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

Mild Cognitive Impairment Clinical Trial

Official title:

Cognitive Remediation Virtual Reality Tool a Recovery-oriented Project for People With Mild Cognitive Impairment: a Feasibility Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06270966
• Other study ID #: 28287 08/11/2023
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 7, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: February 2024
• Source: University of Cagliari
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Remediation
• Mild Cognitive Impairment
• Psychiatric Rehabilitation
• Virtual Reality

Intervention

Device:
• Virtual Reality Cognitive Remediation
Participants will undergo a 3-months cognitive remediation program using fully immersive VR with two sessions per week. Each session will last a maximum of sixty minutes and will be supervised by expert health professionals. The experimental group participated in an immersive VR-based CR program using the "CEREBRUM" software designed by clinicians and experts specializing in cognitive rehabilitation. CEREBRUM provides 52 exercises: Attention, Working Memory, Memory and Learning and Cognitive Estimates. The intervention included 24 sessions.

Locations

Country	Name	City	State
Italy	San Giovanni di Dio Hospital	Cagliari	CA

Sponsors (1)

Lead Sponsor	Collaborator
University of Cagliari

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Side effects; Dropout rates; Proportion of recruited participants among those considered eligible	Feasibility will be assessed based on tolerability, including dropout rates and acceptability, which considers the proportion of recruited participants among those considered eligible and side effects.	T0 (0 weeks); T1 (12 weeks)
Secondary	Short Form Health Survey, 12 items (SF-12)	Preliminary measures of effectiveness on quality of life, 12 items	T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Secondary	Brief Social Rhythms Scale (BSRS)	Preliminary measures of effectiveness on biological and social rhythms, 10 items	T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Secondary	Patient Health Questionnaire (PHQ-9)	Preliminary measures of effectiveness on depressive symptoms, 9 Items	T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Secondary	Generalized Anxiety Disorder-7 item (GAD-7)	Preliminary measures of effectiveness on anxiety, 7 items	T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Secondary	Addenbrooke's Cognitive Examination (ACE-R)	Preliminary measures of effectiveness on general cognitive functions, the neuropsychological tests is used to identify cognitive impairment in conditions such as dementia.	T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Secondary	Matrix test	Preliminary measures of effectiveness on attention	T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Secondary	Rey's Word Test	Preliminary measures of effectiveness on memory	T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Secondary	Trail Making Test (TMT)	Preliminary measures of effectiveness on executive function	T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Secondary	Digit Span	Preliminary measures of effectiveness on memory	T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Secondary	Stroop Test	Preliminary measures of effectiveness on executive function	T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Secondary	Frontal Assessment Battery (FAB)	Preliminary measures of effectiveness on executive function	T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Secondary	Cognitive Estimates Test (CET)	Preliminary measures of effectiveness on executive function	T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Secondary	Rey Figure Test	Preliminary measures of effectiveness on visual spatial function	T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)