Clinical trial NCT04165616: Motor rECovery witH eArly imagiNg In STroke
Official title: MECHANIST: Motor rECovery witH eArly imagiNg In STroke
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: Shirley Ryan AbilityLab
First posted: 2019-11-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from the in-patient stroke unit based upon the study inclusion criteria.

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.


Eligibility criteria: Inclusion Criteria:

1. Stroke within the middle cerebral artery distribution based on brain MRI done within 48 hours of admission
2. 18 to 85 years old
3. 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:

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

Primary outcomes:
measure: Change in fractional anisotropy
timeFrame: Change in fractional anisotropy will be modeled over 4 time points (48-96 hours-, 2 weeks-, 3 months-, and 6 months post-stroke).
measure: Change in complexity
timeFrame: Change in complexity will be modeled over 4 time points (48-96 hours-, 2 weeks-, 3 months-, and 6 months post-stroke).
measure: Change in mean diffusivity
timeFrame: Change in mean diffusivity will be modeled over 4 time points (48-96 hours-, 2 weeks-, 3 months-, and 6 months post-stroke).
measure: Change in radial diffusivity
timeFrame: Change in radial diffusivity will be modeled over 4 time points (48-96 hours-, 2 weeks-, 3 months-, and 6 months post-stroke).
measure: Change in axial diffusivity
timeFrame: Change in axial diffusivity will be modeled over 4 time points (48-96 hours-, 2 weeks-, 3 months-, and 6 months post-stroke).
measure: Change in maximum reaching distance
timeFrame: Change in maximum reaching distance will be modeled over 4 time points (48-96 hours-, 2 weeks-, 3 months-, and 6 months post-stroke).
measure: Change in maximum hand aperture
timeFrame: Change in maximum hand aperture will be modeled over 4 time points (48-96 hours-, 2 weeks-, 3 months-, and 6 months post-stroke).
measure: Change in maximum grasp force
timeFrame: Change in maximum grasp force will be modeled over 4 time points (48-96 hours-, 2 weeks-, 3 months-, and 6 months post-stroke).
measure: Predictive capacity of diffusor tensor imaging (DTI) for 6-month reaching and hand performance
timeFrame: 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.
measure: Relationship between DTI and quantitative motor testing
timeFrame: Relationships between metrics will be modeled over 4 time points (48-96 hours-, 2 weeks-, 3 months-, and 6 months post-stroke).
Secondary outcomes:
measure: Change in Fugl-Meyer Motor Assessment
timeFrame: 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).
measure: Change in Action Research Arm Test
timeFrame: 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).
measure: Change in Stroke Impact Scale
timeFrame: Change in Stroke Impact Scale will be modeled over 4 time points (48-96 hours-, 2 weeks-, 3 months-, and 6 months post-stroke).
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Department of Physical Therapy and Human Movement Sciences
state: Illinois
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
affiliation: Northwestern University
name: Julius PA Dewald, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Yamada K. The glossophyaryngeal nerve response to taste and thermal stimuli in the rat, rabbit and cat. Kumamoto Med J. 1965 Jun 30;18(2):106-8. No abstract available.