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NCT Number: NCT06465719

A Trial for Minimally Invasive Neurosurgery With AI-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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location status: Recruiting

Location contact

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)
  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Other names: Surgery Group

Patients will be managed with guideline-based medications

Drug

Patients will be managed with guideline-based medications without surgery

Other names: Controlled Group

Primary outcomes

  1. Utility-weighted modified Rankin Scale (UW-mRS)

    Time frame: 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;

    • = 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.

Secondary outcomes

  1. Ordinal shift in modified Rankin Scale

    Time frame: 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.

  2. Excellent functional neurological outcome

    Time frame: 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.

  3. Independent functional neurological outcome

    Time frame: 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.

  4. Health Related Quality of Life

    Time frame: 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.

  5. Total length of hospital stay

    Time frame: 6 months

    Total length of hospital stay refers to the number of days from the date of hospital admission to the date of discharge.

  6. AD8 Dementia Screening

    Time frame: 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.

  7. Hematoma evacuation rate

    Time frame: 30 days after treatment

    Hematoma clearance rate at Day1 and Day30 after treatment

  8. Total medical expenses during hospitalization

    Time frame: 6 month

    Total medical expenses during hospitalization

Other outcomes

  1. Mortality

    Time frame: 6 months

    Mortality status equals to death which will be collected at all visits during the trial period

  2. Serious Adverse Events (SAEs)

    Time frame: 6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

  • China-Japan Friendship Hospital
  • Huashan Hospital
  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Registry information

Official study title

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

Acronym: RAINBOW-MBH

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 20, 2024
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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