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

Markers of Recovery in StrokE Study

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: DTI Images and Plasma Biomarkers

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
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 90 days post stroke

Collaborators and Investigators

• Sponsor: Spectrum Health Hospitals
• Collaborators: Georgetown University
• Investigators: Principal Investigator: Malgorzata Miller, MD, Spectrum Health Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: August 7, 2018
• First Submitted That Met QC Criteria: September 7, 2018
• First Posted (Actual): September 12, 2018

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2018-016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No