Markers of Recovery in StrokE Study (MORSE)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Our long-term goal is to improve and hasten recovery following a stroke with translational research, which would combine the use of neuroimaging and identify neural repair metabolites. The objective and sequential step in fulfilling our long-term goal, is to identify differential expression of select stroke plasma biomarkers of neural repair, and image CST integrity in patients with good and poor recovery following an ischemic stroke. Diffusion tension imaging (DTI), will be used to image the neural repair as it occurs, further enhancing our understanding of stroke recovery. There are currently no known plasma biomarkers of neural repair. Identification of such biomarkers would be extremely valuable for designing stroke recovery drugs and timing rehabilitation therapies.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: DTI Outcomes and Biomarkers Imaging and Lab Collection |
Other: DTI Images and Plasma Biomarkers
Additional Images added from standard of care MRI, Bio-markers identified
|
Outcome Measures
Primary Outcome Measures
- Establish plasma metabolite biomarkers that mirror neuronal repair and identify structural changes following ischemic strokes [2 years]
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
Secondary Outcome Measures
- Change in Fugl-Meyer [Baseline, 90 days post stroke]
The Fugl-Meyer will be used to assess motor function at the shoulder, elbow, wrist, fingers, hip, knee, and foot. The scale ranges from 0 to 66 points, measuring the impairment level of the upper extremity. Zero indicates a high level of impairment or minimum hand motor function, while 66 points indicates an increased motor function which is similar to normal upper extremity function.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Imaging confirmed ischemic stroke within 7 days of stroke onset
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Age > 18 years
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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)
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Pre-stroke modified Rankin Scale (mRS) < 3
Exclusion Criteria:
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Active malignancy (not thought to be cured or in remission)
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Anemia (HCT < 25)
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Sepsis
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Suspected bacterial endocarditis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Spectrum Health | Grand Rapids | Michigan | United States | 49503 |
Sponsors and Collaborators
- Spectrum Health Hospitals
- Georgetown University
Investigators
- Principal Investigator: Muhib Khan, MD, Spectrum Health Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB # 2018-016