BRAVE-DREAMS (BRAin VEnous DRainage Exploited Against Multiple Sclerosis)
NCT ID: NCT01371760
Last Updated: 2015-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
212 participants
INTERVENTIONAL
2012-08-31
2015-12-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Intervention
The patients will undergo PTA of the extracranial cerebral veins
Venous PTA
PTA of the internal jugular and/or azygous vein
Controls
The patients will undergo sham procedure
Catheter Venography
The patients will undergo catheter venography but not PTA
Interventions
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Venous PTA
PTA of the internal jugular and/or azygous vein
Catheter Venography
The patients will undergo catheter venography but not PTA
Eligibility Criteria
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Inclusion Criteria
* 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
* under treatment with natalizumab
* pregnant or refusing to adopt contraception
* presence of significant comorbidities
* alcool-drug abuse
* thrombophilia
* contraindication to MR
18 Years
65 Years
ALL
No
Sponsors
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Regione Emilia-Romagna
OTHER
S. Anna Hospital
OTHER
Responsible Party
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Paolo Zamboni
PI
Principal Investigators
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Paolo Zamboni, MD
Role: PRINCIPAL_INVESTIGATOR
S. Anna Hospital, University of Ferrara, Ferrara, Italy
Graziella Filippini, MD
Role: STUDY_CHAIR
Istituto Neurologico Besta, Milano, Italy
Locations
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S. Anna Hospital
Ferrara, Fe, Italy
S. Anna Hospital, University of Ferrara, Ferrara, Italy
Ferrara, , Italy
Countries
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References
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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.
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.
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.
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.
Related Links
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Related Info
Other Identifiers
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S. Anna Hospital
Identifier Type: -
Identifier Source: org_study_id