Recruiting

StimolIrpiniaStimolIrpinia for Cognitive Rehabilitation in Severe Acquired Brain Injury

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Study Aim

This study aims to assess the usability of StimolIrpinia, a tool for cognitive rehabilitation in severe acquired brain injury, from both the patient and healthcare professional perspectives using the System Usability Scale.

What is being tested

StimolIrpinia-supported cognitive rehabilitation activities

Behavioral
Who is being recruted

Mental Disorders+8

+ Brain Diseases

+ Central Nervous System Diseases

From 18 to 75 Years
See all eligibility criteria
How is the trial designed

Services Research Study

Interventional
Study Start: June 2026
See protocol details

Summary

Principal SponsorAlfonso Magliacano
Study ContactAlfonso MagliacanoMore contacts
Last updated: July 21, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 22, 2026

Actual date on which the first participant was enrolled.

Patients with severe acquired brain injury often present impairments in attention, memory, language, executive functions, visuospatial abilities, perception, reasoning, and learning. Traditional cognitive rehabilitation commonly uses standardized paper-and-pencil exercises, but the generalization of gains from abstract tasks to everyday functioning can be limited. StimolIrpinia was developed to provide ecological, culturally familiar, and emotionally meaningful material that can be flexibly integrated by rehabilitation professionals into ordinary cognitive rehabilitation activities. StimolIrpinia is not medical software and is not a medical device under Regulation (EU) 2017/745. It is a structured repository of multimedia rehabilitation-support materials. It does not provide clinical indications, treatment protocols, decision support, automated scoring, or autonomous therapeutic functions. The materials are selected and used under the responsibility of the rehabilitation professional within routine clinical practice. The repository contains 118 multimedia maps representing towns in the Irpinia geographic area and six macro-areas: Partenio; Valle Ufita-Baronia; Serinese-Solofrana; Alta Irpinia; Vallo di Lauro-Baianese; and Terminio-Cervialto. Each map may include historical and contemporary photographs, links for virtual territorial exploration, information on local patron saints and traditional inhabitants' nicknames, and images or recipes of typical dishes. Printable cards and a practical guide support the operator in proposing personalized cognitive activities, including cognitive estimation, memory, spatial orientation, language, autobiographical memory, orientation, recognition, and gnosic exercises. The study has two main components. First, a stimulus-validation phase will involve healthy adults who have lived for a prolonged period in the territory represented by the repository. Second, a usability phase will involve hospitalized sABI patients and rehabilitation professionals. Patients will complete six StimolIrpinia-supported sessions over two weeks, while continuing their routine rehabilitation program. At the end of the sessions, patients and operators will complete usability and acceptability measures and will provide qualitative feedback.

Principal SponsorAlfonso Magliacano
Study ContactAlfonso MagliacanoMore contacts
Last updated: July 21, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Services Research Study

These studies look at how healthcare is delivered, managed, and organized. They aim to improve care quality, patient experience, and access to treatment.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersBrain DiseasesCentral Nervous System DiseasesCognition DisordersCraniocerebral TraumaNervous System DiseasesWounds and InjuriesNeurocognitive DisordersTrauma, Nervous SystemBrain InjuriesCognitive Dysfunction

Criteria

Patients With Severe Acquired Brain Injury - Inclusion Criteria * Age between 18 and 75 years. * Level of Cognitive Functioning (LCF) score \>= 5 at study entry. * Stable clinical diagnosis, assessed by at least four repeated LCF evaluations within a 1-week time window. * History of severe acquired brain injury of traumatic, anoxic, vascular, or mixed etiology, defined as Glasgow Coma Scale score \<= 8 for at least 24 hours after brain injury. * Pathological performance on at least one Oxford Cognitive Screening (OCS) subscale. * Having lived for a prolonged period in the Irpinia area, including Partenio, Valle Ufita-Baronia, Serinese-Solofrana, Alta Irpinia, Vallo di Lauro-Baianese, and/or Terminio-Cervialto. * Written informed consent signed by the patient or by the patient's legal representative. Patients With Severe Acquired Brain Injury - Exclusion Criteria • Severe medical conditions that may prevent participation in rehabilitation sessions, including severe language deficits incompatible with understanding instructions, severe cardiovascular instability, photosensitive or reflex epilepsy, and disabling visual or hearing deficits. Rehabilitation Professionals/Operators - Inclusion Criteria * Age \>= 18 years. * Proven experience in neuromotor and/or cognitive rehabilitation of patients with severe acquired brain injury. * Written informed consent to participate in the study. Rehabilitation Professionals/Operators - Exclusion Criteria • Participation in the development of the StimolIrpinia repository, resulting in prior familiarity with the repository.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Inpatients with severe acquired brain injury will receive six 30-minute sessions of cognitive rehabilitation activities supported by the StimolIrpinia multimedia repository, delivered three times per week for two weeks, in addition to routine comprehensive rehabilitation.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Polo Specialistico Riabilitativo Fondazione Don Gnocchi

Sant'Angelo dei Lombardi, ItalyOpen Polo Specialistico Riabilitativo Fondazione Don Gnocchi in Google Maps
Recruiting
One Study Center