Efficacy and Safety of Deep Cervical Lymph Node-vein Bypass Surgery in ALS Amyotrophic Lateral Sclerosis

NCT06351735 | Not Yet Recruiting

• 1 other identifier: 2024-0336
• Study Type: observational
• Target: 3
• Locations: 0 countries
• Sites: N/A

Brief Summary

Amyotrophic lateral sclerosis (ALS), a fatal neurodegenerative disease, affects motor neurons, causing progressive muscle atrophy and weakness. Current treatments are ineffective, with most patients dying within 3-5 years of diagnosis. The disease's exact cause is unclear, but factors such as oxidative stress and protein abnormalities are implicated. Abnormal protein deposits and neurotoxic factors in the brain and spinal cord contribute to ALS pathology. Recent research on the brain's glymphatic-lymphatic system suggests impaired waste clearance may exacerbate ALS. Restoring drainage connections between cervical lymphatic vessels and veins could potentially alleviate neurodegenerative disease progression.

Conditions

Efficacy and Safety

Keywords

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (2)

• ALSFRS-R scale

  Improvement of ALSFRS-R scale

  Pre-surgery and post-surgery 1month, 3 months, 6 months and 1 year

• Cognitive and Behavioral Scale (CAS)

  Improvement of CAS score

  Pre-surgery and post-surgery 1month, 3 months, 6 months and 1 year

Secondary Outcomes (3)

• Baseline of slow vital capacity (SVC)

  Pre-surgery and post-surgery 1month, 3 months, 6 months and 1 year

• Evaluation of glymphatic and meningeal lymphatic drainage

  Pre-surgery and post-surgery 3 months, 6 months and 1 year

• Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-5)

  Pre-surgery and post-surgery 3 months, 6 months and 1 year

Study Arms (1)

Surgery

Patients undergo deep cervical lymph node-vein bypass surgery

Procedure: Deep cervical lymph node-vein bypass surgery

Interventions

Deep cervical lymph node-vein bypass surgery PROCEDURE

Deep cervical lymph node-vein bypass surgery, connecting deep cervical lymph node input lymphatic vessel

Surgery

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ALS patients meet to the inclusion and exclusion criteria

You may qualify if:

• ①diagnosis of probable, clinically probable, clinically probable laboratory-supported, or clinically definite ALS according to the revised El Escorial World Federation of Neurology criteria; ② aged between 20 and 80 years old (inclusive); ③ ALS patients with King's Stage 3-4; ④ body weight not less than 45 kg and body mass index (BMI) not less than 18.0 kg/m2; 5) not currently receiving riluzole or receiving a stable dose of riluzole for at least 4 weeks before screening; Subjects who received riluzole were expected to maintain the same dose throughout the study; ⑦ Subjects' FVC≥60% predicted value after adjusting for sex, age, and height.

You may not qualify if:

• ① Refusal to participate; ② Unable to complete MRI scan; ③ significant cognitive impairment, mental illness, epilepsy or other neurodegenerative diseases, substance abuse; ④ recent severe infection or infectious diseases within 4 weeks; ⑤ complicated with other systemic underlying diseases; Any past stem cell or gene therapy for ALS.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Biospecimen

Retention: SAMPLES WITH DNA

Cerebrospinal fluid and blood

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Yuanjian Fang, Dr

CONTACT

86-18768109541; sandman0506@foxmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share