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

Multiple Sclerosis Clinical Trial

— BRAVE-DREAMS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01371760
• Other study ID #: S. Anna Hospital
• Status: Completed
• Phase: N/A
• First received: June 7, 2011
• Last updated: December 16, 2015
• Start date: August 2012
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: S. Anna Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Regione Emilia Romagna: Italy
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis
• Venous Insufficiency

Intervention

Procedure:
• Venous PTA
PTA of the internal jugular and/or azygous vein

Other:
• Catheter Venography
The patients will undergo catheter venography but not PTA

Locations

Country	Name	City	State
Italy	S. Anna Hospital	Ferrara	Fe
Italy	S. Anna Hospital, University of Ferrara, Ferrara, Italy	Ferrara

Sponsors (2)

Lead Sponsor	Collaborator
S. Anna Hospital	Regione Emilia-Romagna

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	EDSS	EDSS will be assessed along 1 year follow-up.	Baseline; 12 months	No
Secondary	Chronic fatigue	This highly disabling symptom completely orphan of effective therapy will be measured by M-FIS (Modified-Fatigue Impact Scale).	Baseline; 12 months	No
Secondary	Cognitive function	Cognitive functions will be measured by the means of MoCA mental state questionnaire.	Baseline; 12 months	Yes
Secondary	Annualized relapse rate	In the sub population affected by the RR clinical form the number of relapse will be assessed.	Baseline; 12 months	No
Secondary	Patency rate	The rate of successful PTA will be assessed by the means of postoperative Doppler sonography.	Baseline; 12 months	No
Secondary	Emotional status	Anxiety and Depression Scale for use with multiple sclerosis patients will be administered.	Baseline; 1 year	No
Secondary	Memory and cognition	The assessment will be performed by the means of PASAT - Paced Auditory Serial Addition Test	Baseline; 1 year	No
Secondary	Overactive Bladder	Overactive Bladder symptom will be measured by the means of validated Overactive Bladder Questionnaire-b.	Baseline; 1 year	No

External Links

•   Link