PERSonalized rObotic NeurorehAbilitation for Stroke Survivors (PERSONA)

March 8, 2024 updated by: Carmelo Chisari, Azienda Ospedaliero, Universitaria Pisana

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

Recruiting

Conditions

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 (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Pi
      • Pisa, Pi, Italy, 56124
        • Recruiting
        • AOUPisana
        • Contact:
        • Sub-Investigator:
          • Stefania Dalise, Medical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical scale
Time Frame: 36 months

Motricity Index (0-100)

Wolf Motor Function Test
36 months
Spasticity assessment
Time Frame: 36 months
Modified Ashworth Scale (0-4)
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2020

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

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)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PERSONA
  • 15397/2018 (Other Grant/Funding Number: Tuscany Region - Bando FAS)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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