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

S. Anna Hospital

Status: Completed

Conditions: Multiple Sclerosis; Venous Insufficiency

Treatments: Procedure: Venous PTA; Other: Catheter Venography

Study type: Interventional

Funder types: Other

Identifiers

NCT01371760

S. Anna Hospital

Details and patient eligibility

About

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.

Full 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.

Enrollment: 212 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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212 participants in 2 patient groups

Intervention

Experimental group

Description:

The patients will undergo PTA of the extracranial cerebral veins

Treatment:

Procedure: Venous PTA

Controls

Sham Comparator group

Description:

The patients will undergo sham procedure

Treatment:

Other: Catheter Venography