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

NCT06465719 | Recruiting DMC

• 1 other identifier: IRB-2024-0017
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

Basal Ganglia Hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (8)

• Ordinal shift in modified Rankin Scale

  6 months

• Excellent functional neurological outcome

  6 months

• Independent functional neurological outcome

  6 months

• Health Related Quality of Life

  6 months

• Total length of hospital stay

  6 months

Other Outcomes (2)

• Mortality

  6 months

• Serious Adverse Events (SAEs)

  6 months

Study Arms (2)

Tract-based AI Robot Guiding System Group

EXPERIMENTAL

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

Conservative Group

SHAM COMPARATOR

Patients will be managed with guideline-based medications without surgery

Drug: Patients will be managed with guideline-based medications

Interventions

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

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

Also known as: Surgery Group

Tract-based AI Robot Guiding System Group

Patients will be managed with guideline-based medications DRUG

Patients will be managed with guideline-based medications without surgery

Also known as: Controlled Group

Conservative Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• CT shows stable hematoma (≥6h interval, change \<5 mL)
• GCS ≥9
• Surgery feasible within 72h after onset
• Pre-ICH mRS ≤1
• Informed consent obtained according to laws and ethics

You may not qualify if:

• 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
• Poor compliance or follow-up difficulties

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Huashan Hospital: collaborator
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• China-Japan Friendship Hospital: collaborator

Study Sites (1)

the Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

Related Links

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

MeSH Terms

Conditions

Basal Ganglia Hemorrhage

Condition Hierarchy (Ancestors)

Basal Ganglia Cerebrovascular Disease; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebrovascular Disorders; Cerebral Hemorrhage; Intracranial Hemorrhages; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gao Chen

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gao Chen

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Patients will be randomly assigned to treatment or conservative group, so masking is only for outcome assessors
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 20, 2024
• Study Start: September 30, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 8, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)