Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06312540
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-02-19
Brief Title:
PERSonalized rObotic NeurorehAbilitation for Stroke Survivors
Sponsor:
Azienda Ospedaliero Universitaria Pisana
Organization:
Azienda Ospedaliero Universitaria Pisana
Study Overview
Official Title:
Longitudinal Study of Biomarkers for Personalized Post-Stroke Rehabilitation
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PERSONA
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 153972018 | OTHER_GRANT | Tuscany Region - Bando FAS | None |