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OpenTrials
Completed

NCT Number: NCT06312540

PERSonalized rObotic NeurorehAbilitation for Stroke Survivors

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

AOUPisana

Pisa, Pi, 56124, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Brain activity

    Time frame: 36 months

    Electroencephalography (EEG) power spectrum analysis

  2. Functional evaluation

    Time frame: 36 months

    Fugl-Meyer Upper Limb (0-66)

Secondary outcomes

  1. Clinical scale

    Time frame: 36 months

    Motricity Index (0-100)

    Wolf Motor Function Test

  2. Spasticity assessment

    Time frame: 36 months

    Modified Ashworth Scale (0-4)

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero, Universitaria Pisana

Other

Collaborators

  • Fondazione Don Carlo Gnocchi ETS
  • Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna

Registry information

Official study title

Longitudinal Study of Biomarkers for Personalized Post-Stroke Rehabilitation

Acronym: PERSONA

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Mar 15, 2024
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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