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Basal Ganglia HemorrhageRAINBOW-MBHNCT06465719

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

A study testing Minimally invasive basal ganglion hematoma evacuation with Tract-based AI Robot Guiding System and Patients will be managed with guideline-based medications in people with Basal Ganglia Hemorrhage, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Basal Ganglia Hemorrhage
What is being tested?
Minimally invasive basal ganglion hematoma evacuation with Tract-based AI Robot Guiding System and Patients will be managed with guideline-based medications
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
330 participants
Where
1 siteChina
Study dates
30 Sep 2025to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • Surgery feasible within 72h after onset
  • Pre-ICH mRS ≤1
  • Informed consent obtained according to laws and ethics

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Gao Chen contact

+86 0571-87784813

d-chengao@zju.edu.cn

China1 site, 1 recruiting

  • the Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

    Gao Chen, +86 0571-87784813, d-gaochen@zju.edu.cn

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Minimally invasive basal ganglion hematoma evacuation with Tract-based AI Robot Guiding System, Patients will be managed with guideline-based medications
Medical subject headings
Basal Ganglia Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Minimally invasive basal ganglion hematoma evacuation with Tract-based AI Robot Guiding SystemProcedure or surgery

    Also called Surgery Group

    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

    Also called Controlled Group

    Patients will be managed with guideline-based medications without surgery

Study groups in NCT06465719
Study groupRoleWhat they receive
Tract-based AI Robot Guiding System GroupExperimentalPatients will be operated on minimally invasive puncture and aspiration using Tract-based AI Robot guidance System
Receives: Procedure: Minimally invasive basal ganglion hematoma evacuation with Tract-based AI Robot Guiding System
Conservative GroupSham comparatorPatients will be managed with guideline-based medications without surgery
Receives: Drug: Patients will be managed with guideline-based medications

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (8)

  1. 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.

    Measured: 6 months

  2. 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.

    Measured: 6 months

  3. 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.

    Measured: 6 months

  4. 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.

    Measured: 6 months

  5. 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.

    Measured: 6 months

  6. 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.

    Measured: 6 months

  7. Hematoma evacuation rate

    Hematoma clearance rate at Day1 and Day30 after treatment

    Measured: 30 days after treatment

  8. Total medical expenses during hospitalization

    Total medical expenses during hospitalization

    Measured: 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2024
  2. Study start30 Sep 2025
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
330 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06465719
Sponsor's protocol ID
IRB-2024-0017
Acronym
RAINBOW-MBH
Status last verified
Aug 2025
First submitted
4 Jun 2024
Last updated
8 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Minimally invasive basal ganglion hematoma evacuation with Tract-based AI Robot Guiding System and Patients will be managed with guideline-based medications in people with Basal Ganglia Hemorrhage, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gao Chen (+86 0571-87784813, d-chengao@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Utility-weighted modified Rankin Scale (UW-mRS) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06465719.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.

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