Long-term assessment of cognitive and motor function after intracerebral hemorrhage
Recovery and Outcomes From Stroke-Longitudinal Assessment With Neuroimaging
This study is testing how brain and movement skills change over time in 250 patients who had a type of stroke called intracerebral hemorrhage to see what helps them recover or if they might get worse.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | State University of New York at Buffalo Academic / other |
| Locations | 7 sites (Chicago, Illinois and 6 other locations) |
| Trial ID | NCT05089331 on ClinicalTrials.gov |
What this trial studies
This observational study will follow 250 patients who experienced deep and lobar intracerebral hemorrhage to conduct advanced neuroimaging and evaluate motor and cognitive functions at multiple time points, including baseline, 6 months, and 12 months post-stroke. The aim is to identify predictors of recovery and the potential for progressive cognitive or functional impairment over a period of 12 to 24 months, with long-term follow-up extending to an average of 36 months. This study represents the largest and longest evaluation of neuroimaging and RNA-sequencing after intracerebral hemorrhage to date.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years or older who have experienced deep, subcortical, or lobar intracerebral hemorrhage without other complicating factors.
Not a fit: Patients with brainstem or cerebellar intracerebral hemorrhage, or those severely affected by the hemorrhage, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the long-term cognitive and functional outcomes for patients after intracerebral hemorrhage, potentially guiding future therapeutic strategies.
How similar studies have performed: While this study builds on existing knowledge, it represents a novel and extensive approach to understanding long-term outcomes after intracerebral hemorrhage, with no prior studies of this scale in neuroimaging and RNA-sequencing.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or greater, fulfillment of the criteria for Deep, Subcortical or Lobar Intracerebral Hemorrhage * 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 ROS
Where this trial is running
Chicago, Illinois and 6 other locations
- University of Illinois Chicago — Chicago, Illinois, United States (Recruiting)
- Baptist Health Louisville — Louisville, Kentucky, United States (Recruiting)
- University of Maryland — Baltimore, Maryland, United States (Recruiting)
- Columbia University — New York, New York, United States (Recruiting)
- Duke University — Durham, North Carolina, United States (Recruiting)
- University of Cincinnati — Cincinnati, Ohio, United States (Recruiting)
- Houston Methodist — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Daniel Woo, MD, MS — State University of New York at Buffalo
- Study coordinator: Lee A Gilkerson, RN, BSN
- Email: Lee.gillkerson@uc.edu
- Phone: 5139191822
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.