MECHANIST: Motor rECovery witH eArly imagiNg In STroke

Sponsor
Northwestern University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04165616
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS) (NIH), Shirley Ryan AbilityLab (Other)
120
Enrollment
3
Locations
26.9
Anticipated Duration (Months)
40
Patients Per Site
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will contribute to the field of stroke rehabilitation research by expanding the investigator's understanding of the neural mechanisms responsible for the development and expression of abnormal flexion synergy, a primary movement impairment due to stroke. The study will longitudinally evaluate motor tract morphology and motor impairment/function in an attempt to develop early neuroimaging-based predictors of the development of flexion synergy and its impact on reaching and hand recovery (6 month). The study will utilize quantitative motor testing (kinematics and kinetics) to measure motor impairment and reaching and hand function. Both neuroimaging and quantitative motor testing will be conducted within 96 hours-, 2 weeks-, 3 months-, and 6 months-post stroke. The knowledge gained by this study will provide crucial structural and functional neuroimaging evidence that demonstrates the timeline of progressive ipsi- and contralesional motor pathway (including bulbospinal pathways) changes and the associated development of flexion synergy that grossly impacts reaching and hand function in individuals with moderate to severe stroke.

Condition or DiseaseIntervention/TreatmentPhase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    120 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    MECHANIST: Motor rECovery witH eArly imagiNg In STroke
    Anticipated Study Start Date :
    Feb 1, 2022
    Anticipated Primary Completion Date :
    Jan 1, 2024
    Anticipated Study Completion Date :
    May 1, 2024

    Arms and Interventions

    ArmIntervention/Treatment
    Individuals with stroke

    Outcome Measures

    Primary Outcome Measures

    1. Change in fractional anisotropy [Change in fractional anisotropy will be modeled over 4 time points (48-96 hours-, 2 weeks-, 3 months-, and 6 months post-stroke).]

      Fractional anisotropy is a quantitative measure of fiber density, axonal diameter, and myelination in the corticofugal, corticoreticulospinal, and corticorubrospinal tracts derived from the diffusion tensor imaging dataset.

    2. Change in complexity [Change in complexity will be modeled over 4 time points (48-96 hours-, 2 weeks-, 3 months-, and 6 months post-stroke).]

      Complexity (alpha) is an index of the non-Gaussian diffusion dynamics within the corticofugal, corticoreticulospinal, and corticorubrospinal tracts derived from the diffusion tensor imaging dataset.

    3. Change in mean diffusivity [Change in mean diffusivity will be modeled over 4 time points (48-96 hours-, 2 weeks-, 3 months-, and 6 months post-stroke).]

      Mean diffusivity is a measure of neural tract integrity quantifying the rotationally invariant magnitude of water diffusion within neural tissue defined by the 3-dimensional diffusion tensor.

    4. Change in radial diffusivity [Change in radial diffusivity will be modeled over 4 time points (48-96 hours-, 2 weeks-, 3 months-, and 6 months post-stroke).]

      Radial diffusivity is a measure of neural membrane integrity quantifying the average of the two small-axis values of water diffusion within neural tissue defined by the 3-dimensional diffusion tensor.

    5. Change in axial diffusivity [Change in axial diffusivity will be modeled over 4 time points (48-96 hours-, 2 weeks-, 3 months-, and 6 months post-stroke).]

      Axial diffusivity is a measure of neural tract direction quantifying the long-axis value of water diffusion within neural tissue defined by the 3-dimensional diffusion tensor.

    6. Change in maximum reaching distance [Change in maximum reaching distance will be modeled over 4 time points (48-96 hours-, 2 weeks-, 3 months-, and 6 months post-stroke).]

      Quantitative evaluation of reaching accounting for the expression of both flexion synergy and weakness by calculating distance from reaching kinematics data during ballistic outward reaches against various abduction loads.

    7. Change in maximum hand aperture [Change in maximum hand aperture will be modeled over 4 time points (48-96 hours-, 2 weeks-, 3 months-, and 6 months post-stroke).]

      Quantitative evaluation of hand opening accounting for the expression of both flexion synergy and weakness by calculating the area of a pentagon formed by the finger tips from hand kinematics data obtained at various abduction loads.

    8. Change in maximum grasp force [Change in maximum grasp force will be modeled over 4 time points (48-96 hours-, 2 weeks-, 3 months-, and 6 months post-stroke).]

      Quantitative evaluation of hand closing accounting for the expression of both flexion synergy and weakness by calculating the mean surface grasp force of the hand at various abduction loads.

    9. Predictive capacity of diffusor tensor imaging (DTI) for 6-month reaching and hand performance [Changes in structural morphology from 48 hours to 2-weeks post-stroke will be evaluated as early predictors for the 6-month reaching and hand performance outcomes including ROC curve analysis.]

      Changes in structural morphology measured acutely will be evaluated as early predictors for chronic reaching and hand performance. Receiver operating characteristic (ROC) curve analysis will be used to evaluate the discrimination potential of each acute imaging measure in predicting chronic moderate versus severe motor impairment for each of the reaching and hand performance measures.

    10. Relationship between DTI and quantitative motor testing [Relationships between metrics will be modeled over 4 time points (48-96 hours-, 2 weeks-, 3 months-, and 6 months post-stroke).]

      The relationship between each structural morphology metric and each quantitative motor testing metric will be evaluated.

    Secondary Outcome Measures

    1. Change in Fugl-Meyer Motor Assessment [Change in Fugl-Meyer Motor Assessment will be modeled over 4 time points (48-96 hours-, 2 weeks-, 3 months-, and 6 months post-stroke).]

      Qualitative and clinical assessment of general motor impairment of arm following stroke. The scale evaluates movement impairment of the arm through observation. The scale ranges from 0-66 points with 66 indicating the best score.

    2. Change in Action Research Arm Test [Change in Action Research Arm Test will be modeled over 4 time points (48-96 hours-, 2 weeks-, 3 months-, and 6 months post-stroke).]

      Qualitative and clinical assessment of activity limitation (function) of the arm following stroke. The scale focusses on reaching, grasping, and releasing objects of various sizes. The scale ranges from 0-57 with 57 indicating the best score.

    3. Change in Stroke Impact Scale [Change in Stroke Impact Scale will be modeled over 4 time points (48-96 hours-, 2 weeks-, 3 months-, and 6 months post-stroke).]

      Structured interview to assess domains of the ICF (International Classification of Functioning, Disability and Health) in individuals following stroke. The domains include self-reported physical problems, memory and thinking, control of emotions, communication, daily activities, home and community mobility, the affected hand, participation and life roles, and global recovery. Each domain score is transformed to a scale of 0-100 with 100 being the best score.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Unilateral first-time ischemic stroke within the middle cerebral artery distribution based on brain MRI done within 48 hours of admission

    2. 21 to 80 years old

    3. Isolated motor deficits (hemiparesis) without significant aphasia, visual disturbances, or neglect based on the following scores on the NIH Stroke Scale:

    4. NIH Stroke Scale: 1a (level of consciousness). = 0

    5. NIH Stroke Scale: 1b (LOC questions). = 0

    6. NIH Stroke Scale: 1c (LOC commands). = 0

    7. NIH Stroke Scale: 2 (Best Gaze). = 0

    8. NIH Stroke Scale: 5 (Arm Motor). = 1, 2, or 3

    9. NIH Stroke Scale: 7 (Limb Ataxia). = 0

    10. NIH Stroke Scale: 8 (Sensory). = 0 or 1

    11. NIH Stroke Scale: 9 (Best Language). = 0 or 1

    12. NIH Stroke Scale: 11 (Extinction and Inattention). = 0 or 1

    Exclusion Criteria:
    1. Premorbid disability or sensorimotor impairment

    2. Comorbidity medically contraindicating the administration of subsequent MRI scanning and motor assessments

    3. Pain or hypersensitivity limiting motor assessment

    4. Limb edema limiting motor assessment

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Department of Physical Therapy and Human Movement SciencesChicagoIllinoisUnited States60611
    2Northwestern Memorial HospitalChicagoIllinoisUnited States60611
    3Shirley Ryan AbilityLabChicagoIllinoisUnited States60611

    Sponsors and Collaborators

    • Northwestern University
    • National Institute of Neurological Disorders and Stroke (NINDS)
    • Shirley Ryan AbilityLab

    Investigators

    • Principal Investigator: Julius P.A. Dewald, PT, PhD, Northwestern University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Julius Dewald, Professor and Chair, Northwestern University
    ClinicalTrials.gov Identifier:
    NCT04165616
    Other Study ID Numbers:
    • STU00210349
    • R01NS105759
    First Posted:
    Nov 18, 2019
    Last Update Posted:
    Nov 17, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 17, 2021