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Search / Trial NCT06693193

Personalized Virtual Environments for Managing Responsive Behaviors in Cognitively Impaired Patients: a Feasibility Study

Launched by FONDAZIONE BRUNO KESSLER · Nov 15, 2024

Trial Information

Current as of October 26, 2025

Not yet recruiting

Keywords

Customization Customized Virtual Reality Scenarios Cognitive Impairment Responsive Behaviors Virtual Reality Therapy Non Pharmacological Therapy

ClinConnect Summary

This clinical trial is exploring the use of virtual reality (VR) technology to help manage challenging behaviors in older adults with cognitive impairments, such as dementia. The goal is to see if these realistic and customizable VR environments can positively influence the way patients respond during specific situations that may trigger them, like personal hygiene activities. Researchers will look at how well participants accept using VR, how safe it is, and how much they enjoy the experience.

To be eligible for this study, participants must be at least 18 years old, speak Italian, and be able to give consent or have a legal guardian who can. However, individuals with certain medical conditions, such as severe psychiatric disorders or significant neurological issues, will not be able to participate. During the trial, participants will experience three VR sessions at different times related to their behavior triggers. The study will carefully monitor their experiences to ensure safety and engagement. Overall, this trial aims to see if VR can be a helpful tool in supporting individuals with cognitive challenges.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Adults over 18 years of age.
  • Native Italian speakers.
  • Can provide written informed consent for study participation or have a legal guardian who can give consent on their behalf.
  • Exclusion Criteria:
  • Presence of any psychiatric diagnoses as recorded in medical records.
  • A total score of ≥ 40 on the Neuropsychiatric Inventory (NPI) indicates neuropsychiatric symptoms.
  • A partial NPI score \> 6 in the domains of agitation/aggression or delusions.
  • Enrollment in palliative care services.
  • Severe neurological damage, a positive diagnosis of epilepsy, or having first-degree relatives diagnosed with epilepsy.
  • Presence of a cardiac pacemaker or other metallic devices.
  • Infectious or gastrointestinal disorders.
  • Open facial wounds, motor or visual impairments, or neuromuscular pain that would prevent using the Oculus VR headset.
  • Refusal to consent, either by the individual or their legal representative, for study participation.

About Fondazione Bruno Kessler

Fondazione Bruno Kessler (FBK) is a renowned research institute based in Trento, Italy, dedicated to advancing scientific knowledge and technological innovation across various domains, including health, information technology, and social sciences. As a clinical trial sponsor, FBK leverages its interdisciplinary expertise and collaborative networks to design and execute cutting-edge research initiatives aimed at improving healthcare outcomes. With a strong commitment to ethical standards and rigorous methodologies, FBK strives to translate research findings into practical applications that benefit society and enhance the quality of life for individuals.

Locations

Trento, Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported