Markers of Recovery in StrokE Study (MORSE) (MORSE)
Primary Purpose
Stroke
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DTI Images and Plasma Biomarkers
Sponsored by
About this trial
This is an interventional other trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Active malignancy (not thought to be cured or in remission)
- Anemia (HCT < 25)
- Sepsis
- Suspected bacterial endocarditis
Sites / Locations
- Spectrum Health
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
DTI Outcomes and Biomarkers
Arm Description
Imaging and Lab Collection
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change in Fugl-Meyer
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.
Full Information
NCT ID
NCT03666897
First Posted
August 7, 2018
Last Updated
November 22, 2022
Sponsor
Spectrum Health Hospitals
Collaborators
Georgetown University
1. Study Identification
Unique Protocol Identification Number
NCT03666897
Brief Title
Markers of Recovery in StrokE Study (MORSE)
Acronym
MORSE
Official Title
Markers of Recovery in StrokE Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spectrum Health Hospitals
Collaborators
Georgetown University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DTI Outcomes and Biomarkers
Arm Type
Other
Arm Description
Imaging and Lab Collection
Intervention Type
Other
Intervention Name(s)
DTI Images and Plasma Biomarkers
Intervention Description
Additional Images added from standard of care MRI, Bio-markers identified
Primary Outcome Measure Information:
Title
Establish plasma metabolite biomarkers that mirror neuronal repair and identify structural changes following ischemic strokes
Description
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Change in Fugl-Meyer
Description
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.
Time Frame
Baseline, 90 days post stroke
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Active malignancy (not thought to be cured or in remission)
Anemia (HCT < 25)
Sepsis
Suspected bacterial endocarditis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhib Khan, MD
Organizational Affiliation
Spectrum Health Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Markers of Recovery in StrokE Study (MORSE)
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