Efficacy and Safety of Bilateral Cervical Lymphatic-Venous Anastomosis in the Treatment of Multiple System Atrophy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Immediate LVA, Delayed LVA.
- Who it may be relevant to
- Registry conditions: Multiple System Atrophy. Basic parameters: 40 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure Immediate LVA
Bilateral cervical lymphatic-venous anastomosis (LVA) performed within 2 weeks after baseline assessments. - Procedure Delayed LVA
Identical LVA procedure performed at 6 months (±2 weeks) post-baseline
Primary outcome measures
- Efficacy of Bilateral LVA on MSA Symptoms at 3 Months (UMSARS-II Score Change) [Time frame: Baseline to 3 months post-operation.]
- Safety of Bilateral LVA (Surgical Adverse Events) [Time frame: Intraoperative to 3 months post-operation.]
Secondary outcome measures (6)
- Long-term Efficacy of LVA on MSA Symptoms [Time frame: Baseline to 6, 9, and 12 months post-operation.]
- Effect of LVA on Plasma Biomarkers [Time frame: Baseline to 3 months post-operation.]
- Assessment of Glymphatic Function via MRI ALPS Index [Time frame: Preoperatively (baseline)，3 months post-LVA，12 months post-LVA]
- Cognitive Improvement Post-LVA [Time frame: Baseline to 3, 6, 9, and 12 months post-operation.]
- Quality of Life Improvement [Time frame: Baseline to 3, 6, 9, and 12 months post-operation.]
- Disease-Modifying Effect of LVA (Delayed vs. Immediate Surgery) [Time frame: Baseline， 3 Months，6 Months，9Months，and 12 Months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai
Identifiers
NCT: NCT07036939 · 2025-264