Clinical trial NCT04007757: Recovery and Outcomes From Stroke
Official title: Recovery and Outcomes From Stroke (ROSE) Sub-study of Genetic and Environmental Risk Factors for Hemorrhagic Stroke
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intracerebral Hemorrhage
Keywords: Intracerebral Hemorrhage
Hemorrhagic Stroke
Intracerebral Hematoma
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: Massachusetts General Hospital
name: University of Maryland, Baltimore
name: Duke University, Durham, NC
name: Columbia University
name: University of Illinois at Chicago
name: Baptist Health, Louisville
name: The Methodist Hospital Research Institute
First posted: 2019-07-05
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants already enrolled in Genetic and Environmental Risk Factors for Hemorrhagic Stroke

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Brainstem or Cerebellar ICH
* Patients Severely Affected by the ICH, Early Mortality, Hospice, or Withdraw of Care NOT eligible for ROSE

Primary outcomes:
measure: Change motor recovery prediction after supratentorial intracerebral hemorrhage(ICH)
timeFrame: Ongoing/completed end of August 2020
Secondary outcomes:
measure: Determine the correlation of periventricular tract injury in intraventricular hemorrhage(IVH) complicating intracerebral hemorrhage (ICH) with subsequent incontinence.
timeFrame: Ongoing/completed end of August 2020
measure: Determine the correlation of periventricular tract injury in intraventricular hemorrhage(IVH) with complicating intracerebral (ICH) with subsequent gait ataxia.
timeFrame: Ongoing/completed end of August 2020
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois Chicago
state: Illinois
city: Louisville
country: United States
facility: Baptist Health Louisville
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: New York
country: United States
facility: Columbia University
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Houston
country: United States
facility: Houston Methodist
state: Texas
Study officials:
affiliation: University of Cincinnati
name: Daniel Woo, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: