PERSonalized rObotic NeurorehAbilitation for Stroke Survivors

Recruiting

• Conditions: Stroke Acute

• Registration Number: NCT06312540
• Lead Sponsor: Azienda Ospedaliero, Universitaria Pisana

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.

Study Timeline

• Study Start: 2020-09-02
• Study First Submitted: 2024-02-19
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-08
• Last Update Submitted: 2024-03-08
• Study First Posted: 2024-03-15
• Last Update Posted: 2024-03-15
• Primary Completion: 2024-04-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Brain activity	36 months	Electroencephalography (EEG) power spectrum analysis
Functional evaluation	36 months	Fugl-Meyer Upper Limb (0-66)

Secondary Outcome Measures

Name	Time	Method
Spasticity assessment	36 months	Modified Ashworth Scale (0-4)
Clinical scale	36 months	Motricity Index (0-100); Wolf Motor Function Test

Trial Locations

Locations (1)

AOUPisana; 🇮🇹 Pisa, Pi, Italy