Multiple System AtrophyNCT07036939
Efficacy and Safety of Bilateral Cervical Lymphatic-Venous Anastomosis in the Treatment of Multiple System Atrophy
A study testing Immediate LVA and Delayed LVA in people with Multiple System Atrophy, run by Ruijin Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Multiple System Atrophy
- What is being tested?
- Immediate LVA and Delayed LVA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
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.
- Conditions
- Multiple System Atrophy
- Being tested
- Immediate LVA, Delayed LVA
- Keywords
- Multiple system atrophy, glymphatic system, lymphatic-venous anastomosis
- Medical subject headings
- Multiple System Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate LVAProcedure or surgery
Bilateral cervical lymphatic-venous anastomosis (LVA) performed within 2 weeks after baseline assessments.
Delayed LVAProcedure or surgery
Identical LVA procedure performed at 6 months (±2 weeks) post-baseline
| Study group | Role | What they receive |
|---|---|---|
| Immediate LVA group | Experimental | Participants will undergo bilateral cervical lymphatic-venous anastomosis (LVA) surgery within 2 weeks after baseline assessments (including clinical scales, biomarker testing, and neuroimaging). Receives: Procedure: Immediate LVA |
| Delayed LVA Group | Active comparator | Identical LVA procedure performed at 6 months (±2 weeks) post-baseline Receives: Procedure: Delayed LVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Bilateral LVA on MSA Symptoms at 3 Months (UMSARS-II Score Change)
Description:
Change in Unified Multiple System Atrophy Rating Scale Part II (UMSARS-II) scores from baseline to 3 months post-LVA surgery.
Scale Range: 0-56 (higher scores = worse motor function). Metric: Mean difference in total score.
Measured: Baseline to 3 months post-operation.
Safety of Bilateral LVA (Surgical Adverse Events)
Incidence of surgery-related adverse events (e.g., infection, bleeding, anastomosis failure) within 3 months post-operation.
Metric: Percentage of participants with ≥1 adverse event (AE).
Measured: Intraoperative to 3 months post-operation.
Secondary outcomes (6)
Long-term Efficacy of LVA on MSA Symptoms
Change in UMSARS-II scores from baseline to 6, 9, and 12 months post-LVA. Scale Range: 0-56 (higher = worse). Metric: Mean difference at each timepoint.
Measured: Baseline to 6, 9, and 12 months post-operation.
Effect of LVA on Plasma Biomarkers
Change in plasma biomarkers from baseline to 3 months post-LVA. Metric: Concentration (pg/mL) via ELISA.
Measured: Baseline to 3 months post-operation.
Assessment of Glymphatic Function via MRI ALPS Index
Assessment of Glymphatic Function via MRI ALPS Index Glymphatic activity will be quantitatively evaluated using Diffusion Tensor Imaging along the Perivascular Space (DTI-ALPS) sequence on 3T MRI. The ALPS index will be calculated from diffusivity ratios (Dx/Dz) in the perivascular spaces of deep white matter (centrum semiovale level), reflecting interstitial fluid clearance efficiency. Higher ALPS indices indicate enhanced glymphatic function.
Measured: Preoperatively (baseline)，3 months post-LVA，12 months post-LVA
Cognitive Improvement Post-LVA
Change in Montreal Cognitive Assessment (MoCA) scores from baseline to 3/6/9/12 months.
Scale Range: 0-30 (higher = better cognition).
Measured: Baseline to 3, 6, 9, and 12 months post-operation.
Quality of Life Improvement
Change in Parkinson's Disease Questionnaire-39 (PDQ-39) scores from baseline to 3/6/9/12 months.
Scale Range: 0-100 (lower = better QoL).
Measured: Baseline to 3, 6, 9, and 12 months post-operation.
Disease-Modifying Effect of LVA (Delayed vs. Immediate Surgery)
Differences in Unified Multiple System Atrophy Rating Scale Part II (UMSARS-II) Changes from Baseline to 3 Months，6 Months，9Months，and 12 Months
Measured: Baseline， 3 Months，6 Months，9Months，and 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple System AtrophyStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shengdi Chen, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036939
- Sponsor's protocol ID
- 2025-264
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Bilateral Cervical Lymphatic-Venous Anastomosis in the Treatment of Multiple System Atrophy
- ClinicalTrials.gov ID
- NCT07036939
- Acronym / sponsor ID
- 2025-264
- Conditions
- Multiple System Atrophy
- Keywords
- Multiple system atrophy, glymphatic system, lymphatic-venous anastomosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate LVA group | Experimental | Procedure: Immediate LVAParticipants will undergo bilateral cervical lymphatic-venous anastomosis (LVA) surgery within 2 weeks after baseline assessments (including clinical scales, biomarker testing, and neuroimaging). |
| Delayed LVA Group | Active comparator | Procedure: Delayed LVAIdentical LVA procedure performed at 6 months (±2 weeks) post-baseline |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate LVABilateral cervical lymphatic-venous anastomosis (LVA) performed within 2 weeks after baseline assessments. | Procedure or surgery | Immediate LVA group |
| Delayed LVAIdentical LVA procedure performed at 6 months (±2 weeks) post-baseline | Procedure or surgery | Delayed LVA Group |
Primary outcome
Efficacy of Bilateral LVA on MSA Symptoms at 3 Months (UMSARS-II Score Change)
Time frame: Baseline to 3 months post-operation.
Description: Change in Unified Multiple System Atrophy Rating Scale Part II (UMSARS-II) scores from baseline to 3 months post-LVA surgery. Scale Range: 0-56 (higher scores = worse motor function). Metric: Mean difference in total score.
Safety of Bilateral LVA (Surgical Adverse Events)
Time frame: Intraoperative to 3 months post-operation.
Incidence of surgery-related adverse events (e.g., infection, bleeding, anastomosis failure) within 3 months post-operation. Metric: Percentage of participants with ≥1 adverse event (AE).
6 secondary outcomes
Long-term Efficacy of LVA on MSA Symptoms
Time frame: Baseline to 6, 9, and 12 months post-operation.
Effect of LVA on Plasma Biomarkers
Time frame: Baseline to 3 months post-operation.
Assessment of Glymphatic Function via MRI ALPS Index
Time frame: Preoperatively (baseline)，3 months post-LVA，12 months post-LVA
Cognitive Improvement Post-LVA
Time frame: Baseline to 3, 6, 9, and 12 months post-operation.
Quality of Life Improvement
Time frame: Baseline to 3, 6, 9, and 12 months post-operation.
Disease-Modifying Effect of LVA (Delayed vs. Immediate Surgery)
Time frame: Baseline， 3 Months，6 Months，9Months，and 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Multiple System Atrophy
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 2
A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy
Multiple System Atrophy
RecruitingPhase 1/2
Tributyrin for Progressive Supranuclear Palsy (PSP): Virtual Trial
Parkinson Disease, Multiple System Atrophy
RecruitingObservational study
A Study of Risdiplam in Participants With Type I and Type II Spinal Muscle Atrophy (SMA)
Spinal Muscle Atrophy
RecruitingObservational study
Comparison of Individuals With Primary Ciliary Dyskinesia and Healthy Controls
Primary Ciliary Dyskinesia (PCD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate LVA and Delayed LVA in people with Multiple System Atrophy, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shengdi Chen, MD, PhD (+86 13818018166, chensd@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.