A Trial for Minimally Invasive Neurosurgery With AI-assisted Robotic Guidance for Moderate Basal Ganglia Hemorrhage (RAINBOW-MBH)

A Multicenter, RAndomlzed, coNtrolled, umBrella Trial fOr Minimally Invasive Neurosurgery With Al-assisted Robotic Guidance for Moderate Basal Ganglia Hemorrhage (RAINBOW-MBH)

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.

Basal ganglion hemorrhage is one of the most common subtypes of cerebral hemorrhage, characterized by high morbidity, mortality, and disability rates. Minimally invasive surgery for cerebral hemorrhage, particularly utilizing a fiber tract-based AI Robot Guiding System, has shown potential advantages for patient prognosis. However, there is currently no standardized practice or robust evidence confirming the effectiveness and safety of this technology for small-volume basal ganglion hemorrhage. Therefore, we are conducting 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.

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 or possibly pregnant
6. Patients with severe concomitant diseases that may interfere with outcome assessment
7. Poor compliance or follow-up difficulties