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

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Multiple System Atrophy

Treatments: Procedure: Delayed LVA; Procedure: Immediate LVA

Study type: Interventional

Funder types: Other

Identifiers

NCT07036939

2025-264

Details and patient eligibility

About

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.

Enrollment: 46 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 2 patient groups

Immediate LVA group

Experimental group

Description:

Participants will undergo bilateral cervical lymphatic-venous anastomosis (LVA) surgery within 2 weeks after baseline assessments (including clinical scales, biomarker testing, and neuroimaging).

Treatment:

Procedure: Immediate LVA

Delayed LVA Group

Active Comparator group

Description:

Identical LVA procedure performed at 6 months (±2 weeks) post-baseline

Treatment:

Procedure: Delayed LVA