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Clinical Trials in Italy / NCT07718321
Recruiting Not applicable

Feasibility and Acceptability of StimolIrpinia for Cognitive Rehabilitation After Severe Acquired Brain Injury

NCT07718321 · tracked via the Priya Life Science Italy tracker
Sponsor
Alfonso Magliacano
Phase
Not applicable
Started
2026-06-22
Last updated
2026-07-21

Condition(s) studied

Severe Acquired Brain InjuryCognitive ImpairmentCognitive RehabilitationNeurorehabilitation

Investigational drug(s) / intervention(s)

StimolIrpinia-supported cognitive rehabilitation activities

StimolIrpinia-supported cognitive rehabilitation activities: StimolIrpinia is a multimedia repository of autobiographical and territorially relevant stimuli from the Irpinia area, including images, videos, iconographic materials, cultural information, local landmarks, traditional foods, and links to virtual exploration tools. The repository is not a medical device and does not provide autonomous therapeutic, diagnostic, or decision-support functions. Patients will receive six 30-minute sessions over two weeks. During each session, the operator will select multimedia materials and exercises according to the patient's life experiences, familiarity with the Irpinia area, and cognitive profile. Activities may include memory exercises, language exercises, spatial orientation tasks, autobiographical memory stimulation, recognition tasks, and gnosic activities. All patients will continue their routine comprehensive rehabilitation program.

Study summary

This single-center pilot study evaluates the feasibility, acceptability, usability, and preliminary stimulus validation of StimolIrpinia, a multimedia repository of culturally and territorially relevant autobiographical stimuli designed to support cognitive rehabilitation activities in patients with severe acquired brain injury (sABI). The repository includes images, videos, maps, local cultural information, and printable materials related to the Irpinia area in Campania, Italy. Healthy adult volunteers will review the stimuli for their ability to evoke autobiographical memories, familiarity, emotional activation, and pleasantness. Hospitalized patients with sABI will complete six 30-minute StimolIrpinia-supported rehabilitation sessions over two weeks in addition to their routine comprehensive rehabilitation program. Rehabilitation professionals will receive standardized training and will use the repository to personalize cognitive rehabilitation exercises. Usability and acceptability will be evaluated from both patient and operator perspectives.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Patient-reported System Usability Scale score for StimolIrpinia — Day 15, after completion of the 2-week intervention
    Usability of StimolIrpinia from the patient perspective will be assessed using the System Usability Scale. The System Usability Scale total score ranges from 0 to 100, with higher scores indicating greater perceived usability.
  • Healthcare professional-reported System Usability Scale score for StimolIrpinia — After completion of each healthcare professional's assigned StimolIrpinia sessions, up to 12 months
    Usability of StimolIrpinia from the healthcare professional perspective will be assessed using the System Usability Scale. The System Usability Scale total score ranges from 0 to 100, with higher scores indicating greater perceived usability.

Trial sites (1)

FacilityCityRegionStatus
Polo Specialistico Riabilitativo Fondazione Don Gnocchi Sant'Angelo dei Lombardi AV Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07718321 on ClinicalTrials.gov ↗ ← All trials in Italy