BRAVE-DREAMS (BRAin VEnous DRainage Exploited Against Multiple Scleros
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
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Venous PTA
Placebo
- Catheter Venography
What it measured
Main measures
Clinical parameters in an integrated functional score
Baseline; 12 months
MRI outcome measures: T1Gad active lesion.T2 lesion volume MRI evaluation.
Baseline; 12 months
MRI lesions
Other measures (8)
EDSS
Baseline; 12 months
Disability progressionChronic fatigue
Baseline; 12 months
FatigueCognitive function
Baseline; 12 months
Thinking and memoryAnnualized relapse rate
Baseline; 12 months
RelapsesPatency rate
Baseline; 12 months
Emotional status
Baseline; 1 year
Mood and sleepMemory and cognition
Baseline; 1 year
Thinking and memoryOveractive Bladder
Baseline; 1 year
Bladder, bowel and sexual function
Who could take part
Relapsing and progressive · 18 to 65 · EDSS 2 to 5
Show the full criteria
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
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
Results
Efficacy and Safety of Extracranial Vein Angioplasty in Multiple Sclerosis: A Randomized Clinical Trial.JAMA Neurol · 2018
Results
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
Results
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.
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History
Started
Aug 2012
Main results due
Dec 2014
Finished
Dec 2015