PERSonalized rObotic NeurorehAbilitation for Stroke Survivors

Stroke Acute Clinical Trial

— PERSONA  

Official title:

Longitudinal Study of Biomarkers for Personalized Post-Stroke Rehabilitation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06312540
• Other study ID #: PERSONA
• Secondary ID: 15397/2018
• Status: Recruiting
• Start date: September 2, 2020
• Est. completion date: September 1, 2024

Study information

• Verified date: March 2024
• Source: Azienda Ospedaliero, Universitaria Pisana
• Contact: Carmelo Chisari, Medical
• Phone: 001 050996907
• Email: carmelo.chisari[@]unipi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Stroke Acute

Locations

Country	Name	City	State
Italy	AOUPisana	Pisa	Pi

Sponsors (3)

Lead Sponsor	Collaborator
Azienda Ospedaliero, Universitaria Pisana	Fondazione Don Carlo Gnocchi Onlus, Scuola Superiore Sant'Anna di Pisa

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain activity	Electroencephalography (EEG) power spectrum analysis	36 months
Primary	Functional evaluation	Fugl-Meyer Upper Limb (0-66)	36 months
Secondary	Clinical scale	Motricity Index (0-100); Wolf Motor Function Test	36 months
Secondary	Spasticity assessment	Modified Ashworth Scale (0-4)	36 months