Efficacy and Safety of Bilateral Cervical Lymphatic-Venous Anastomosis in the Treatment of Multiple System Atrophy

Обзор

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.

Вмешательства

• Процедура Immediate LVA
  Bilateral cervical lymphatic-venous anastomosis (LVA) performed within 2 weeks after baseline assessments.
• Процедура Delayed LVA
  Identical LVA procedure performed at 6 months (±2 weeks) post-baseline

Первичные конечные точки

• Efficacy of Bilateral LVA on MSA Symptoms at 3 Months (UMSARS-II Score Change) [Срок оценки: Baseline to 3 months post-operation.]
• Safety of Bilateral LVA (Surgical Adverse Events) [Срок оценки: Intraoperative to 3 months post-operation.]

Вторичные конечные точки (6)

• Long-term Efficacy of LVA on MSA Symptoms [Срок оценки: Baseline to 6, 9, and 12 months post-operation.]
• Effect of LVA on Plasma Biomarkers [Срок оценки: Baseline to 3 months post-operation.]
• Assessment of Glymphatic Function via MRI ALPS Index [Срок оценки: Preoperatively (baseline)，3 months post-LVA，12 months post-LVA]
• Cognitive Improvement Post-LVA [Срок оценки: Baseline to 3, 6, 9, and 12 months post-operation.]
• Quality of Life Improvement [Срок оценки: Baseline to 3, 6, 9, and 12 months post-operation.]
• Disease-Modifying Effect of LVA (Delayed vs. Immediate Surgery) [Срок оценки: Baseline， 3 Months，6 Months，9Months，and 12 Months]

Критерии участия

Критерии включения

• 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 ≤3.
• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Шанхай

Идентификаторы

NCT: NCT07036939 · 2025-264

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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