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Recruiting NCT04165616

Motor rECovery witH eArly imagiNg In STroke

— Observational Stroke

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

MECHANIST: Motor rECovery witH eArly imagiNg In STroke

Overview

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.

Primary outcome measures

  • 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).]
  • 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).]
  • 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).]
  • 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).]
  • 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).]
  • 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).]
  • 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).]
  • 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).]
  • Predictive capacity of diffusor tensor imaging (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.]
  • 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).]
Secondary outcome measures (3)
  • 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).]
  • 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).]
  • 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).]

Eligibility criteria

Inclusion criteria

  • Stroke within the middle cerebral artery distribution based on brain MRI done within 48 hours of admission
  • 18 to 85 years old
  • Isolated motor deficits (hemiparesis) without significant aphasia, visual disturbances, or neglect based on the following scores on the NIH Stroke Scale: 1a (level of consciousness) = 0- Alert; keenly responsive. 1b (LOC questions) = 0- Asked month and age; Answers both correctly. 1c (LOC commands) = 0- Asked to open/close eyes, grasp/release hand; Performs both correctly. 2 (Best Gaze) = 0- Horizontal eye movements; Normal. 5 (Motor Arm) = 1, 2, 3, or 4- Arm placed at 90 (sitting) or 45 (supine), Drift, Some effort, No effort against gravity, or No movement. 7 (Limb Ataxia) = 0- Finger-nose-finger or heel-shin test; Absent. 8 (Sensory) = 0 or 1- Pin prick; Normal or Mild-to-moderate sensory loss. 9 (Best Language) = 0 or 1- Describe picture; No or Mild-to-moderate Aphasia. 11 (Extinction and Inattention) = 0 or 1- No abnormality or Inattention to one modality.

Exclusion criteria

  • Premorbid disability or sensorimotor impairment
  • Comorbidity medically contraindicating the administration of subsequent MRI scanning and motor assessments
  • Pain or hypersensitivity limiting motor assessment
  • Limb edema limiting motor assessment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 3 centers
  • Department of Physical Therapy and Human Movement Sciences — Chicago
  • Northwestern Memorial Hospital — Chicago
  • Shirley Ryan AbilityLab — Chicago

Publications

  • Karbasforoushan H, Cohen-Adad J, Dewald JPA. Brainstem and spinal cord MRI identifies altered sensorimotor pathways post-stroke. Nat Commun. 2019 Aug 6;10(1):3524. doi: 10.1038/s41467-019-11244-3. PMID 31388003
  • McPherson JG, Chen A, Ellis MD, Yao J, Heckman CJ, Dewald JPA. Progressive recruitment of contralesional cortico-reticulospinal pathways drives motor impairment post stroke. J Physiol. 2018 Apr 1;596(7):1211-1225. doi: 10.1113/JP274968. Epub 2018 Feb 19. PMID 29457651
  • Ellis MD, Carmona C, Drogos J, Dewald JPA. Progressive Abduction Loading Therapy with Horizontal-Plane Viscous Resistance Targeting Weakness and Flexion Synergy to Treat Upper Limb Function in Chronic Hemiparetic Stroke: A Randomized Clinical Trial. Front Neurol. 2018 Feb 19;9:71. doi: 10.3389/fneur.2018.00071. eCollection 2018. PMID 29515514

Identifiers

NCT: NCT04165616 · STU00210349 · R01NS105759

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗