Markers of Recovery in StrokE Study (MORSE)

Stroke Clinical Trial

— MORSE  

Official title:

Markers of Recovery in StrokE Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03666897
• Other study ID #: 2018-016
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: April 1, 2022

Study information

• Verified date: February 2024
• Source: Spectrum Health Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• DTI Images and Plasma Biomarkers
Additional Images added from standard of care MRI, Bio-markers identified

Locations

Country	Name	City	State
United States	Spectrum Health	Grand Rapids	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Spectrum Health Hospitals	Georgetown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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