Efficacy and Safety of Bilateral Cervical Lymphatic-Venous Anastomosis in the Treatment of Multiple System Atrophy
Launched by RUIJIN HOSPITAL · Jun 17, 2025
Trial Information
Current as of July 21, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new surgical procedure called bilateral cervical lymphatic-venous anastomosis (LVA) to see if it can help people with Multiple System Atrophy (MSA), a rare and serious brain disorder that affects movement, balance, and automatic body functions like blood pressure and bladder control. The surgery aims to improve the brain’s natural cleaning system by connecting certain lymphatic vessels in the neck to veins, which might help remove harmful proteins linked to MSA and slow down the disease.
People who may be eligible for this study are adults between 40 and 70 years old with a confirmed diagnosis of MSA, who have mild to moderate disability, and are healthy enough for surgery. Participants will have thorough tests before and after the surgery, including physical exams, brain scans, and blood tests, to track changes in their symptoms and quality of life. The study will also closely monitor safety to watch for any complications from the surgery. This research could offer a new, non-drug option to help manage MSA in the future.
Gender
ALL
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.
About Ruijin Hospital
Ruijin Hospital, affiliated with Shanghai Jiao Tong University School of Medicine, is a leading medical institution in China recognized for its commitment to advancing healthcare through innovative research and clinical trials. With a strong emphasis on patient-centered care, Ruijin Hospital integrates cutting-edge medical practices with rigorous scientific investigation. The hospital's multidisciplinary teams are dedicated to developing new therapeutic approaches, improving patient outcomes, and contributing to global medical knowledge. As a sponsor of clinical trials, Ruijin Hospital ensures adherence to the highest ethical standards and regulatory compliance, fostering an environment of collaboration and excellence in clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Shanghai, Shanghai, China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported