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

Sponsor
Ruijin Hospital
Study ID
NCT07036939
Status
Not Yet Recruiting

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Conditions

  • Multiple System Atrophy

Eligibility Criteria

Sex
ALL
Age
40 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Jun 25, 2025
Start date
Jul 1, 2025
Status verified
Jun 2025
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
46 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Immediate LVA group
    Participants will undergo bilateral cervical lymphatic-venous anastomosis (LVA) surgery within 2 weeks after baseline assessments (including clinical scales, biomarker testing, and neuroimaging).
  • Active Comparator: Delayed LVA Group
    Identical LVA procedure performed at 6 months (±2 weeks) post-baseline

Primary Outcome Measure

Efficacy of Bilateral LVA on MSA Symptoms at 3 Months (UMSARS-II Score Change) [ Time Frame: Baseline to 3 months post-operation. ]

Central Contacts

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