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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 212
- Locations
- 4
- Primary Endpoint
- Clinical parameters in an integrated functional score
Study Overview
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.
Detailed Description
Safety will be assessed by measuring serious and minor adverse effects related to treatment.
Effectiveness will be assessed by measuring 2 primary endpoints:
- 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.
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients affected by CCSVI associated with MS
- •relapsing-remitting and\or secondary progressive
- •18-65 years old
- •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
Outcomes
Primary Outcomes
Clinical parameters in an integrated functional score
Time Frame: Baseline; 12 months
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.
MRI outcome measures: T1Gad active lesion.T2 lesion volume MRI evaluation.
Time Frame: Baseline; 12 months
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.
Secondary Outcomes
- 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)
- Emotional status(Baseline; 1 year)
- Memory and cognition(Baseline; 1 year)
- Overactive Bladder(Baseline; 1 year)
Investigators
Paolo Zamboni
PI
S. Anna Hospital