Efficacy and Safety of Bilateral Cervical Lymphatic-Venous Anastomosis in the Treatment of Multiple System Atrophy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Efficacy of Bilateral LVA on MSA Symptoms at 3 Months (UMSARS-II Score Change)
研究概览
简要总结
Multiple System Atrophy (MSA) is a rare and aggressive neurodegenerative disorder characterized by a combination of motor impairments, autonomic dysfunction, and cerebellar ataxia, with no currently available disease-modifying therapies. Emerging evidence suggests that impaired glymphatic clearance of pathological α-synuclein aggregates may contribute to disease progression. This clinical study investigates the potential of bilateral cervical lymphatic-venous anastomosis (LVA) - a microsurgical procedure connecting deep cervical lymphatics to veins - to enhance glymphatic drainage and slow disease progression in MSA patients.
This single-center prospective clinical study will enroll patients with clinically confirmed MSA to undergo bilateral cervical lymphatic-venous anastomosis (LVA). Through comprehensive pre- and postoperative evaluations including clinical scale assessments, blood biomarker testing, and neuroimaging examinations, the study aims to evaluate the short-term and long-term effects of bilateral LVA on patients' motor function, autonomic symptoms, and quality of life, as well as its potential to delay disease progression.
The study will further investigate whether the potential clinical improvements from LVA are mediated through enhanced intracranial lymphatic drainage function and subsequent clearance of pathological α-Syn protein in the brain. Safety assessments will include monitoring and recording both short-term and long-term postoperative complications. This research may provide a novel non-pharmacological intervention approach for MSA treatment.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets the 2022 Chinese Expert Consensus Diagnostic Criteria for Clinically Established Multiple System Atrophy (MSA).
- •Unified MSA Rating Scale Part IV (UMSARS-IV) global disability score ≤
- •Age: 40-70 years
- •ASA (American Society of Anesthesiologists) Physical Status Classification ≤III, indicating acceptable anesthesia risk.
- •Ability to complete neuropsychological assessments, physical examinations, brain MRI, and venous blood sampling.
- •Willing to participate, provide biospecimens, and sign informed consent.
排除标准
- •Cognitive/Psychiatric Disorders: Congenital intellectual disability or severe neurological/psychiatric disorders affecting compliance.
- •Severe Comorbidities: End-stage cardiac, hepatic, renal, or respiratory failure, or active malignancy with life expectancy <1 year.
- •Surgical Contraindications:
- •Coagulopathy (uncontrolled bleeding risk)
- •Allergy to surgical drugs/contrast agents
- •Active neck infection (skin/deep tissue)
- •Inability to adhere to study visits.
- •Participation in other competing clinical trials.
结局指标
主要结局
Efficacy of Bilateral LVA on MSA Symptoms at 3 Months (UMSARS-II Score Change)
时间窗: Baseline to 3 months post-operation.
Description: Change in Unified Multiple System Atrophy Rating Scale Part II (UMSARS-II) scores from baseline to 3 months post-LVA surgery. Scale Range: 0-56 (higher scores = worse motor function). Metric: Mean difference in total score.
Safety of Bilateral LVA (Surgical Adverse Events)
时间窗: Intraoperative to 3 months post-operation.
Incidence of surgery-related adverse events (e.g., infection, bleeding, anastomosis failure) within 3 months post-operation. Metric: Percentage of participants with ≥1 adverse event (AE).
次要结局
- Long-term Efficacy of LVA on MSA Symptoms(Baseline to 6, 9, and 12 months post-operation.)
- Effect of LVA on Plasma Biomarkers(Baseline to 3 months post-operation.)
- Assessment of Glymphatic Function via MRI ALPS Index(Preoperatively (baseline)，3 months post-LVA，12 months post-LVA)
- Cognitive Improvement Post-LVA(Baseline to 3, 6, 9, and 12 months post-operation.)
- Quality of Life Improvement(Baseline to 3, 6, 9, and 12 months post-operation.)
- Disease-Modifying Effect of LVA (Delayed vs. Immediate Surgery)(Baseline， 3 Months，6 Months，9Months，and 12 Months)