Validation of Early Prognostic Data for Recovery Outcome After Stroke for Future, Higher Yield Trials
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorYale University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
Unilateral symptomatic stroke due to ischemia. (Note: Bilateral acute stroke is permitted if the stroke that is contralateral to the index stroke is asymptomatic).
Motor deficits in the acutely affected UE, defined as a Shoulder Abduction and Finger Extension (SAFE) score ≤ 8 out of 10 points20,61 (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 24 to 96 hours of stroke onset, (or time last known well). Note: Participant is considered "enrolled" upon starting TMS (at least one stimulation is delivered) or starting study-specific MRI pulse sequence (at least one MRI beep occurs)
Disqualifiers
UE injury or conditions on paretic side that limited use prior to the stroke
Legally blind
Dense sensory loss on paretic side indicated by a score of 2 on NIHSS sensory item
Unable to abduct the shoulder or extend the fingers of the non-paretic UE on verbal command
Trial population
Patients with ischemic stroke consented within 24-96 hours of stroke onset in the acute hospitalization setting
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Transcranial Magnetic Stimulation (TMS)
Diagnostic testNo intervention used. This study is using TMS to obtain motor evoked potential (MEP), a prognostic biomarker. The TMS procedure is being conducted during the first week of hospitalization, which required registration under an IDE. Only TMS devices that have received 510(k) clearance from the FDA are used in this study, consisting of MEGA-TMS and MagStim 200-2.
Treatment groups
657 Participants
are divided into 1 treatment groupGroup A: Ischemic & Hemorrhagic stroke patients1 intervention
Trial outcomes
Primary outcomes
1
Upper Extremity-Fugl Meyer (UE-FM) for AIM 1
UE-FM score, as a continuous scale, adjusted for baseline score in analysis
Time frame
90 days post-stroke2
Action Research Arm Test (ARAT) for AIM 2
ARAT categorized as 'excellent', 'good', 'limited', or 'poor'
Time frame
90 days post-strokeOther outcomes
1
Motor Activity Log (MAL)
MAL categorized as 0 to 3 versus \>/=3 to 5.
Time frame
90 days post-stroke2
modified Rankin Score (mRS)
mRS level (0-6)
Time frame
90 days post-strokeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
University of California, Los Angeles
Collaborator
University of Auckland, New Zealand
Collaborator
Medical University of South Carolina
Collaborator
University of Cincinnati
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov