Mild Cognitive ImpairmentNCT06270966
Cognitive Remediation VR Tool for People With MCI: a Feasibility RCT
A study testing Virtual Reality Cognitive Remediation in people with Mild Cognitive Impairment and Cognitive Remediation, run by University of Cagliari at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Cognitive Remediation, Virtual Reality
- What is being tested?
- Virtual Reality Cognitive Remediation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 7 Mar 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- age 65 and above, a diagnosis of MCI based on DSM-IV criteria [American Psychiatric Association, 2000]
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Remediation Virtual Reality Tool a Recovery-oriented Project for People With Mild Cognitive Impairment: a Feasibility Randomized Clinical Trial
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)
Read the detailed 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.
- Conditions
- Mild Cognitive Impairment, Cognitive Remediation, Virtual Reality, Psychiatric Rehabilitation
- Being tested
- Virtual Reality Cognitive Remediation
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Cognitive RemediationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Cognitive Remediation + treatment as usual | Experimental | 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 Receives: Device: Virtual Reality Cognitive Remediation |
| Treatment as usual | No intervention | The control group, 15 participants with more than 65 years and with MCI diagnosis, will continue with standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: T0 (0 weeks); T1 (12 weeks)
Secondary outcomes (13)
Short Form Health Survey, 12 items (SF-12)
Preliminary measures of effectiveness on quality of life, 12 items
Measured: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Brief Social Rhythms Scale (BSRS)
Preliminary measures of effectiveness on biological and social rhythms, 10 items
Measured: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Patient Health Questionnaire (PHQ-9)
Preliminary measures of effectiveness on depressive symptoms, 9 Items
Measured: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Generalized Anxiety Disorder-7 item (GAD-7)
Preliminary measures of effectiveness on anxiety, 7 items
Measured: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
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.
Measured: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Matrix test
Preliminary measures of effectiveness on attention
Measured: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Rey's Word Test
Preliminary measures of effectiveness on memory
Measured: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Trail Making Test (TMT)
Preliminary measures of effectiveness on executive function
Measured: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Digit Span
Preliminary measures of effectiveness on memory
Measured: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Stroop Test
Preliminary measures of effectiveness on executive function
Measured: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Frontal Assessment Battery (FAB)
Preliminary measures of effectiveness on executive function
Measured: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Cognitive Estimates Test (CET)
Preliminary measures of effectiveness on executive function
Measured: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Rey Figure Test
Preliminary measures of effectiveness on visual spatial function
Measured: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start7 Mar 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro Giovanni Carta, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270966
- Sponsor's protocol ID
- 28287 08/11/2023
- Status last verified
- Feb 2024
- First submitted
- 13 Feb 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Remediation Virtual Reality Tool a Recovery-oriented Project for People With Mild Cognitive Impairment: a Feasibility Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06270966
- Acronym / sponsor ID
- 28287 08/11/2023
- Conditions
- Mild Cognitive Impairment, Cognitive Remediation, Virtual Reality, Psychiatric Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Study start
- 7 Mar 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Cognitive Remediation + treatment as usual | Experimental | Device: Virtual Reality Cognitive Remediation15 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 as usual | No intervention | –The control group, 15 participants with more than 65 years and with MCI diagnosis, will continue with standard care. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- age 65 and above, a diagnosis of MCI based on DSM-IV criteria [American Psychiatric Association, 2000]
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Cognitive RemediationParticipants 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. | Device | Virtual Reality Cognitive Remediation + treatment as usual |
Primary outcome
Side effects; Dropout rates; Proportion of recruited participants among those considered eligible
Time frame: T0 (0 weeks); T1 (12 weeks)
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.
13 secondary outcomes
Short Form Health Survey, 12 items (SF-12)
Time frame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Brief Social Rhythms Scale (BSRS)
Time frame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Patient Health Questionnaire (PHQ-9)
Time frame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Generalized Anxiety Disorder-7 item (GAD-7)
Time frame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Addenbrooke's Cognitive Examination (ACE-R)
Time frame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Matrix test
Time frame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Rey's Word Test
Time frame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Trail Making Test (TMT)
Time frame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Digit Span
Time frame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Stroop Test
Time frame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Frontal Assessment Battery (FAB)
Time frame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Cognitive Estimates Test (CET)
Time frame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Rey Figure Test
Time frame: T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Cognitive Remediation in people with Mild Cognitive Impairment and Cognitive Remediation, run by University of Cagliari 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?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 21 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Side effects; Dropout rates; Proportion of recruited participants among those considered eligible (time frame: T0 (0 weeks); T1 (12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2024.