)

• EDSS

  Baseline; 12 months

• Chronic fatigue

  Baseline; 12 months

• Cognitive function

  Baseline; 12 months

• Annualized relapse rate

  Baseline; 12 months

• Patency rate

  Baseline; 12 months

Study Arms (2)

Intervention

EXPERIMENTAL

The patients will undergo PTA of the extracranial cerebral veins

Procedure: Venous PTA

Controls

SHAM COMPARATOR

The patients will undergo sham procedure

Other: Catheter Venography

Interventions

Venous PTA PROCEDURE

PTA of the internal jugular and/or azygous vein

Intervention

Catheter Venography OTHER

The patients will undergo catheter venography but not PTA

Controls

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients affected by CCSVI associated with MS
• relapsing-remitting and\\or secondary progressive
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• S. Anna Hospital: lead
• Regione Emilia-Romagna: collaborator

Study Sites (2)

S. Anna Hospital

Ferrara, Fe, 44100, Italy

Location

S. Anna Hospital, University of Ferrara, Ferrara, Italy

Ferrara, 44100, Italy

Location

Related Publications (4)

• Zamboni P, Galeotti R, Menegatti E, Malagoni AM, Gianesini S, Bartolomei I, Mascoli F, Salvi F. A prospective open-label study of endovascular treatment of chronic cerebrospinal venous insufficiency. J Vasc Surg. 2009 Dec;50(6):1348-58.e1-3. doi: 10.1016/j.jvs.2009.07.096.

  PMID: 19958985 RESULT

• Zamboni P, Galeotti R, Salvi F, Giaquinta A, Setacci C, Alborino S, Guzzardi G, Sclafani SJ, Maietti E, Veroux P; Brave Dreams Research Group. Effects of Venous Angioplasty on Cerebral Lesions in Multiple Sclerosis: Expanded Analysis of the Brave Dreams Double-Blind, Sham-Controlled Randomized Trial. J Endovasc Ther. 2020 Feb;27(1):1526602819890110. doi: 10.1177/1526602819890110. Epub 2019 Nov 17.

  PMID: 31735108 DERIVED

• Zamboni P, Tesio L, Galimberti S, Massacesi L, Salvi F, D'Alessandro R, Cenni P, Galeotti R, Papini D, D'Amico R, Simi S, Valsecchi MG, Filippini G; Brave Dreams Research Group. Efficacy and Safety of Extracranial Vein Angioplasty in Multiple Sclerosis: A Randomized Clinical Trial. JAMA Neurol. 2018 Jan 1;75(1):35-43. doi: 10.1001/jamaneurol.2017.3825.

  PMID: 29150995 DERIVED

• Zamboni P, Bertolotto A, Boldrini P, Cenni P, D'Alessandro R, D'Amico R, Del Sette M, Galeotti R, Galimberti S, Liberati A, Massacesi L, Papini D, Salvi F, Simi S, Stella A, Tesio L, Valsecchi MG, Filippini G; Chair of the Steering Committee. Efficacy and safety of venous angioplasty of the extracranial veins for multiple sclerosis. Brave dreams study (brain venous drainage exploited against multiple sclerosis): study protocol for a randomized controlled trial. Trials. 2012 Oct 3;13:183. doi: 10.1186/1745-6215-13-183.

  PMID: 23034121 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Multiple Sclerosis; Venous Insufficiency

Condition Hierarchy (Ancestors)

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

Study Officials

• Paolo Zamboni, MD

  S. Anna Hospital, University of Ferrara, Ferrara, Italy

  PRINCIPAL INVESTIGATOR

• Graziella Filippini, MD

  Istituto Neurologico Besta, Milano, Italy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: June 7, 2011
• First Posted: June 13, 2011
• Study Start: August 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: December 17, 2015

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will share

Locations

IT (2)