Recovery and Outcomes From Stroke

NCT04007757 | Completed

• 1 other identifier: R01NS100417
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 8

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.

Conditions

Intracerebral Hemorrhage

Keywords

Intracerebral Hemorrhage; Hemorrhagic Stroke; Intracerebral Hematoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Determine the correlation of periventricular tract injury in intraventricular hemorrhage(IVH) complicating intracerebral hemorrhage (ICH) with subsequent incontinence.

  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.

  Ongoing/completed end of August 2020

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Massachusetts General Hospital: collaborator
• University of Maryland, Baltimore: collaborator
• Duke University, Durham, NC: collaborator
• Columbia University: collaborator
• University of Illinois at Chicago: collaborator
• Baptist Health, Louisville: collaborator
• The Methodist Hospital Research Institute: collaborator

Study Sites (8)

University of Illinois Chicago

Chicago, Illinois, 60612, United States

Location

Baptist Health Louisville

Louisville, Kentucky, 40207, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood, DNA, RNA and complete blood count (CBC)

MeSH Terms

Conditions

Cerebral Hemorrhage; Hemorrhagic Stroke

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stroke

Study Officials

• Daniel Woo, MD, MS

  State University of New York at Buffalo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.,Professor

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: July 5, 2019
• Study Start: August 23, 2017
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)