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Severe Acquired Brain InjuryStimolIrpiniaNCT07718321

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

A study testing StimolIrpinia-supported cognitive rehabilitation activities in people with Severe Acquired Brain Injury and Cognitive Impairment, run by Alfonso Magliacano at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
What is being tested?
StimolIrpinia-supported cognitive rehabilitation activities
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteItaly
Study dates
22 Jun 2026to 22 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Alfonso Magliacano contact

393387389414

amagliacano@dongnocchi.it

Italy1 site, 1 recruiting

  • Polo Specialistico Riabilitativo Fondazione Don Gnocchi

    Sant'Angelo dei Lombardi, AV, 83054

    Alfonso Magliacano, 3387389414, amagliacano@dongnocchi.it

    amagliacano@dongnocchi.it

    Recruiting

Other trials in Italy

About this study

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.

Read the detailed description

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.

Being tested
StimolIrpinia-supported cognitive rehabilitation activities
Keywords
severe acquired brain injury, cognitive rehabilitation, ecological rehabiliation, autobiographical stimuli, multimedia repository, acceptability, usability, feasibility, irpinia
Medical subject headings
Brain Injuries, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • StimolIrpinia-supported cognitive rehabilitation activitiesBehavioural

    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 groups in NCT07718321
Study groupRoleWhat they receive
Patients receiving StimolIrpinia-supported cognitive rehabilitationExperimentalInpatients 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.
Receives: Behavioral: StimolIrpinia-supported cognitive rehabilitation activities

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient-reported System Usability Scale score for StimolIrpinia

    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.

    Measured: Day 15, after completion of the 2-week intervention

  2. Healthcare professional-reported System Usability Scale score for StimolIrpinia

    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.

    Measured: After completion of each healthcare professional's assigned StimolIrpinia sessions, up to 12 months

Secondary outcomes (6)

  1. Patient-reported Acceptability of Intervention Measure score for StimolIrpinia

    Acceptability of StimolIrpinia from the patient perspective will be assessed using the Acceptability of Intervention Measure. The measure includes 4 items rated on a 5-point Likert scale. The mean score ranges from 1 to 5, with higher scores indicating greater perceived acceptability.

    Measured: Day 15, after completion of the 2-week intervention

  2. Patient-reported Intervention Appropriateness Measure score for StimolIrpinia

    Perceived appropriateness of StimolIrpinia from the patient perspective will be assessed using the Intervention Appropriateness Measure. The measure includes 4 items rated on a 5-point Likert scale. The mean score ranges from 1 to 5, with higher scores indicating greater perceived appropriateness.

    Measured: Day 15, after completion of the 2-week intervention

  3. Patient-reported Feasibility of Intervention Measure score for StimolIrpinia

    Perceived feasibility of StimolIrpinia from the patient perspective will be assessed using the Feasibility of Intervention Measure. The measure includes 4 items rated on a 5-point Likert scale. The mean score ranges from 1 to 5, with higher scores indicating greater perceived feasibility.

    Measured: Day 15, after completion of the 2-week intervention

  4. Healthcare professional-reported Acceptability of Intervention Measure score for StimolIrpinia

    Acceptability of StimolIrpinia from the healthcare professional perspective will be assessed using the Acceptability of Intervention Measure. The measure includes 4 items rated on a 5-point Likert scale. The mean score ranges from 1 to 5, with higher scores indicating greater perceived acceptability.

    Measured: After completion of each healthcare professional's assigned StimolIrpinia sessions, up to 12 months

  5. Healthcare professional-reported Intervention Appropriateness Measure score for StimolIrpinia

    Perceived appropriateness of StimolIrpinia from the healthcare professional perspective will be assessed using the Intervention Appropriateness Measure. The measure includes 4 items rated on a 5-point Likert scale. The mean score ranges from 1 to 5, with higher scores indicating greater perceived appropriateness.

    Measured: After completion of each healthcare professional's assigned StimolIrpinia sessions, up to 12 months

  6. Healthcare professional-reported Feasibility of Intervention Measure score for StimolIrpinia

    Perceived feasibility of StimolIrpinia from the healthcare professional perspective will be assessed using the Feasibility of Intervention Measure. The measure includes 4 items rated on a 5-point Likert scale. The mean score ranges from 1 to 5, with higher scores indicating greater perceived feasibility.

    Measured: After completion of each healthcare professional's assigned StimolIrpinia sessions, up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2026
  2. Study start22 Jun 2026
  3. Primary completion22 Aug 2027 (estimated)
  4. Study completion22 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07718321
Sponsor's protocol ID
StimolIrpinia
Acronym
StimolIrpinia
Status last verified
Jul 2026
First submitted
13 Jul 2026
Last updated
21 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • - De Luca, R., Maggio, M. G., Naro, A., Portaro, S., Cannavò, A., & Calabrò, R. S. (2020). Can patients with severe traumatic brain injury be trained with cognitive telerehabilitation? An inpatient feasibility and usability study. Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia, 79, 246-250. https://doi.org/10.1016/j.jocn.2020.07.063 - Faulkner L. Beyond the five-user assumption: Benefits of increased sample sizes in usability testing. Behav Res Methods Instrum Comput. 2003;35(3):379-383. doi:10.3758/BF03195514 - Hwang W, Salvendy G. Number of people required for usability evaluation: The 10 ± 2 rule. Commun ACM. 2010;53(5):130-133. doi:10.1145/1735223.1735255 - Kunselman AR. Pilot studies and feasibility studies in clinical research. J Biopharm Stat. 2024;34(1):1-12. - Magliacano, A., Fiorentino, M. R., Scarano, G., Colella, M., Fasano, C., Spinola, M., Monda, A., Estraneo, A., & VR-sABI study group (2025). Non-immersive virtual reality for cognitive rehabilitation of individuals with severe acquired brain injury (VR-sABI): study protocol for a multicentric randomized controlled trial. Trials, 26(1), 392. https://doi.org/10.1186/s13063-025-09128-7 - Ponsford J, Sloan S, Snow P. Traumatic brain injury: Rehabilitation for everyday adaptive living. 2nd ed. New York: Psychology Press; 2013. - Wilson BA. Memory rehabilitation: Integrating theory and practice. New York: Guilford Press; 2009. - Woods B, Spector AE, Jones CA, Orrell M, Davies SP. Reminiscence therapy for dementia. Cochrane Database Syst Rev. 2005;(2):CD001120. doi:10.1002/14651858.CD001120.pub2

Questions about this trial

What is this clinical trial studying?

A study testing StimolIrpinia-supported cognitive rehabilitation activities in people with Severe Acquired Brain Injury and Cognitive Impairment, run by Alfonso Magliacano at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alfonso Magliacano (393387389414, amagliacano@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient-reported System Usability Scale score for StimolIrpinia (time frame: Day 15, after completion of the 2-week intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07718321, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.

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