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.
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.
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.
ALS patients meet to the inclusion and exclusion criteria
Case-crossover
Prospective
Deep cervical lymph node-vein bypass surgery
Procedure/SurgeryDeep cervical lymph node-vein bypass surgery, connecting deep cervical lymph node input lymphatic vessel
ALSFRS-R scale
Improvement of ALSFRS-R scale
Cognitive and Behavioral Scale (CAS)
Improvement of CAS score
Baseline of slow vital capacity (SVC)
Change baseline of SVC
Evaluation of glymphatic and meningeal lymphatic drainage
MRI evaluation of glymphatic and meningeal lymphatic drainage
Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-5)
Changes from baseline in the Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-5)
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