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 range
18 Years
Sex
ALL
See this in plain English?
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)
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing AI-assisted robotic guidance for minimally invasive surgery on basal ganglia hemorrhages — how does that approach compare to the standard surgical or medical treatment my care team would normally recommend for my situation?
2Since this trial is listed as 'Phase NA,' what does that mean for how much is already known about the safety and effectiveness of this specific AI-guided robotic technique, and what risks should I be aware of that might differ from conventional surgery?
3The trial is measuring something called the Utility-Weighted Modified Rankin Scale — can you explain what that measures in plain terms and what kind of functional recovery outcome it's actually tracking for patients like me?
4Given that this involves brain surgery in the basal ganglia region, what are the specific surgical risks I should weigh before considering whether to discuss enrollment with you, compared to non-surgical management?
5What would my day-to-day experience look like if I were to participate — things like how long I'd be in the hospital, what follow-up visits are required, and whether the robotic procedure itself changes my recovery timeline compared to standard care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Utility-weighted modified Rankin Scale (UW-mRS)
Timeframe: 6 months
Trial details
NCT IDNCT06465719
SponsorSecond Affiliated Hospital, Zhejiang University, School of Medicine
. 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