PERSonalized rObotic NeurorehAbilitation for Stroke Survivors (PERSONA)

Longitudinal Study of Biomarkers for Personalized Post-Stroke Rehabilitation

The aim is to carry out a first clinical study, to expand existing knowledge about the neurophysiological mechanisms underlying post-stroke recovery. The information acquired during this phase will be used as building blocks to develop customized protocols. Understanding the mechanisms underlying stroke-induced motor deficits and motor recovery is mandatory to improve clinicians; ability to guide the repair of the affected neural structures. The motor system comprises a network of cortical and subcortical areas interacting via excitatory and inhibitory circuits, thereby governing motor behaviour. Stroke lesions cause neural dysfunction both at the lesion site and in remote brain regions. Abnormal interactions among cortical regions within the motor network contribute to the motor impairment after stroke. Longitudinal analysis of neural activity and connectivity can help to understand the pathophysiology mechanisms underlying functional impairment and recovery after stroke. Analysis of the data will try to extract biomarkers of plasticity and recovery that will be used to design customized therapeutic interventions.

Study Overview

• Status: Completed
• Conditions: Stroke Acute

Detailed Description

Consecutive stroke patients admitted to the Stroke Unit will be enrolled. Both ischaemic and hemorrhagic strokes above 18-years of age will be recruited. A dedicated encrypted database will be developed, and the following items will be collected: age, sex, aetiology of stroke, TOAST classification, Modified Rankin Scale before stroke and at the discharge from the Stroke Unit and after 3 months from the stroke (in survivors), NIHSS at the onset, at the discharge from the Stroke Unit, and after 3 months from the stroke (in survivors), neuroimaging studies at the onset (CT, AngioCT, MRI) and the follow up, acute treatment (for ischaemic strokes, fibrinolysis, primary or rescue thrombectomy, standard care), comorbidity (diabetes, hypertension, smoking habits, heart disease, atrial fibrillation, etc), biochemical and genetic biomarkers from blood and urine. The clinical and biochemical section of our database will include "yes or no" dichotomic items agreed by all groups in a preliminary consensus phase, specifically designed to define the clinical features known to be relevant in strokes.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Italy
  • Pi
    • Pisa, Pi, Italy, 56124
      • AOUPisana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Acute ischemic stroke survivors

Description

Inclusion Criteria:

• unilateral motor deficit (with or without other stroke- related symptoms or signs)
• radiological evidence of unilateral, supratentorial cerebral ischemic lesion (or lesions) in the same arterial territory
• stroke occurred in the last 4 days
• absent or slight disability before stroke estimated by a modified Rankin Scale 0-2

Exclusion Criteria:

• history of severe cognitive impairment
• psychiatric comorbidities
• end-stage organic diseases like cardiopulmonary, hepatic, renal failure, neoplasms, and whatever condition that could strongly reduce life expectation

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain activity	Electroencephalography (EEG) power spectrum analysis	36 months
Functional evaluation	Fugl-Meyer Upper Limb (0-66)	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical scale	Motricity Index (0-100) Wolf Motor Function Test	36 months
Spasticity assessment	Modified Ashworth Scale (0-4)	36 months

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero, Universitaria Pisana
• Collaborators: Fondazione Don Carlo Gnocchi Onlus; Scuola Superiore Sant'Anna di Pisa
• Investigators: Principal Investigator: Carmelo Chisari, Medical, Azienda Ospedaliero, Universitaria Pisana

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2020
• Primary Completion (Actual): September 1, 2024
• Study Completion (Actual): September 1, 2024

Study Registration Dates

• First Submitted: February 19, 2024
• First Submitted That Met QC Criteria: March 8, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): June 6, 2025
• Last Update Submitted That Met QC Criteria: June 4, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Upper extremities; Biomarkers; EEG; Machine Learning; Stroke recovery
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: PERSONA; 15397/2018 (Other Grant/Funding Number: Tuscany Region - Bando FAS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No