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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 212
- 试验地点
- 4
- 主要终点
- Clinical parameters in an integrated functional score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Clinical parameters in an integrated functional score
时间窗: 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.
时间窗: 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.
次要结局
- 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)
研究者
Paolo Zamboni
PI
S. Anna Hospital