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

Not Applicable

Not yet recruiting

• Conditions: Basal Ganglia Hemorrhage
• Interventions: Procedure: Minimally invasive basal ganglion hematoma evacuation with Tract-based AI Robot Guiding System; Drug: Patients will be managed with guideline-based medications

• Registration Number: NCT06465719
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-06-04
• Study First Submitted QC: 2024-06-13
• Study First Posted: 2024-06-20
• Status Verified: 2025-08
• Last Update Submitted: 2025-09-30
• Study Start: 2025-10-01
• Last Update Posted: 2025-10-06
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 330

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tract-based AI Robot Guiding System Group	Minimally invasive basal ganglion hematoma evacuation with Tract-based AI Robot Guiding System	Patients will be operated on minimally invasive puncture and aspiration using Tract-based AI Robot guidance System
Conservative Group	Patients will be managed with guideline-based medications	Patients will be managed with guideline-based medications without surgery

Primary Outcome Measures

Name	Time	Method
Utility-weighted modified Rankin Scale (UW-mRS)	6 months	The mRS is a 7-level ordinal scale used to evaluate functional outcomes after stroke. The categories are defined as follows: 0 = No symptoms； 1. = No significant disability. Able to carry out all usual activities, despite some symptoms； 2. = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities； 3. = Moderate disability. Requires some help, but able to walk unassisted； 4. = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted； 5. = Severe disability. Requires constant nursing care and attention, bedridden, incontinent； 6. = Dead； Utility-weighted modified Rankin Scale (UW-mRS), which applies utility values to each mRS category as shown below： mRS 0= UW-mRS 1；mRS 1= UW-mRS 0.91; mRS 2= UW-mRS 0.76; mRS 3= UW-mRS 0.65; mRS 4= UW-mRS 0.33; mRS 5= UW-mRS 0; mRS 6= UW-mRS 0.

Secondary Outcome Measures

Name	Time	Method
Ordinal shift in modified Rankin Scale	6 months	Ordinal shift analysis of the modified Rankin Scale (mRS), which measures the degree of disability or dependence in daily activities after stroke. The scale ranges from 0 (no symptoms) to 6 (death). This outcome assesses whether there is a shift toward better or worse functional status across the full ordinal distribution of mRS scores.
Excellent functional neurological outcome	6 months	Excellent functional neurological outcome means modified Rankin scale (mRS) scores 0-1. The minimum mRS is 0 (no symptoms) while the maximum mRS is 6 (death). The higher the mRS score is the worse outcome is.
Independent functional neurological outcome	6 months	Independent functional neurological outcome means modified Rankin scale (mRS) scores 0-2. The minimum mRS is 0 (no symptoms) while the maximum mRS is 6 (death). The higher the mRS score is the worse outcome is.
Health Related Quality of Life	6 months	Health Related Quality of Life based on EuroQol 5 Dimension 5 Level (EQ-5D-5L).The EQ-5D-5L is a generic instrument for describing and valuing health. It assesses five domains: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has five response categories corresponding to: no problems, slight, moderate, severe and extreme problems.
AD8 Dementia Screening	6 months	The AD8 (Eight-item Interview to Differentiate Aging and Dementia) is a brief screening tool designed to distinguish normal aging from possible dementia. The AD8 focuses on changes in memory, orientation, judgment, and daily activities. A greater number of "Yes" responses indicates higher likelihood of cognitive impairment or dementia, warranting further diagnostic evaluation.
Total length of hospital stay	6 months	Total length of hospital stay refers to the number of days from the date of hospital admission to the date of discharge.
Hematoma evacuation rate	30 days after treatment	Hematoma clearance rate at Day1 and Day30 after treatment
Total medical expenses during hospitalization	6 month	Total medical expenses during hospitalization

Trial Locations

Locations (1)

the Second Affiliated Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China