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

A Multicenter, RAndomlzed, coNtrolled, umBrella Trial fOr Minimally Invasive Neurosurgery With Al-assisted Robotic Guidance for Moderate Basal Ganglia Hemorrhage (RAINBOW-MBH)

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 Overview

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

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 Type: Interventional
• Enrollment (Estimated): 330
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gao Chen; Phone Number: +86 0571-87784813; Email: d-chengao@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • The Second Affiliated Hospital of Zhejiang University School of Medicine
      • Contact: Gao Chen; Phone Number: +86 0571-87784813; Email: d-gaochen@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tract-based AI Robot Guiding System Group; Patients will be operated on minimally invasive puncture and aspiration using Tract-based AI Robot guidance System	Procedure: Minimally invasive basal ganglion hematoma evacuation with Tract-based AI Robot Guiding System; Basal ganglion hemorrhage patients will be operated on hematoma puncture and aspiration with Tract-based AI Robot Guiding System; Other Names: Surgery Group
Sham Comparator: Conservative Group; Patients will be managed with guideline-based medications without surgery	Drug: Patients will be managed with guideline-based medications; Patients will be managed with guideline-based medications without surgery; Other Names: Controlled Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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； = No significant disability. Able to carry out all usual activities, despite some symptoms；; = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities；; = Moderate disability. Requires some help, but able to walk unassisted；; = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted；; = Severe disability. Requires constant nursing care and attention, bedridden, incontinent；; = 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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	6 months
Health Related Quality of Life	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.	6 months
Total length of hospital stay	Total length of hospital stay refers to the number of days from the date of hospital admission to the date of discharge.	6 months
AD8 Dementia Screening	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.	6 months
Hematoma evacuation rate	Hematoma clearance rate at Day1 and Day30 after treatment	30 days after treatment
Total medical expenses during hospitalization	Total medical expenses during hospitalization	6 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Mortality status equals to death which will be collected at all visits during the trial period	6 months
Serious Adverse Events (SAEs)	The reporting and notification of SAEs follows ICH-GCP guidelines. According to the WHO International Drug Monitoring Centre (1994), an SAE is any adverse medical event that: Leading to death; Life-threatening; Requires hospitalization or prolongs existing hospitalization; Results in persistent or significant disability/incapacity; Congenital anomaly/birth defect; etc.	6 months

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Huashan Hospital; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; China-Japan Friendship Hospital
• Investigators: Principal Investigator: Gao Chen, Second Affiliated Hospital, School of Medicine, Zhejiang University

Publications and helpful links

Helpful Links

• A Multicenter, Randomized, Controlled, Umbrella Trial for Minimally Invasive Neurosurgery With Al-assisted Robotic Guidance for Hemorrhagic Stroke (RAINBOW-ICH)

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: June 13, 2024
• First Posted (Actual): June 20, 2024

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Hemorrhage; Basal Ganglia Diseases; Intracranial Hemorrhages; Basal Ganglia Cerebrovascular Disease; Cerebral Hemorrhage; Pathological Conditions, Signs and Symptoms; Basal Ganglia Hemorrhage; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Hemostatics; Coagulants; Calcium Channel Blockers; Nicardipine; Batroxobin
• Other Study ID Numbers: IRB-2024-0017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No