Evaluating biomarkers to predict recovery after stroke
Correlation Study Between Clinical, Neurophysiological, and Neuroradiological Biomarkers and Rehabilitation Outcomes to Predict Functional Recovery After Stroke and Personalize Treatment.
This study is testing if certain medical tests can help predict how well people with stroke will recover their movement and function over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS San Raffaele Roma Academic / other |
| Locations | 1 site (Roma, Italy) |
| Trial ID | NCT06805929 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the predictive power of various clinical, neurophysiological, and neuroimaging biomarkers on motor functional recovery and disability following a stroke. Patients with ischemic or hemorrhagic strokes and hemiparesis will undergo a comprehensive multimodal assessment at multiple time points post-stroke. The study will analyze data to construct an integrated biomarker algorithm that can effectively predict individual recovery outcomes, focusing on changes in motor function as measured by the Fugl-Meyer score and other relevant assessments.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years who have experienced their first stroke in the middle cerebral artery territory and have upper limb plegia or paresis.
Not a fit: Patients with a history of previous strokes, strokes outside the middle cerebral artery territory, or other neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized rehabilitation strategies that significantly improve recovery outcomes for stroke patients.
How similar studies have performed: Other studies have shown promise in using biomarkers for predicting recovery outcomes in stroke patients, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * First stroke in the middle cerebral artery territory. * Ischemic or hemorrhagic stroke (7-30 days post-acute event). * Upper limb plegia or paresis. * Both genders, aged \>18 years. * Ability to provide informed consent by the patient or caregiver/responsible relative. Exclusion Criteria: * Previous stroke. * Stroke in territories other than the middle cerebral artery. * Inability to provide informed consent. * Contraindications to TMS or MRI. * History of cancer in the past two years. * Presence of other neurological conditions interfering with biomarkers
Where this trial is running
Roma, Italy
- IRCCS San Raffaele — Roma, Italy, Italy (Recruiting)
Study contacts
- Study coordinator: Domenica Le Pera, MD, PhD
- Email: domenica.lepera@sanraffaele.it
- Phone: +390652252344
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.