Validation of Early Prognostic Data for Recovery Outcome after Stroke for Future, Higher Yield Trials
Ann Marie Jones
Primary Investigator
Brief description of study
What is the purpose of this study?
Currently, 7 million US stroke survivors have significant disability, more than half with residual motor deficits. Motor function, particularly of the upper extremity (UE), is critical for regaining independence after stroke. VERIFY will validate biomarkers of upper extremity (UE) motor outcome in the acute ischemic stroke window for immediate use in clinical trials, and explore these biomarkers in acute intracerebral hemorrhage. VERIFY will create the first multicenter, large-scale, prospective dataset of clinical, transmagnetic stimulation (TMS), and MRI measures in the acute stroke time window.
The central objective is to validate the most biologically relevant and primed biomarkers of 90-day UE motor outcomes after ischemic stroke in the first large-scale, prospective, acute dataset of clinical, TMS, and MRI measures. The central hypothesis is that patients have different UE outcomes depending on CMS function measured with TMS, and on CST injury measured with MRI.
Detailed description of study
What will happen during the study?
The study will comprehensively measure UE outcomes 90 days post-stroke in three domains of motor performance -impairment, function, and use - identified by the World Health Organization International Classification of Functioning, Disability and Health.
By establishing biomarkers for use in the acute stroke period to identify patient subgroups with distinct 90-day outcomes, the study will improve the efficiency of stroke recovery trials and inform rehabilitation decision-making.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Ischemic stroke, Intracerebral hemorrhage
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Age: 18 years - 100 years
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Gender: All
Inclusion Criteria:
- Unilateral stroke due to ischemia or intracerebral hemorrhage
- Motor deficits in the acutely affected UE, defined as a Shoulder Abduction and Finger Extension (SAFE) score ≤ 8 out of 10 points (i.e., excluding full or nearly full motor strength in both shoulder abduction and finger extension) within 48 to 96 hours of stroke onset (or time last known well).
- Provision of signed and dated informed consent form within 48 to 96 hours of stroke onset (or time last known well).
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Fluent in English or Spanish
Exclusion Criteria:
- UE injury or conditions on paretic side that limited use prior to the stroke.
- Legally blind.
- Dense sensory loss indicated by a score of 2 on NIHSS sensory item
- Unable to abduct the shoulder or extend the fingers of the non-paretic arm/hand/wrist on verbal command
- Isolated cerebellar stroke
- Bilateral hemisphere acute strokes
- Co-enrollment in a trial of an intervention targeting the incident stroke (acute treatment or rehabilitation/recovery intervention) after baseline assessments for VERIFY are initiated
- Known or expected inability to maintain follow-up with study procedures through 90 days
- Cognitive or communication impairment precluding informed consent by the participant.
- Major medical, neurological, or psychiatric condition that would substantially affect functional status
- Non-cerebrovascular diagnosis associated with unlikely survival at 90 days
- Pregnancy
- Contraindication to noncontrast MRI (i.e., certain metallic implants, metallic foreign bodies or severe claustrophobia)
- Contraindication to TMS (i.e., cardiac pacemaker or other electronic devices in the body at or above the level of the seventh cervical vertebra, such as cochlear implant, cortical stimulator, deep brain stimulator, vagus nerve stimulator, cervical spine epidural stimulator, or ventriculoperitoneal shunt; Skull defect related to current stroke; Seizure after onset of current stroke; Seizure within the last 12 months while taking anti-epileptic medications; Previous serious adverse reaction to TMS)
- Unable to perform behavioral assessments within 48-120 hours of symptom onset
- Unable to receive TMS or get MRI within 72-168 hours of symptom onset
- Anticipated inability to perform study procedures within 168 hours of symptom onset.
