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

Second Affiliated Hospital, School of Medicine, Zhejiang University330 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

330

Conditions

Basal Ganglia Hemorrhage

Interventions

Minimally invasive basal ganglion hematoma evacuation with Tract-based AI Robot Guiding SystemPROCEDURE

Basal ganglion hemorrhage patients will be operated on hematoma puncture and aspiration with Tract-based AI Robot Guiding System

Patients will be managed with guideline-based medicationsDRUG

Patients will be managed with guideline-based medications without surgery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

the Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

Outcomes

Primary Outcomes

Utility-weighted modified Rankin Scale (UW-mRS)

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.

Time frame: 6 months

Secondary Outcomes

Ordinal shift in modified Rankin Scale

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.

Time frame: 6 months

Excellent functional neurological outcome

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.

Time frame: 6 months

Independent functional neurological outcome

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.

Time frame: 6 months

Central Contacts

Gao Chen

CONTACT

+86 0571-87784813 d-chengao@zju.edu.cn

Data from ClinicalTrials.gov

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