PERSonalized rObotic NeurorehAbilitation for Stroke Survivors

NCT06312540 | Completed

• 2 other identifiers: PERSONA15397/2018
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke Acute

Keywords

Stroke recovery; Biomarkers; EEG; Machine Learning; Upper extremities

Outcome Measures

Primary Outcomes (2)

• Brain activity

  Electroencephalography (EEG) power spectrum analysis

  36 months

• Functional evaluation

  Fugl-Meyer Upper Limb (0-66)

  36 months

Secondary Outcomes (2)

• Clinical scale

  36 months

• Spasticity assessment

  36 months

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Acute ischemic stroke survivors

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliero, Universitaria Pisana: lead
• Fondazione Don Carlo Gnocchi Onlus: collaborator
• Scuola Superiore Sant'Anna di Pisa: collaborator

Study Sites (1)

AOUPisana

Pisa, Pi, 56124, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Carmelo Chisari, Medical

  Azienda Ospedaliero, Universitaria Pisana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Neurorehabilitation Unit

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 15, 2024
• Study Start: September 2, 2020
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)