Intracerebral HemorrhageROSENCT04007757
Recovery and Outcomes From Stroke
An observational study of Intracerebral Hemorrhage, run by State University of New York at Buffalo at 8 sites in United States.
Trial summary
The investigators will perform follow-up on 500 cases of deep and lobar intracerebral hemorrhage to perform advanced neuroimaging before 45 days post stroke, and evaluations of motor and cognitive function at baseline, 3 months and 6 months to determine predictors of recovery, progressive cognitive or functional… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage
- How many people
- 500 participants
- Where
- 8 sitesUnited States
- Study dates
- 23 Aug 2017to 31 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Participants already enrolled in Genetic and Environmental Risk Factors for Hemorrhagic Stroke
Who may be able to join
- Age 18 years or greater, fulfillment of the criteria for Deep, Subcortical or Lobar Intracerebral Hemorrhage (ICH)
- No evidence of trauma, vascular malformation or aneurysm, or brain tumor as a cause of ICH.
- Ability of the patient or legal representative to provide informed consent
Who cannot join
- Brainstem or Cerebellar ICH
- Patients Severely Affected by the ICH, Early Mortality, Hospice, or Withdraw of Care NOT eligible for ROSE
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Maryland
Baltimore, Maryland, 21201
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Illinois Chicago
Chicago, Illinois, 60612
University of Cincinnati
Cincinnati, Ohio, 45267
Duke University
Durham, North Carolina, 27710
Houston Methodist
Houston, Texas, 77030
Baptist Health Louisville
Louisville, Kentucky, 40207
Columbia University
New York, New York, 10032
About this study
Official title: Recovery and Outcomes From Stroke (ROSE) Sub-study of Genetic and Environmental Risk Factors for Hemorrhagic Stroke
The investigators will perform follow-up on 500 cases of deep and lobar intracerebral hemorrhage to perform advanced neuroimaging before 45 days post stroke, and evaluations of motor and cognitive function at baseline, 3 months and 6 months to determine predictors of recovery, progressive cognitive or functional impairment.
Read the detailed description
Stroke is the third leading cause of death and the leading cause of adult disability in the United States. More adults are affected by stroke each year than Alzheimer's disease, multiple sclerosis, amyotrophic lateral sclerosis or Parkinson's disease. Hemorrhagic strokes represent the most severe subtypes of stroke. An estimated 40-50% of hemorrhagic stroke victims will die and more than 80% of survivors remain disabled after hemorrhagic stroke. Yet the vast majority of analyses on outcome after stroke have focused principally on gross measures of functional outcome.
Furthermore hemorrhagic stroke differs from ischemic stroke where a loss of blood causes the area affected to be readily visible on scanning. But with hemorrhagic stroke, not only the area that we can directly see, but nearby tracts that have been compressed or stretched by the mass of the hemorrhage can be injured.
The investigators propose to follow-up on 500 cases of deep and lobar ICH to perform serial evaluations of motor and cognitive function and advanced neuroimaging to determine predictors of recovery, progressive cognitive or functional impairment. Our proposal has the advantages of adding onto a prospective ICH study which will identify and recruit cases, ability to evaluate for the degree and impact of survival and severity biases, baseline neuroimaging which includes baseline MRI, biologic samples including genotyping for apolipoprotein E alleles and uniform phenotype definitions as well as expertise in recovery/outcome analyses, advanced neuroimaging processes and epidemiologic study. This proposal performs detailed cognitive, motor and functional assessments on cases of intracerebral hemorrhage and correlates with tractography imaging. The investigators hypothesize that unlike ischemic stroke, the mass effect of the hemorrhage itself may disrupt nearby tracts in some patients while preserving them in others and will serve as a better predictor of who may recover after ICH. This project will represent the largest number of ICH cases in which tractography imaging has been performed to date.
Specific Aim #1: Improve motor recovery prediction after supratentorial ICH by adding proportion of tract injury as measured by diffusion tensor imaging (DTI) independent of the ICH volume, location, age, gender and intraventricular hemorrhage (IVH).
Hypothesis #1a: Increasing severity of injury to corticospinal tracts in ICH patients will predict worse specific motor deficits assessed at 3-month and 6-month post-stroke.
Hypothesis #1b. Injury to cortical-cortical tracts including the superior longitudinal fasciculus, uncinate fasciculus, cingulum, and arcuate fasciculus, will predict greater impairment in corresponding cognitive domains including attention, memory, executive function, and language function assessed at 3 and 6-month post-stroke.
Specific Aim #2: Determine the association of periventricular tract injury in intraventricular hemorrhage complicating ICH with subsequent incontinence and gait ataxia.
Hypothesis #2: Patients with IVH will be associated with greater periventricular tract injury than patients without IVH and that this injury will be independently associated with long-term neurogenic incontinence and gait instability after controlling for severity of the ICH including location and volume, age and gender.
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Intracerebral Hemorrhage, Hemorrhagic Stroke, Intracerebral Hematoma
- Medical subject headings
- Cerebral Hemorrhage, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Participants who have had a hemorrhagic stroke and have been enrolled into the Genetic and Environmental Risk Factors for Hemorrhagic Stroke Study who live in the area of University of Cincinnati, Massachusetts General Hospital, University of Maryland, Duke University, Columbia University and University of Chicago Illinois, age 18 years or greater. Ability of participant or legal representative to provide informed consent. Racial/ethnic category of Caucasian, African American or Hispanic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change motor recovery prediction after supratentorial intracerebral hemorrhage(ICH)
This measure will determined by adding proportion of tract injury as measured by diffusion tensor imaging(DTI) methods. Measures are independent of the presenting Glasgow Coma Scale(GCS),ICH volume,location,age,sex and intraventricular hemorrhage (IVH).The primary outcome measure will be the global motor score from the motor assessment scale(MAS) testing which includes eight areas of assessment in eight areas of motor function.The MAS evaluates performance on functional tasks using a 7-point ordinal scale(0-6) in each of eight domains-moving from supine to side lying,supine to sitting over the edge of a bed, balanced sitting,moving from sitting to standing,walking,upper-arm function,hand movements(e.g., drawing a line),and advanced hand activities(e.g. combing the back of the head) rather than isolated movements. A score of 6 on each item, or an overall score of 48 indicates optimal motor behavior, and a lower score would indicate less than optimal motor behavior.
Measured: Ongoing/completed end of August 2020
Secondary outcomes (2)
Determine the correlation of periventricular tract injury in intraventricular hemorrhage(IVH) complicating intracerebral hemorrhage (ICH) with subsequent incontinence.
Determine the correlation of periventricular tract injury in IVH complicating ICH as measured by diffusion tensor imaging (DTI) with subsequent incontinence as measured by the Urogenital Distress Inventory (UDI-6),a 6 question measure of urinary continence that is highly reliable.The UDI-6 assessment scoring includes item responses that are assigned values of 0 for "not at all," 1 for "slightly," 2 for "moderately," and 3 for "greatly."The average score of items responded to is calculated,which ranges from 0 to 3,is multiplied by 33 1/3 to put scores on a scale of 0 to 100.The lower score would indicate a better outcome and a higher score would indicate a worse outcome.
Measured: Ongoing/completed end of August 2020
Determine the correlation of periventricular tract injury in intraventricular hemorrhage(IVH) with complicating intracerebral (ICH) with subsequent gait ataxia.
Determine the correlation of periventricular tract injury in IVH complicating intracerebral(ICH) as measured by diffusion tensor imaging(DTI) with subsequent gait ataxia as measured by motor assessment scale(MAS).The MAS includes eight areas of assessment in eight areas of motor function and evaluates performance on functional tasks using a 7 point ordinal scale(0-6) in each of the eight domains:moving from supine to side lying,supine to sitting over the edge of a bed,balanced sitting,moving from sitting to standing,walking, upper-arm function,hand movements(e.g., drawing a line), and advanced hand activities(e.g. combing the back of the head)rather than isolated movements.A score of 6 on each item,or an overall score of 48 indicates optimal motor behavior,and a lower score would indicate less than optimal motor behavior.
Measured: Ongoing/completed end of August 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start23 Aug 2017
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Massachusetts General Hospital, University of Maryland, Baltimore, Duke University, Durham, NC, Columbia University, University of Illinois Chicago, Baptist Health, Louisville, The Methodist Hospital Research Institute
- Responsible party
- Principal investigator, Daniel Woo, State University of New York at Buffalo
- Investigators
- Daniel Woo, MD, MS, Principal investigator, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007757
- Sponsor's protocol ID
- R01NS100417
- Other IDs
- R01NS100417
- Acronym
- ROSE
- Status last verified
- Jul 2025
- First submitted
- 11 Jun 2019
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery and Outcomes From Stroke (ROSE) Sub-study of Genetic and Environmental Risk Factors for Hemorrhagic Stroke
- ClinicalTrials.gov ID
- NCT04007757
- Acronym / sponsor ID
- ROSE / R01NS100417
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Intracerebral Hemorrhage, Hemorrhagic Stroke, Intracerebral Hematoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Massachusetts General Hospital, University of Maryland, Baltimore, Duke University, Durham, NC, Columbia University, University of Illinois Chicago, Baptist Health, Louisville, The Methodist Hospital Research Institute
- Study start
- 23 Aug 2017 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will perform follow-up on 500 cases of deep and lobar intracerebral hemorrhage to perform advanced neuroimaging before 45 days post stroke, and evaluations of motor and cognitive function at baseline, 3 months and 6 months to determine predictors of recovery, progressive cognitive or functional impairment.
Detailed description
Stroke is the third leading cause of death and the leading cause of adult disability in the United States. More adults are affected by stroke each year than Alzheimer's disease, multiple sclerosis, amyotrophic lateral sclerosis or Parkinson's disease. Hemorrhagic strokes represent the most severe subtypes of stroke. An estimated 40-50% of hemorrhagic stroke victims will die and more than 80% of survivors remain disabled after hemorrhagic stroke. Yet the vast majority of analyses on outcome after stroke have focused principally on gross measures of functional outcome.
Furthermore hemorrhagic stroke differs from ischemic stroke where a loss of blood causes the area affected to be readily visible on scanning. But with hemorrhagic stroke, not only the area that we can directly see, but nearby tracts that have been compressed or stretched by the mass of the hemorrhage can be injured.
The investigators propose to follow-up on 500 cases of deep and lobar ICH to perform serial evaluations of motor and cognitive function and advanced neuroimaging to determine predictors of recovery, progressive cognitive or functional impairment. Our proposal has the advantages of adding onto a prospective ICH study which will identify and recruit cases, ability to evaluate for the degree and impact of survival and severity biases, baseline neuroimaging which includes baseline MRI, biologic samples including genotyping for apolipoprotein E alleles and uniform phenotype definitions as well as expertise in recovery/outcome analyses, advanced neuroimaging processes and epidemiologic study. This proposal performs detailed cognitive, motor and functional assessments on cases of intracerebral hemorrhage and correlates with tractography imaging. The investigators hypothesize that unlike ischemic stroke, the mass effect of the hemorrhage itself may disrupt nearby tracts in some patients while preserving them in others and will serve as a better predictor of who may recover after ICH. This project will represent the largest number of ICH cases in which tractography imaging has been performed to date.
Specific Aim #1: Improve motor recovery prediction after supratentorial ICH by adding proportion of tract injury as measured by diffusion tensor imaging (DTI) independent of the ICH volume, location, age, gender and intraventricular hemorrhage (IVH).
Hypothesis #1a: Increasing severity of injury to corticospinal tracts in ICH patients will predict worse specific motor deficits assessed at 3-month and 6-month post-stroke.
Hypothesis #1b. Injury to cortical-cortical tracts including the superior longitudinal fasciculus, uncinate fasciculus, cingulum, and arcuate fasciculus, will predict greater impairment in corresponding cognitive domains including attention, memory, executive function, and language function assessed at 3 and 6-month post-stroke.
Specific Aim #2: Determine the association of periventricular tract injury in intraventricular hemorrhage complicating ICH with subsequent incontinence and gait ataxia.
Hypothesis #2: Patients with IVH will be associated with greater periventricular tract injury than patients without IVH and that this injury will be independently associated with long-term neurogenic incontinence and gait instability after controlling for severity of the ICH including location and volume, age and gender.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Participants who have had a hemorrhagic stroke and have been enrolled into the Genetic and Environmental Risk Factors for Hemorrhagic Stroke Study who live in the area of University of Cincinnati, Massachusetts General Hospital, University of Maryland, Duke University, Columbia University and University of Chicago Illinois, age 18 years or greater. Ability of participant or legal representative to provide informed consent. Racial/ethnic category of Caucasian, African American or Hispanic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants already enrolled in Genetic and Environmental Risk Factors for Hemorrhagic Stroke
Key inclusion criteria (3 listed)
- Age 18 years or greater, fulfillment of the criteria for Deep, Subcortical or Lobar Intracerebral Hemorrhage (ICH)
- No evidence of trauma, vascular malformation or aneurysm, or brain tumor as a cause of ICH.
- Ability of the patient or legal representative to provide informed consent
Key exclusion criteria (2 listed)
- Brainstem or Cerebellar ICH
- Patients Severely Affected by the ICH, Early Mortality, Hospice, or Withdraw of Care NOT eligible for ROSE
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change motor recovery prediction after supratentorial intracerebral hemorrhage(ICH)
Time frame: Ongoing/completed end of August 2020
This measure will determined by adding proportion of tract injury as measured by diffusion tensor imaging(DTI) methods. Measures are independent of the presenting Glasgow Coma Scale(GCS),ICH volume,location,age,sex and intraventricular hemorrhage (IVH).The primary outcome measure will be the global motor score from the motor assessment scale(MAS) testing which includes eight areas of assessment in eight areas of motor function.The MAS evaluates performance on functional tasks using a 7-point ordinal scale(0-6) in each of eight domains-moving from supine to side lying,supine to sitting over the edge of a bed, balanced sitting,moving from sitting to standing,walking,upper-arm function,hand movements(e.g., drawing a line),and advanced hand activities(e.g. combing the back of the head) rather than isolated movements. A score of 6 on each item, or an overall score of 48 indicates optimal motor behavior, and a lower score would indicate less than optimal motor behavior.
2 secondary outcomes
Determine the correlation of periventricular tract injury in intraventricular hemorrhage(IVH) complicating intracerebral hemorrhage (ICH) with subsequent incontinence.
Time frame: Ongoing/completed end of August 2020
Determine the correlation of periventricular tract injury in intraventricular hemorrhage(IVH) with complicating intracerebral (ICH) with subsequent gait ataxia.
Time frame: Ongoing/completed end of August 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Woo, MD, MS principal investigator
State University of New York at Buffalo
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracerebral Hemorrhage, run by State University of New York at Buffalo at 8 sites in United States.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change motor recovery prediction after supratentorial intracerebral hemorrhage(ICH) (time frame: Ongoing/completed end of August 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jul 2025.