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Markers of Recovery in StrokE Study (MORSE) (MORSE)

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ClinicalTrials.gov Identifier: NCT03666897
Recruitment Status : Enrolling by invitation
First Posted : September 12, 2018
Last Update Posted : September 13, 2018
Sponsor:
Collaborator:
Georgetown University
Information provided by (Responsible Party):
Spectrum Health Hospitals

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
Stroke Other: DTI Images and Plasma Biomarkers Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Markers of Recovery in StrokE Study
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Establish plasma metabolite biomarkers that mirror neuronal repair and identify structural changes following ischemic strokes [ Time Frame: 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 :
  1. Change in Fugl-Meyer [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03666897


Locations
United States, Michigan
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

Responsible Party: Spectrum Health Hospitals
ClinicalTrials.gov Identifier: NCT03666897     History of Changes
Other Study ID Numbers: IRB # 2018-016
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases