Efficacy and Safety of Bilateral Cervical Lymphatic-Venous Anastomosis in the Treatment of Multiple System Atrophy
NCT ID: NCT07036939
Last Updated: 2025-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
46 participants
INTERVENTIONAL
2025-07-01
2028-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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).
Immediate LVA
Bilateral cervical lymphatic-venous anastomosis (LVA) performed within 2 weeks after baseline assessments.
Delayed LVA Group
Identical LVA procedure performed at 6 months (±2 weeks) post-baseline
Delayed LVA
Identical LVA procedure performed at 6 months (±2 weeks) post-baseline
Interventions
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Immediate LVA
Bilateral cervical lymphatic-venous anastomosis (LVA) performed within 2 weeks after baseline assessments.
Delayed LVA
Identical LVA procedure performed at 6 months (±2 weeks) post-baseline
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
70 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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Shengdi Chen
Professor
Locations
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Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Other Identifiers
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2025-264
Identifier Type: -
Identifier Source: org_study_id
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