Markers of Recovery in StrokE Study (MORSE)

NCT ID: NCT03666897

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2022-04-01

Brief Summary

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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

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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.

Conditions

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Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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DTI Outcomes and Biomarkers

Imaging and Lab Collection

Group Type OTHER

DTI Images and Plasma Biomarkers

Intervention Type OTHER

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

Interventions

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DTI Images and Plasma Biomarkers

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Georgetown University

OTHER

Sponsor Role collaborator

Spectrum Health Hospitals

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Malgorzata Miller, MD

Role: PRINCIPAL_INVESTIGATOR

Spectrum Health Hospital

Locations

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Spectrum Health

Grand Rapids, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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2018-016

Identifier Type: -

Identifier Source: org_study_id

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