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

Recruiting now · Not applicable

Conditions studied: Basal Ganglia Hemorrhage

In brief

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.

Key facts

Study ID

NCT06465719

Run by

Second Affiliated Hospital, Zhejiang University, School of Medicine

People needed

330

Starts

2025-09-30

Expected to finish

2027-12-31

Last updated by the study team

2026-01-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years at randomization
• Hypertensive basal ganglia hemorrhage confirmed by CT/CTA
• Hematoma volume 15-30 mL (excluding 30 mL)
• Functional impairment (aphasia, hemiparesis with strength ≤3, or NIHSS ≥15)
• CT shows stable hematoma (≥6h interval, change <5 mL)
• GCS ≥9
• Surgery feasible within 72h after onset
• Pre-ICH mRS ≤1
• Informed consent obtained according to laws and ethics

You may not qualify if…

• Hematoma involving the thalamus, midbrain, or other areas
• Radiologically diagnosed cerebrovascular abnormalities, as well as ischemic infarction converting to intracerebral hemorrhage, or recent (within 1 year) recurrence of intracerebral hemorrhage
• Signs of impending brain herniation, such as midline shift >1 cm or changes in the ipsilateral pupil;
• 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;
• Pregnant or possibly pregnant
• Patients with severe concomitant diseases that may interfere with outcome assessment
• Poor compliance or follow-up difficulties

Where it is running

• the Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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