120 Participants Needed

Motor rECovery witH eArly imagiNg In STroke

(MECHANIST Trial)

Recruiting at 2 trial locations
MD
BR
Overseen ByBradley R Holubar, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Northwestern University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Research Team

JP

Julius PA Dewald, PT, PhD

Principal Investigator

Northwestern University

Eligibility Criteria

Inclusion Criteria

Stroke within the middle cerebral artery distribution based on brain MRI done within 48 hours of admission
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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Initial Assessment

Neuroimaging and quantitative motor testing conducted within 96 hours post-stroke

1 week
1 visit (in-person)

Early Follow-up

Neuroimaging and quantitative motor testing conducted 2 weeks post-stroke

2 weeks
1 visit (in-person)

Mid-term Follow-up

Neuroimaging and quantitative motor testing conducted 3 months post-stroke

3 months
1 visit (in-person)

Long-term Follow-up

Neuroimaging and quantitative motor testing conducted 6 months post-stroke

6 months
1 visit (in-person)

Treatment Details

Interventions

  • Motor Recovery with Early Imaging in Stroke

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials
1,403
Recruited
655,000+

Shirley Ryan AbilityLab

Collaborator

Trials
212
Recruited
17,900+
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