Markers of Recovery in StrokE Study (MORSE)

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: DTI Images and Plasma Biomarkers

• Registration Number: NCT03666897
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-08-07
• Study First Submitted QC: 2018-09-07
• Study First Posted: 2018-09-12
• Study Start: 2018-10-01
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DTI Outcomes and Biomarkers	DTI Images and Plasma Biomarkers	Imaging and Lab Collection

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Spectrum Health; 🇺🇸 Grand Rapids, Michigan, United States