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

NCT05338697 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 657

Last updated 2025-10-15

No results posted yet for this study

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.

Conditions

  • Stroke
  • Stroke, Acute
  • Stroke, Ischemic

Interventions

DIAGNOSTIC_TEST

Transcranial Magnetic Stimulation (TMS)

No 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.

Sponsors & Collaborators

  • University of California, Los Angeles

    collaborator OTHER

  • University of Auckland, New Zealand

    collaborator OTHER

  • Medical University of South Carolina

    collaborator OTHER

  • University of Cincinnati

    lead OTHER

Principal Investigators

  • Pooja Khatri, MD · Yale University

  • Steve Cramer, MD · University of California, Los Angeles

  • Cathy Stinear, PhD · University of Auckland, New Zealand

  • Achala Vagal, MD · University of Cincinnati

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-18
Primary Completion
2027-01-31
Completion
2027-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05338697 on ClinicalTrials.gov