ClinicalTrials.gov record NCT07036939

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 7, 2026

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

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Age40 years old to 70 years old
SexAll
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This randomized study tests a surgical procedure (bilateral cervical lymphatic-venous anastomosis, LVA) in people with clinically established Multiple System Atrophy (MSA). Participants are assigned to receive LVA immediately or after a 6-month delay and will have clinical assessments, blood biomarker tests, and MRI before and after surgery. The study measures motor symptoms, cognitive and quality-of-life scores, MRI measures of glymphatic function, blood biomarkers, and surgical safety (primary safety outcome through 3 months), with other clinical measures followed up to 12 months.

What it is studying. The study investigates whether connecting deep cervical lymphatics to veins (bilateral LVA) changes clinical outcomes or safety in people with MSA, and whether any changes are linked to improved intracranial lymphatic drainage and clearance of pathological α-Syn protein in the brain.

What the researchers hope to learn. Determine short-term and long-term effects of bilateral LVA on motor function, autonomic symptoms, cognition, and quality of life in MSA. Assess surgical safety and the rate of surgery-related adverse events. Measure changes in plasma biomarkers and MRI ALPS index to evaluate whether LVA alters glymphatic drainage and α-Syn clearance. Compare outcomes between immediate versus delayed surgery to explore potential disease-modifying effects.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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 being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Procedure
  • Immediate LVA
  • Delayed LVA

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants are randomly assigned to have bilateral cervical lymphatic-venous anastomosis (LVA) surgery either soon after baseline (within 2 weeks) or delayed at about 6 months. They will have pre- and postoperative evaluations including clinical rating scales (UMSARS), cognitive testing (MoCA), quality-of-life questionnaires (PDQ-39), blood sample collection for biomarker tests, and brain MRI scans including DTI-ALPS to assess glymphatic function. Follow-up visits and assessments occur at multiple timepoints (for example 3, 6, 9, and 12 months) with monitoring for surgical adverse events (infection, bleeding, anastomosis issues) and other safety checks. The study involves an invasive surgical procedure (bilateral cervical LVA), repeated clinical assessments, MRI scans, and blood draws.

How the study is structured. Interventional, randomized, parallel-group study with single masking. Participants are assigned to two groups: one group has bilateral LVA within two weeks of baseline assessments, the other group has the same surgery at about 6 months. Clinical scales, blood biomarker testing, and MRI (including an ALPS index for glymphatic function) are collected before surgery and at multiple follow-up visits up to 12 months. Primary outcomes include change in UMSARS-II motor score at 3 months and incidence of surgery-related adverse events within 3 months.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on multiple system atrophy

Clinical trials76 trials listed for multiple system atrophyEvery trial the registry lists for multiple system atrophy, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in multiple system atrophy researchLatest monthly update: September 2026. Includes: Tube feeding. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jul 1, 2025 (estimated)
Primary completion
Apr 30, 2028 (estimated)
Study completion
Apr 30, 2028 (estimated)
Target enrollment
46 participants (estimated)
Last updated on registry
Jun 25, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Ruijin Hospital
Principal investigator
Shengdi Chen, Professor
Ruijin Hospital

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025 · China

Terms used on this page · explanations by MedicalUpdates.ai

biomarker
Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
MRI
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
biospecimens
A collection of biological samples, such as blood or tissue, stored with medical information so that researchers can study them later.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
life expectancy
Some studies require that, in the investigator's judgement, a participant is likely to live long enough to complete the study period. It is a study requirement, not a prediction about any individual.
Contraindications
A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

← Back to clinical trials