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Validation of Early Prognostic Data for Recovery Outcome After Stroke for Future, Higher Yield Trials

About

Brief Summary

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.

Study Type
Observational

Eligibility

Gender
All
Healthy Volunteers
Yes
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • Age 18 years or older
  • 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.

Join this Trial

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Study Stats
Protocol No.
22-000401
Category
Neurology
Contact
Ileana Grunberg
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05338697
For detailed technical eligibility, visit ClinicalTrials.gov.