A Trial for Minimally Invasive Neurosurgery With AI-assisted Robotic Guidance for Moderate Basal … (NCT06465719) | Clinical Trial Compass
RecruitingNot Applicable
A Trial for Minimally Invasive Neurosurgery With AI-assisted Robotic Guidance for Moderate Basal Ganglia Hemorrhage (RAINBOW-MBH)
China330 participantsStarted 2025-09-30
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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)
✕. 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
✕
What they're measuring
1
Utility-weighted modified Rankin Scale (UW-mRS)
Timeframe: 6 months
Trial details
NCT IDNCT06465719
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University