Correlation Between Clinical Neurological Biomarkers and Rehabilitation Outcome
PREVICTUS
Correlation Study Between Clinical, Neurophysiological, and Neuroradiological Biomarkers and Rehabilitation Outcomes to Predict Functional Recovery After Stroke and Personalize Treatment.
1 other identifier
observational
300
1 country
1
Brief Summary
Our study purpose is to evaluate the predictive power of various clinical, neurophysiological, and neuroimaging biomarkers-acquired and analyzed using advanced and integrated techniques-on motor functional recovery and disability post-stroke. The goal is to construct an integrated individual biomarker algorithm with a high predictive value for outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 15, 2020
CompletedFirst Submitted
Initial submission to the registry
January 28, 2025
CompletedFirst Posted
Study publicly available on registry
February 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
February 7, 2025
January 1, 2025
7.5 years
January 28, 2025
February 4, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
change in arm Fugl-Meyer score
assess the predictive power of biomarkers, individually or in combination, on the Fugl-Meyer Upper Limb Motor Scale (FM-UL) score at two months post-rehabilitation admission and at 4-6 months post-discharge
at T0 (from 14 to 30 days post-stroke), T1 (after 2 months of intensive rehabilitation treatment) and T2 (4-6 months after discharge).
Eligibility Criteria
The study will be conducted in the Neuromotor Rehabilitation Units (Modules A-B-C) of IRCCS San Raffaele Pisana, Rome, Italy
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS San Raffaele
Roma, Italy, 00163, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2025
First Posted
February 3, 2025
Study Start
June 15, 2020
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
June 30, 2028
Last Updated
February 7, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share