Recovery and Outcomes From Stroke — ROSE  

Intracerebral Hemorrhage Clinical Trial

Official title: Recovery and Outcomes From Stroke (ROSE) Sub-study of Genetic and Environmental Risk Factors for Hemorrhagic Stroke

Status Recruiting

Clinical 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 impairment.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Hemorrhagic Stroke
• Intracerebral Hemorrhage

• NCT number: NCT04007757
• Study type: Observational
• Source: University of Cincinnati
• Contact: Tyler P Behymer, BS
• Phone: 513-558-0122
• Email: Tyler.behymer@uc.edu
• Status: Recruiting
• Start date: August 23, 2017
• Completion date: October 2024