StimolIrpinia: a multimedia memory-based tool to support cognitive rehab after severe brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center pilot study will assess feasibility, usability, acceptability, and preliminary stimulus validation of StimolIrpinia, a multimedia repository of locally relevant autobiographical stimuli. Rehabilitation professionals will receive standardized training to incorporate StimolIrpinia into six 30-minute cognitive rehabilitation sessions over two weeks as an adjunct to routine care. Healthy volunteers will rate the stimuli for autobiographical evoke-ness, familiarity, emotional activation, and pleasantness, informing stimulus selection. The materials are designed to be flexible tools within standard rehabilitation practices and are not medical software or devices. The study aims to determine whether the repository can be feasibly integrated into real-world neurorehabilitation for adults with severe acquired brain injury living in the Irpinia region.

Why it matters

Who can join: the full rules

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.

Where it's running

• Polo Specialistico Riabilitativo Fondazione Don Gnocchi
  Sant'Angelo dei Lombardi, Av, Italy Recruiting

Study contacts

• Study coordinator: Alfonso Magliacano
• Email: amagliacano@dongnocchi.it
• Phone: 393387389414

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.