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

Launched by UNIVERSITY OF CINCINNATI · Apr 13, 2022

Keywords

ClinConnect Summary

The VERIFY trial is studying how certain biological markers can help predict how well someone will recover from a stroke, particularly focusing on their ability to move their arms and hands. This research is important as it aims to provide valuable information for future clinical trials that seek to improve stroke recovery. The trial is open to adults aged 18 and older who have had a stroke affecting one side of their body and are experiencing difficulty with arm movement within a few days of the stroke. Participants will be required to provide consent and complete some tests, including brain scans and assessments of their movement abilities.

If you or a loved one is interested in participating, you should be aware that there are some criteria to meet. For example, candidates must be fluent in English or Spanish, and cannot have had any significant arm injuries before the stroke. Participants can expect to engage in various assessments to help researchers gather important data about stroke recovery. This study hopes to create a large database that will enhance our understanding of stroke outcomes and ultimately lead to better treatments for those affected by strokes.

Gender

ALL

Eligibility criteria

• 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.