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NCT Number: NCT03666897

Markers of Recovery in StrokE Study (MORSE)

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spectrum Health

Grand Rapids, Michigan, 49503, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DTI Images and Plasma Biomarkers

Other

Additional Images added from standard of care MRI, Bio-markers identified

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Corewell Health West

Other

Collaborators

  • Georgetown University

Registry information

Official study title

Markers of Recovery in StrokE Study

Acronym: MORSE

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Sep 12, 2018
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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