Understanding motor recovery in stroke patients through early imaging

MECHANIST: Motor rECovery witH eArly imagiNg In STroke

This study looks at how brain imaging can help us understand movement problems in stroke patients and see if it can predict their recovery over time.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Northwestern University (Academic / other)
• Locations: 3 sites (Chicago, Illinois and 2 other locations)
• Trial ID: NCT04165616 on ClinicalTrials.gov

What this trial studies

This observational study aims to enhance knowledge of the neural mechanisms behind abnormal flexion synergy, a common movement impairment following a stroke. It will longitudinally assess motor tract morphology and motor function in stroke patients, utilizing neuroimaging and quantitative motor testing at multiple time points: within 96 hours, 2 weeks, 3 months, and 6 months post-stroke. The goal is to identify early neuroimaging-based predictors of flexion synergy development and its effects on reaching and hand recovery. By doing so, the study seeks to provide critical insights into the structural and functional changes in motor pathways over time.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 who have experienced a stroke within the middle cerebral artery distribution and exhibit isolated motor deficits.

Not a fit: Patients with significant aphasia, visual disturbances, or neglect may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved rehabilitation strategies for stroke patients, enhancing their recovery of motor function.

How similar studies have performed: Other studies have shown promise in using neuroimaging to predict recovery outcomes in stroke patients, suggesting this approach may be effective.

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

Where this trial is running

Chicago, Illinois and 2 other locations

• Department of Physical Therapy and Human Movement Sciences — Chicago, Illinois, United States (Not_yet_recruiting)
• Northwestern Memorial Hospital — Chicago, Illinois, United States (Recruiting)
• Shirley Ryan AbilityLab — Chicago, Illinois, United States (Recruiting)

Study contacts

• Principal investigator: Julius PA Dewald, PT, PhD — Northwestern University
• Study coordinator: Michael D Ellis, PT, DPT

Conditions Stroke