Clinical trial NCT06312540: PERSonalized rObotic NeurorehAbilitation for Stroke Survivors
Official title: Longitudinal Study of Biomarkers for Personalized Post-Stroke Rehabilitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke Acute
Keywords: Stroke recovery
Biomarkers
EEG
Machine Learning
Upper extremities
Lead sponsor: Azienda Ospedaliero, Universitaria Pisana
Sponsor class: OTHER
Collaborators: name: Fondazione Don Carlo Gnocchi Onlus
name: Scuola Superiore Sant'Anna di Pisa
First posted: 2024-03-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Acute ischemic stroke survivors

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Brain activity
timeFrame: 36 months
measure: Functional evaluation
timeFrame: 36 months
Secondary outcomes:
measure: Clinical scale
timeFrame: 36 months
measure: Spasticity assessment
timeFrame: 36 months
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: AOUPisana
state: Pi
Study officials:
affiliation: Azienda Ospedaliero, Universitaria Pisana
name: Carmelo Chisari, Medical
role: PRINCIPAL_INVESTIGATOR
References: