Markers of Recovery in StrokE Study (MORSE)
MORSE
1 other identifier
interventional
21
1 country
1
Brief Summary
Our current biological understanding of stroke recovery in humans is extremely limited and this lack of knowledge is a major challenge in reducing stroke disabilities and deficits. Evidence of neural repair in humans can be gleaned indirectly through functional outcome measures, but we propose that metabolomics may also provide a minimally invasive window into human brain repair. This study will integrate clinical imaging and molecular biomarkers as a diagnostic tool in further understanding stroke recovery mechanisms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Oct 2018
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2018
CompletedFirst Posted
Study publicly available on registry
September 12, 2018
CompletedStudy Start
First participant enrolled
October 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedFebruary 28, 2024
February 1, 2024
3.5 years
August 7, 2018
February 26, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Establish plasma metabolite biomarkers that mirror neuronal repair and identify structural changes following ischemic strokes
Identify differential expression of select stroke plasma biomarkers of neural repair through metabolic testing and imaging CST integrity in patients with good and poor recovery following an ischemic stroke
2 years
Secondary Outcomes (1)
Change in Fugl-Meyer
Baseline, 90 days post stroke
Study Arms (1)
DTI Outcomes and Biomarkers
OTHERImaging and Lab Collection
Interventions
Additional Images added from standard of care MRI, Bio-markers identified
Eligibility Criteria
You may qualify if:
- Imaging confirmed ischemic stroke within 7 days of stroke onset
- Age \> 18 years
- NIHSS ≥ 1 on arm item OR NIHSS = 0 on arm item but \< 3/5 strength on MRC scale in distal joint (flex/ext elbow or grip/ext hand)
- Pre-stroke modified Rankin Scale (mRS) \< 3
You may not qualify if:
- Active malignancy (not thought to be cured or in remission)
- Anemia (HCT \< 25)
- Sepsis
- Suspected bacterial endocarditis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Corewell Health Westlead
- Georgetown Universitycollaborator
Study Sites (1)
Spectrum Health
Grand Rapids, Michigan, 49503, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Malgorzata Miller, MD
Spectrum Health Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2018
First Posted
September 12, 2018
Study Start
October 1, 2018
Primary Completion
April 1, 2022
Study Completion
April 1, 2022
Last Updated
February 28, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share