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Motor rECovery witH eArly imagiNg In STroke (MECHANIST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04165616
Recruitment Status : Not yet recruiting
First Posted : November 18, 2019
Last Update Posted : June 11, 2020
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Shirley Ryan AbilityLab
Information provided by (Responsible Party):
Julius Dewald, Northwestern University

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 disease
Stroke

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: MECHANIST: Motor rECovery witH eArly imagiNg In STroke
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : May 2024

Group/Cohort
Individuals with stroke



Primary Outcome Measures :
  1. Change in fractional anisotropy [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 DTI for 6-month reaching and hand performance [ Time Frame: 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. 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be recruited from the in-patient stroke unit based upon the study inclusion criteria.
Criteria

Inclusion Criteria:

  1. No premorbid disability or sensorimotor impairment
  2. Unilateral first-time ischemic stroke within the middle cerebral artery distribution based on brain MRI done within 48 hours of admission
  3. Lack of comorbidity medically contraindicating the administration of subsequent MRI scanning and motor assessments
  4. Lack of pain or hypersensitivity limiting motor assessment
  5. Lack of limb edema limiting motor assessment
  6. Isolated motor deficits (hemiparesis)
  7. NIH Stroke Scale: 1a (level of consciousness). = 0
  8. NIH Stroke Scale: 1b (LOC questions). = 0
  9. NIH Stroke Scale: 1c (LOC commands). = 0
  10. NIH Stroke Scale: 2 (Best Gaze). = 0
  11. NIH Stroke Scale: 5 (Arm Motor). = 1, 2, or 3
  12. NIH Stroke Scale: 7 (Limb Ataxia). = 0
  13. NIH Stroke Scale: 8 (Sensory). = 0 or 1
  14. NIH Stroke Scale: 9 (Best Language). = 0 or 1
  15. NIH Stroke Scale: 11 (Extinction and Inattention). = 0 or 1

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04165616


Contacts
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Contact: Michael D Ellis, PT, DPT 312-503-4435 m-ellis@northwestern.edu
Contact: Bradley R Holubar, MS 312-503-4434 b-holubar@northwestern.edu

Locations
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United States, Illinois
Department of Physical Therapy and Human Movement Sciences
Chicago, Illinois, United States, 60611
Contact: Michael D Ellis, PT, DPT    312-503-4435    m-ellis@northwestern.edu   
Contact: Carolina Carmona, PT, DPT, NCS    3125034633    ccarmona@northwestern.edu   
Sub-Investigator: Michael D Ellis, PT, DPT         
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Contact: Farzaneh A Sorond, MD, PhD    312-503-6113    farzaneh.sorond@nm.org   
Contact: Heidi R Roth, PT, DHS, NCS    312-503-6018    heidi.roth1@northwestern.edu   
Sub-Investigator: Farzaneh A Sorond, MD, PhD         
Shirley Ryan AbilityLab
Chicago, Illinois, United States, 60611
Contact: Richard L Harvey, MD    312-238-1975    rharvey@sralab.org   
Contact: Heidi R Roth, PT, DHS, NCS    312-503-6018    heidi.roth1@northwestern.edu   
Sub-Investigator: Richard L Harvey, MD         
Sponsors and Collaborators
Northwestern University
National Institute of Neurological Disorders and Stroke (NINDS)
Shirley Ryan AbilityLab
Investigators
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Principal Investigator: Julius P.A. Dewald, PT, PhD Northwestern University
Publications:
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Responsible Party: Julius Dewald, Professor and Chair, Northwestern University
ClinicalTrials.gov Identifier: NCT04165616    
Other Study ID Numbers: STU00210349
R01NS105759 ( U.S. NIH Grant/Contract )
First Posted: November 18, 2019    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Final research data will be shared openly and timely in accordance with NIH Data Sharing Policy (https://grants.nih.gov/grants/policy/data_sharing/). Data sharing will occur through the primary repositories of Northwestern University DigitalHub (https://digitalhub.northwestern.edu/) and Open Science Framework (https://osf.io/). Data will be exported from the internal RedCap study data base in spreadsheet format and will be deidentified and coded. Data will be available through speaking engagements and publications, presentations at scientific symposia and seminars. Data sharing in the above repositories will be phased in time with acceptance for publication of the primary outcome paper near the end of the fifth year and then with each subsequent publication. Publications will include DOIs for the data repositories.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases