Actively Recruiting
A Trial for Minimally Invasive Neurosurgery With AI-assisted Robotic Guidance for Moderate Basal Ganglia Hemorrhage (RAINBOW-MBH)
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-01-08
330
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor
H
Huashan Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Trial for Minimally Invasive Neurosurgery With AI-assisted Robotic Guidance for Moderate Basal Ganglia Hemorrhage (RAINBOW-MBH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at randomization
- Hypertensive basal ganglia hemorrhage confirmed by CT/CTA
- Hematoma volume between 15 and 30 mL (excluding 30 mL)
- Functional impairment including aphasia, hemiparesis with strength 3 or less, or NIHSS score 15 or higher
- Stable hematoma on CT scan with at least 6 hours interval and less than 5 mL change
- Glasgow Coma Scale score of 9 or higher
- Surgery can be performed within 72 hours after onset
- Modified Rankin Scale score of 1 or less before intracerebral hemorrhage
- Informed consent obtained according to laws and ethics
You will not qualify if you...
- Hematoma involving the thalamus, midbrain, or other areas
- Cerebrovascular abnormalities or ischemic infarction converting to intracerebral hemorrhage
- Recent recurrence of intracerebral hemorrhage within 1 year
- Signs of impending brain herniation such as midline shift over 1 cm or pupil changes
- Irreversible blood clotting disorders or known coagulation diseases
- Platelet count below 100,000 or INR above 1.4
- Use of anticoagulants within 7 days prior to hemorrhage
- Pregnant or possibly pregnant
- Severe other diseases that may affect outcome assessment
- Poor compliance or difficulty with follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
the Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
G
Gao Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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