NCT05089331

ROSE-Longitudinal Assessment With Neuroimaging

Recovery and Outcomes From Stroke-Longitudinal Assessment With Neuroimaging

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: State University of New York at Buffalo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators will perform follow-up on 250 of 500 cases recruited into the ROSE study of cases with deep and lobar intracerebral hemorrhage to perform advanced neuroimaging at 12-24 months post stroke, and evaluations of motor and cognitive function at baseline, 6 months after baseline, and 12 months after baseline to determine predictors of recovery, progressive cognitive or functional impairment. The investigators propose to leverage the recruitment, DNA, RNA-seq and baseline advanced neuroimaging cohort of ROSE to obtain long-term neuroimaging and identical assessments longitudinally to address critical questions regarding the progressive decline of patients 12 to 24 months post intracerebral hemorrhage (ICH) with long term cognitive follow-up to 36 months on average. This proposal would represent the largest, and longest advanced neuroimaging and RNA-sequencing evaluation after ICH to date.

Detailed description

The investigators propose to leverage the recruitment, DNA, RNA-seq and baseline advanced neuroimaging cohort of ROSE to obtain long-term neuroimaging and identical assessments longitudinally to address critical questions regarding the progressive decline of patients 12 to 24 months post ICH with long term cognitive follow-up to 36 months on average. This proposal would represent the largest, and longest advanced neuroimaging and RNA-sequencing evaluation after ICH to date. Specific Aim #1: Determine if progressive cognitive impairment correlates with an increase in established markers of cerebral small vessel disease(CSVD) and cerebral amyloid angiopathy(CAA) (white matter disease, siderosis and microbleeds). Hypothesis #1: Incidence of progressive cognitive impairment after ICH will be associated with an increase in total burden of small vessel disease (including white matter disease (WMD), microbleeds or siderosis, perivascular spaces, lacunar infarcts and atrophy). Specific Aim #2: Determine if inflammation as measured by RNA-sequencing markers of inflammation correlates with progressive cognitive impairment. Hypothesis #2: Interleukin-8 related inflammation will be associated with incidence of cognitive impairment. Specific Aim #3: In this exploratory aim, we seek to identify novel neuroimaging markers associated with progressive cognitive decline. Exploratory Hypothesis #3: Contralateral hemispheric diffusion tensor imaging (DTI) measures and cortical to cortical tract integrity will decline in association with progressive cognitive impairment.

Conditions

• Intracerebral Hemorrhage

Timeline

• Start date: 2020-09-30
• Primary completion: 2026-03-01
• Completion: 2026-06-01
• First posted: 2021-10-22
• Last updated: 2025-07-04

Locations

7 sites across 1 country: United States