A Trial for Minimally Invasive Neurosurgery With AI-assisted Robotic Guidance for Moderate Basal Ganglia Hemorrhage (RAINBOW-MBH)
Trial Parameters
Brief Summary
A nationwide, prospective, multicenter randomized controlled clinical trial to evaluate the therapeutic effects of the fiber tract-based artificial intelligence (AI) Robot Guiding System on the perioperative and long-term recovery of patients with moderate-volume basal ganglion hemorrhage.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 years at randomization 2. Hypertensive basal ganglia hemorrhage confirmed by CT/CTA 3. Hematoma volume 15-30 mL (excluding 30 mL) 4. Functional impairment (aphasia, hemiparesis with strength ≤3, or NIHSS ≥15) 5. CT shows stable hematoma (≥6h interval, change \<5 mL) 6. GCS ≥9 7. Surgery feasible within 72h after onset 8. Pre-ICH mRS ≤1 9. Informed consent obtained according to laws and ethics Exclusion Criteria: 1. Hematoma involving the thalamus, midbrain, or other areas 2. Radiologically diagnosed cerebrovascular abnormalities, as well as ischemic infarction converting to intracerebral hemorrhage, or recent (within 1 year) recurrence of intracerebral hemorrhage 3. Signs of impending brain herniation, such as midline shift \>1 cm or changes in the ipsilateral pupil; 4. Any irreversible coagulopathy disorders or known coagulation system disease; platelet count \<100,000; INR \>1.4; use of anticoagulants within 7 days prior to this hemorrhage; 5. Pregnant