NCT04323501: PSR_e2020

Post-stroke Recovery (PSR_e2020)

Status unknown NA Last updated 23 May 2022

What this trial tests

NA trial testing Experimental treatment in Stroke in 134 participants. Status unknown.

Timeline

1 May 2021

Primary endpoint
30 June 2023

30 June 2024

Quick facts

Lead sponsor	Universita di Verona
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	134
Start date	1 May 2021
Primary completion	30 June 2023
Estimated completion	30 June 2024
Sites	1 location across Italy

Drugs / interventions tested

• Experimental treatment
• Control group — full drug profile →

Conditions studied

• Stroke — all drugs for Stroke →

Sponsor

Universita di Verona — full company profile →

Who can join

18 and older, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study presented is part of the departmental project entitled: BEHAVIORS AND WELLNESS: A MULTIDISCIPLINARY APPROACH TO PROMOTE THE QUALITY OF LIFE IN VULNERABILITY CONDITIONS - winner of the MIUR grant "Departments of Excellence", provided by Law 232 of 2016.

The departmental project has the general aim of understanding the interaction between behaviours, motivational and psycho-biological aspects in a situation of neurodegenerative disease and/or mental distress, from which derive six different types of patients that constitute the six lines of research into which the departmental project is divided. The project, as all lines of research, is organized into two essential phases:

* Phase I: the creation of basic models based on the in-depth knowledge of the molecular, structural and functional mechanisms (both physiological and cognitive) as well as on the psychological components (e.g. the ability to cope with the disease and the implementation of strategies functionals to the well-being) which are better indicative of an improvement in the health conditions of the six different patient populations studied;
* Phase II: clinical-applicative integration in which studies will be carried out on the motivations and consequent behaviours in everyday life contexts. Therefore, will be highlighted actions to take place in the healthcare, educational and organizational fields, aimed to promote the implementation of the practices most clearly associated with improving the health conditions highlighted by basic research.

The peculiarity of the studies, that make the departmental project, consists in the effort to encourage translational research, multidisciplinarity and the integration of knowledge, stimulating an innovative dialogue between the different scientific disciplinary sectors present in the department. The purpose is to make evidence-based the whole path related to behaviours and strategies that promote well-being, connecting biological, motivational or behavioural aspects each other, that make it possible to recover or not worsen the conditions of health. The idea is to encourage, where possible, the implementation, even outside or in continuity with the strictly hospital context, of practices aimed at promoting the well-being and quality of life in people in conditions of vulnerability.

Each of the six research lines (1. Young patients with multiple sclerosis; 2. People with chronic brain stroke outcomes; 3. Parkinson's disease patients with symptoms of both physical and mental fatigue; 4. Preschooler population presents "regulatory disturbances"; 5. Migrants seeking international protection; 6. Population in old age and at risk of frailty) is integrated into the purposes and outcome of the departmental project, however, each providing a specific and appropriate study protocol, it is independently submitted to the approval of the Ethics Committee.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Occupational therapy for cognitive impairment in stroke patients.
   Gibson E, Koh CL, Eames S, Bennett S, et al · · 2022 · cited 29× · PMID 35349186 · DOI 10.1002/14651858.cd006430.pub3
2. MicroRNA (miR)-124: A Promising Therapeutic Gateway for Oncology.
   Gourishetti K, Balaji Easwaran V, Mostakim Y, Ranganath Pai KS, et al · · 2023 · cited 9× · PMID 37508353 · DOI 10.3390/biology12070922
3. Rehabilitation and Biomarkers of Stroke Recovery: Study Protocol for a Randomized Controlled Trial.
   Picelli A, Filippetti M, Del Piccolo L, Schena F, et al · · 2020 · cited 4× · PMID 33519698 · DOI 10.3389/fneur.2020.618200
4. Clinical Trials of Non-Coding RNAs as Diagnostic and Therapeutic Biomarkers for Central Nervous System Injuries.
   Wang H, Wang Q, Xiao X, Luo X, et al · · 2023 · PMID 36443964 · DOI 10.2174/1570159x21666221128090025