StrokePREVICTUSNCT06805929
Correlation Between Clinical Neurological Biomarkers and Rehabilitation Outcome
An observational study of Stroke, run by IRCCS San Raffaele Roma at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jun 2020to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will be conducted in the Neuromotor Rehabilitation Units (Modules A-B-C) of IRCCS San Raffaele Pisana, Rome, Italy
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Raffaele
Roma, Italy, 00163
Domenica Le Pera, Md, PhD, +390652252344, domenica.lepera@sanraffaele.it
About this study
Official title: Correlation Study Between Clinical, Neurophysiological, and Neuroradiological Biomarkers and Rehabilitation Outcomes to Predict Functional Recovery After Stroke and Personalize Treatment.
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.
Read the detailed description
Ability to predict post-stroke individual recovery still represents an important challenge to develop personalized and effective neurorehabilitation strategies. The aim of this study is to verify the predictive power of different clinical, neurophysiological and neuroimaging biomarkers in combination, acquired and analysed using advanced, integrated techniques, on functional motor recovery and post-stroke disability.
Patients with ischemic or hemorrhagic stroke and hemiparesis are subsequently enrolled and undergo multimodal assessment that includes measures spanning 4 assessment categories: demographic/medical history, clinical biomarkers, neurophysiological biomarkers (Motor Evoked Potentials, High-density EEG), neuroimaging biomarkers (infarct volume, corticospinal tract injury) at T0 (from 14 to 30 days post-stroke), T1 (after 2 months of intensive rehabilitation treatment) and T2 (4-6 months after discharge). Primary endpoint is change in arm Fugl-Meyer score. Secondary endpoints are changes in lower limb Fugl Meyer motor, Nine hole peg test, National Institute of Health Stroke Scale, mRS Rankin Scale, modified Barthel Index scores.
Multivariate analyses will indicate which biomarkers at baseline have the greatest value to predict significant changes in primary and secondary endpoints at T1 and T2.
A model incorporating measures of clinical, neurophysiological and neuroimaging biomarkers could best predict individual treatment-induced behavioral gains and therefore allow to plan a "tailor-made" rehabilitation project, select rehabilitation therapy, appropriate allocation of time and human resources and stratify clinical trial enrollees.
- Conditions
- Stroke
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at T0 (from 14 to 30 days post-stroke), T1 (after 2 months of intensive rehabilitation treatment) and T2 (4-6 months after discharge).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start15 Jun 2020
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805929
- Sponsor's protocol ID
- RP 20/15
- Acronym
- PREVICTUS
- Status last verified
- Nov 2026
- First submitted
- 28 Jan 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Study Between Clinical, Neurophysiological, and Neuroradiological Biomarkers and Rehabilitation Outcomes to Predict Functional Recovery After Stroke and Personalize Treatment.
- ClinicalTrials.gov ID
- NCT06805929
- Acronym / sponsor ID
- PREVICTUS / RP 20/15
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Ability to predict post-stroke individual recovery still represents an important challenge to develop personalized and effective neurorehabilitation strategies. The aim of this study is to verify the predictive power of different clinical, neurophysiological and neuroimaging biomarkers in combination, acquired and analysed using advanced, integrated techniques, on functional motor recovery and post-stroke disability.
Patients with ischemic or hemorrhagic stroke and hemiparesis are subsequently enrolled and undergo multimodal assessment that includes measures spanning 4 assessment categories: demographic/medical history, clinical biomarkers, neurophysiological biomarkers (Motor Evoked Potentials, High-density EEG), neuroimaging biomarkers (infarct volume, corticospinal tract injury) at T0 (from 14 to 30 days post-stroke), T1 (after 2 months of intensive rehabilitation treatment) and T2 (4-6 months after discharge). Primary endpoint is change in arm Fugl-Meyer score. Secondary endpoints are changes in lower limb Fugl Meyer motor, Nine hole peg test, National Institute of Health Stroke Scale, mRS Rankin Scale, modified Barthel Index scores.
Multivariate analyses will indicate which biomarkers at baseline have the greatest value to predict significant changes in primary and secondary endpoints at T1 and T2.
A model incorporating measures of clinical, neurophysiological and neuroimaging biomarkers could best predict individual treatment-induced behavioral gains and therefore allow to plan a "tailor-made" rehabilitation project, select rehabilitation therapy, appropriate allocation of time and human resources and stratify clinical trial enrollees.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted in the Neuromotor Rehabilitation Units (Modules A-B-C) of IRCCS San Raffaele Pisana, Rome, Italy
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change in arm Fugl-Meyer score
Time frame: at T0 (from 14 to 30 days post-stroke), T1 (after 2 months of intensive rehabilitation treatment) and T2 (4-6 months after discharge).
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by IRCCS San Raffaele Roma at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Domenica Le Pera, MD, PhD (+390652252344, domenica.lepera@sanraffaele.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in arm Fugl-Meyer score (time frame: at T0 (from 14 to 30 days post-stroke), T1 (after 2 months of intensive rehabilitation treatment) and T2 (4-6 months after discharge).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.