Validation of biomarkers for recovery outcomes after stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to validate biomarkers that predict upper extremity motor outcomes in patients who have experienced an acute ischemic stroke or intracerebral hemorrhage. It will create a large-scale, multicenter dataset that includes clinical assessments, transcranial magnetic stimulation (TMS), and MRI measures during the acute stroke phase. The goal is to identify biologically distinct patient subgroups based on their motor cortex function and the extent of brain injury, which could inform personalized recovery therapies. The study will also validate the Predict Recovery Potential (PREP)-2 tool for predicting recovery outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18 years or older
2. Unilateral symptomatic stroke due to ischemia. (Note: Bilateral acute stroke is permitted if the stroke that is contralateral to the index stroke is asymptomatic).
3. 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).

   a. Please note that, if significant imbalance is observed in SAFE score or MEP+ rates, the enrollment threshold for SAFE score may be updated with a formal study memo.
4. 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)
5. Stated willingness to comply with all study procedures and availability for the duration of the study, including Day 90 visit which must occur in-person.
6. Fluent in study approved languages (i.e., English or Spanish)

Exclusion Criteria:

1. UE injury or conditions on paretic side that limited use prior to the stroke
2. Legally blind
3. Dense sensory loss on paretic side indicated by a score of 2 on NIHSS sensory item
4. Unable to abduct the shoulder or extend the fingers of the non-paretic UE on verbal command
5. Isolated cerebellar stroke
6. Symptomatic stroke in any location within 30 days prior to index stroke.
7. 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
8. Known or expected inability to maintain follow-up with study procedures through 90 days
9. Cognitive or communication impairment precluding informed consent by the participant.
10. Major medical, neurological, or psychiatric condition that would substantially affect functional status
11. Non-cerebrovascular diagnosis associated with unlikely survival at 90 days
12. Pregnancy
13. Contraindication to noncontrast MRI (certain metallic implants, metallic foreign bodies or severe claustrophobia)
14. Contraindication to TMS

    1. Implanted electronic cardiac devices (e.g., Automatic Implantable Cardioverter-Defibrillator \[AICD\] or pacemaker)
    2. Any 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)
    3. Ferromagnetic intracranial metallic implant
    4. Skull defect related to current stroke
    5. Seizure after onset of current stroke
    6. Seizure within the last 12 months while taking anti-epileptic medications
    7. Previous serious adverse reaction to TMS
15. Anticipated inability to perform study procedures within 168 hours of symptom onset

    1. Unable to perform behavioral assessments within 48-120 hours of symptom onset (or time last known well).
    2. Unable to receive TMS within 72-168 hours or get MRI within 48-168 hours of symptom onset (or time last known well).

Where it's running

• Birmingham VA Medical Center
  Birmingham, Alabama, United States Recruiting
• University of Alabama
  Birmingham, Alabama, United States Recruiting
• Banner University Medical Center
  Tucson, Arizona, United States Recruiting
• Keck Medical Center of USC
  Los Angeles, California, United States Recruiting
• Kaiser Permanente Redwood City Medical Center
  Redwood City, California, United States Recruiting
• San Francisco General Hospital
  San Francisco, California, United States Recruiting

Study contacts

• Principal investigator: Pooja Khatri, MD — Yale University
• Study coordinator: Pooja Khatri, MD
• Email: pooja.khatri@yale.edu
• Phone: 203-747-4730

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Effectiveness of a new neurorehabilitation technology for stroke recovery

  This study is testing a new rehabilitation technology that uses robots and virtual reality to see if it can help stroke patients recover better than regular therapy.

  Recruiting Neurotechnika · Samara, Samara Oblast · NCT06753006

• Stem cell therapy for chronic stroke recovery

  This study is testing whether using a patient's own stem cells can help people with long-term stroke recovery feel better and improve their daily functioning.

  Recruiting Phase 2 Hokkaido University Hospital · Sapporo, Hokkaido · NCT06752720

• Emergency Stroke Unit for treating acute strokes

  This study is testing a new Emergency Stroke Unit that uses a mobile MRI to see if it can help treat stroke patients faster and improve their recovery.

  Recruiting Chinese University of Hong Kong · Hong Kong · NCT06728592

• Monitoring brain-derived tau levels in acute ischemic stroke patients

  This study is testing how brain-derived tau levels change in stroke patients over 48 hours to see if it can help understand their condition and improve treatment decisions.

  Recruiting Ludwig-Maximilians - University of Munich · Munich, Bavaria · NCT06121336

• Comparing endovascular treatment and medical management for stroke patients with disabilities

  This study is testing whether a procedure called endovascular thrombectomy can help stroke patients with existing disabilities feel better compared to just using medication.

  Recruiting at 33 sites University of Cincinnati · Birmingham, Alabama and 34 other locations · NCT05911568

• Evaluating real-world effectiveness of endovascular thrombectomy for stroke in the Asia-Pacific region

  This study is testing how well a procedure called endovascular thrombectomy works for adults with a certain type of stroke in real-life situations across the Asia-Pacific region.

  Recruiting at 3 sites Chinese University of Hong Kong · Linyi, Shandong and 2 other locations · NCT05578300

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.