Recovery and Outcomes From Stroke (ROSE)

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.

Study Overview

• Status: Recruiting
• Conditions: Intracerebral Hemorrhage

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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Lee A Gilkerson, RN,BSN; Phone Number: 513-558-6140; Email: Lee.gilkerson@uc.edu
• Study Contact Backup: Name: Tyler P Behymer, BS; Phone Number: 513-558-0122; Email: Tyler.behymer@uc.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • University of Illinois Chicago
      • Contact: Maureen Hillman; Phone Number: 312-355-3863; Email: hillmann@uic.edu
      • Principal Investigator: Fernando Testai, M.D.
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Recruiting
      • Baptist Health Louisville
      • Contact: Karin Cryan; Phone Number: 502-259-5564; Email: karin.cryan@BHSI.COM
      • Principal Investigator: Ranjit Bagga, M.D.
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland
      • Principal Investigator: Steven Kittner, M.D.
      • Contact: Tiffany Watson; Phone Number: 410-706-1902; Email: tiwatson@som.umaryland.edu
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Principal Investigator: Jonathan Rosand, M.D.
      • Contact: Christina Kourkoulis, BS; Phone Number: 617-726-5358; Email: ckourkoulis@partners.org
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University
      • Contact: Angela Velazquez; Phone Number: 212-305-6071; Email: aqv2113@cumc.columbia.edu
      • Principal Investigator: David Roh, M.D.
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University
      • Contact: Andreea Podgoreanu; Email: andrea.podgoreanu@duke.edu
      • Principal Investigator: Michael L James, M.D.
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • Recruiting
      • University of Cincinnati
      • Contact: Lee A Gilkerson, RN,BSN; Phone Number: 513-558-6140; Email: Lee.gilkerson@uc.edu
      • Contact: Tyler P Behymer, BS; Phone Number: 513-558-0122; Email: Tyler.behymer@uc.edu
      • Principal Investigator: Daniel Woo, M.D.,MS
  • Texas
    • Houston, Texas, United States, 77030
      • Not yet recruiting
      • Houston Methodist
      • Contact: Jennifer Meeks, MS; Email: jmeeks@houstonmethodist.org
      • Principal Investigator: Farhaan Vahidy, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Participants already enrolled in Genetic and Environmental Risk Factors for Hemorrhagic Stroke

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Ongoing/completed end of August 2020

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Ongoing/completed end of August 2020

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Collaborators: Massachusetts General Hospital; University of Maryland, Baltimore; Columbia University; National Institute of Neurological Disorders and Stroke (NINDS); University of Illinois at Chicago; The Methodist Hospital Research Institute; Baptist Health, Louisville; Duke University, Durham, NC
• Investigators: Principal Investigator: Daniel Woo, MD, MS, University of Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2017
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: June 11, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): December 7, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Intracerebral Hemorrhage; Hemorrhagic Stroke; Intracerebral Hematoma
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage; Hemorrhagic Stroke
• Other Study ID Numbers: R01NS100417 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No