Cognitive Remediation VR Tool for People With MCI: a Feasibility RCT

University of Cagliari

Status: Not yet enrolling

Conditions: Psychiatric Rehabilitation; Mild Cognitive Impairment; Cognitive Remediation; Virtual Reality

Treatments: Device: Virtual Reality Cognitive Remediation

Study type: Interventional

Funder types: Other

Identifiers

NCT06270966

28287 08/11/2023

Details and patient eligibility

About

The need to promote research in active aging trough multidisciplinary and innovative approaches is strongly indicated by the European Union. Our study aims to assess the feasibility and provide a preliminary measure of effectiveness for an intervention using immersive virtual reality (VR) technology for cognitive remediation (CR) in individuals with Mild Cognitive Impairment (MCI)

Full description

The European Union emphasizes the need to promote research in active aging trough multidisciplinary and innovative approaches, addressing challenges related to neurodegenerative diseases in old adults. Our study aims to assess the feasibility and provide a preliminary measure of effectiveness for an intervention using immersive virtual reality (VR) technology for cognitive remediation (CR) in individuals with Mild Cognitive Impairment (MCI).

Methods: A feasibility randomized controlled clinical trial will involve 30 individuals who are over 65 years old, both sex, who have received the diagnosis of MCI, randomly assigned to experimental condition or control group. Both groups will continue to receive standard pharmacological therapy (TAU). The experimental group will undergo a 3-months cognitive remediation program with fully immersive VR with two sessions per week (each session of sixty minutes). The control group will continue with TAU.

Feasibility will be assessed based on tolerability, including dropout rates and acceptability, (proportion of recruited participants among those considered eligible) and side effects. The preliminary measures of effectiveness will be evaluated on cognitive functions, quality of life, biological and social rhythms, anxiety and depressive.

Enrollment: 30 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 65 and above, a diagnosis of MCI based on DSM-IV criteria [American Psychiatric Association, 2000]

Exclusion criteria

• failure to meet inclusion criteria, a diagnosis of epilepsy or severe visual impairments due to potential risks associated with extensive virtual reality stimulation, and severe illnesses impeding bi-weekly intervention attendance

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Virtual Reality Cognitive Remediation + treatment as usual

Experimental group

Description:

15 Participants with more than 65 years and with MCI diagnosis will undergo a cognitive remediation program using fully immersive VR. Participants will continue with standard care during the experimental intervention

Treatment:

Device: Virtual Reality Cognitive Remediation

Treatment as usual

No Intervention group

Description:

The control group, 15 participants with more than 65 years and with MCI diagnosis, will continue with standard care.