Mild Cognitive ImpairmentNCT06313931
Effects of Cognitive-motor Training on Cognition, Depression and Daily Functioning in Patients With Mild Cognitive Impairment (MCI)
A study testing cognitive training via immersive virtual reality, cognitive training via paper and pencil and motor stimulation in people with Mild Cognitive Impairment, run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
This randomized controlled trial evaluated the effectiveness of an immersive virtual reality (IVR) application (focused on a daily activity) to train cognitive functions and its impact on depression and the ability to perform activities of daily living (ADL) in patients with mild cognitive impairment (MCI). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- cognitive training via immersive virtual reality, cognitive training via paper and pencil and motor stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSpain
- Study dates
- 3 Jul 2023to 14 Sep 2023
- 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 or older
- Community-dwelling, not in nursing homes
- Physically functional
- Understanding and voluntary consent
- Mild Cognitive Impairment (MCI)
- MoCA score of 19-25
Who cannot join
- Clinical dementia diagnosis
- MoCA ≤ 18 indicating probable dementia
- Neurological disorders including stroke or TBI in the last year
- History of mental/psychiatric disorders
- Substance abuse
- Difficulty using VR headset and controllers
Show all 9Show fewer
- Medical conditions affecting trial participation
- Visual/hearing impairments
- Communication difficulties
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Cognitive-motor Training on Cognition, Depression and Daily Functioning in Patients With Mild Cognitive Impairment (MCI): A Randomized Controlled Trial
This randomized controlled trial evaluated the effectiveness of an immersive virtual reality (IVR) application (focused on a daily activity) to train cognitive functions and its impact on depression and the ability to perform activities of daily living (ADL) in patients with mild cognitive impairment (MCI). With a dose of two sessions per week during six weeks, the study showed significant improvements in cognitive functions and reduction in depression, with notable effects in the experimental group. This underscores the potential of IVR as a valuable tool in the management of MCI.
Read the detailed description
Background:
The increase in cases of MCI underlines the urgency of finding effective methods to slow its progression. Given the limited effectiveness of current pharmacological options to prevent or treat the early stages of this deterioration, non-pharmacological alternatives are especially relevant.
Aim: The study aimed to evaluate the effectiveness of an immersive virtual reality (IVR) application, focused on an activity of daily living (ADL), to train cognitive functions and its impact on depression and the ability to perform ADL in patients with MCI. IVR is presented as an innovative tool with the potential to offer a promising non-pharmacological approach.
Methods:The researchers implemented a 40-minute-long intervention, twice a week for six weeks (totaling 12 sessions), using the cupboard task (based on IVR). The study included the participation of individuals with MCI, randomly distributed into control (n=12) and experimental (n=14) groups. The majority in the control group were women (75%), with a mean age of 77.67 years, and in the experimental group, women represented 57.14%, with a mean age of 74.86 years. Cognitive functions, depression, and the ability to perform ADLs were assessed. The scales used were: the Spanish version of the Montreal Cognitive Assessment (MoCA-S), the Short Geriatric Depression Scale (SGDS-S) and the Instrumental Activities of Daily Living Scale. (IADL-S), respectively.
- Conditions
- Mild Cognitive Impairment
- Being tested
- cognitive training via immersive virtual reality, cognitive training via paper and pencil, motor stimulation
- Keywords
- Mild Cognitive Impairment, Immersive Virtual Reality, Instrumental Activities of Daily Living, Motor-cognitive Training, Geriatric Depression
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive training via immersive virtual realityDevice
20 minutes per session, twice a week for six weeks (totaling 12 sessions), using the cupboard task application.
cognitive training via paper and pencilOther
20 minutes per session, twice a week for six weeks (totaling 12 sessions), using cards.
motor stimulationOther
motor stimulation for 12 sessions (20 minutes per session)
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Experimental group Receives: Device: cognitive training via immersive virtual reality; Other: motor stimulation |
| Control group | Active comparator | Control group Receives: Other: cognitive training via paper and pencil; Other: motor stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spanish version of the Montreal Cognitive Assessment (MoCA-S)
Scores in the MoCA-S scale. Higher scores mean a better outcome.
Measured: 6 weeks
Short Geriatric Depression Scale (SGDS-S)
Scores in the SGDS scale. Higher scores mean a worse outcome.
Measured: 6 weeks
Instrumental Activities of Daily Living Scale (IADL-S)
Scores in the IADL scale. Higher scores mean a better outcome.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start3 Jul 2023
- Primary completion14 Sep 2023
- Study completion14 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillermo Palacios, Universidad de Zaragoza
- Investigators
- Guillermo Palacios, PhD, Principal investigator, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313931
- Sponsor's protocol ID
- UTI-IIDI-074-2023
- Status last verified
- Mar 2024
- First submitted
- 1 Mar 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Buele J, Aviles-Castillo F, Del-Valle-Soto C, Varela-Aldas J, Palacios-Navarro G. Effects of a dual intervention (motor and virtual reality-based cognitive) on cognition in patients with mild cognitive impairment: a single-blind, randomized controlled trial. J Neuroeng Rehabil. 2024 Aug 1;21(1):130. doi: 10.1186/s12984-024-01422-w.
PubMed 39090664
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cognitive-motor Training on Cognition, Depression and Daily Functioning in Patients With Mild Cognitive Impairment (MCI): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06313931
- Acronym / sponsor ID
- UTI-IIDI-074-2023
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild Cognitive Impairment, Immersive Virtual Reality, Instrumental Activities of Daily Living, Motor-cognitive Training, Geriatric Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 14 Sep 2023 (actual)
- Study completion
- 14 Sep 2023 (actual)
- First posted
- 15 Mar 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.
This randomized controlled trial evaluated the effectiveness of an immersive virtual reality (IVR) application (focused on a daily activity) to train cognitive functions and its impact on depression and the ability to perform activities of daily living (ADL) in patients with mild cognitive impairment (MCI). With a dose of two sessions per week during six weeks, the study showed significant improvements in cognitive functions and reduction in depression, with notable effects in the experimental group. This underscores the potential of IVR as a valuable tool in the management of MCI.
Detailed description
Background:
The increase in cases of MCI underlines the urgency of finding effective methods to slow its progression. Given the limited effectiveness of current pharmacological options to prevent or treat the early stages of this deterioration, non-pharmacological alternatives are especially relevant.
Aim: The study aimed to evaluate the effectiveness of an immersive virtual reality (IVR) application, focused on an activity of daily living (ADL), to train cognitive functions and its impact on depression and the ability to perform ADL in patients with MCI. IVR is presented as an innovative tool with the potential to offer a promising non-pharmacological approach.
Methods:The researchers implemented a 40-minute-long intervention, twice a week for six weeks (totaling 12 sessions), using the cupboard task (based on IVR). The study included the participation of individuals with MCI, randomly distributed into control (n=12) and experimental (n=14) groups. The majority in the control group were women (75%), with a mean age of 77.67 years, and in the experimental group, women represented 57.14%, with a mean age of 74.86 years. Cognitive functions, depression, and the ability to perform ADLs were assessed. The scales used were: the Spanish version of the Montreal Cognitive Assessment (MoCA-S), the Short Geriatric Depression Scale (SGDS-S) and the Instrumental Activities of Daily Living Scale. (IADL-S), respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: cognitive training via immersive virtual reality, Other: motor stimulationExperimental group |
| Control group | Active comparator | Other: cognitive training via paper and pencil, Other: motor stimulationControl group |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Age 65 or older
- Community-dwelling, not in nursing homes
- Physically functional
- Understanding and voluntary consent
- Mild Cognitive Impairment (MCI)
Key exclusion criteria (9 listed)
- Clinical dementia diagnosis
- MoCA ≤ 18 indicating probable dementia
- Neurological disorders including stroke or TBI in the last year
- History of mental/psychiatric disorders
- Substance abuse
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 |
|---|---|---|
| cognitive training via immersive virtual reality20 minutes per session, twice a week for six weeks (totaling 12 sessions), using the cupboard task application. | Device | Experimental group |
| cognitive training via paper and pencil20 minutes per session, twice a week for six weeks (totaling 12 sessions), using cards. | Other | Control group |
| motor stimulationmotor stimulation for 12 sessions (20 minutes per session) | Other | Control group, Experimental group |
Primary outcome
Spanish version of the Montreal Cognitive Assessment (MoCA-S)
Time frame: 6 weeks
Scores in the MoCA-S scale. Higher scores mean a better outcome.
Short Geriatric Depression Scale (SGDS-S)
Time frame: 6 weeks
Scores in the SGDS scale. Higher scores mean a worse outcome.
Instrumental Activities of Daily Living Scale (IADL-S)
Time frame: 6 weeks
Scores in the IADL scale. Higher scores mean a better outcome.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Derived from this study: PubMed 39090664Buele J, Aviles-Castillo F, Del-Valle-Soto C, Varela-Aldas J, Palacios-Navarro G. Effects of a dual intervention (motor and virtual reality-based cognitive) on cognition in patients with mild cognitive impairment: a single-blind, randomized controlled trial. J Neuroeng Rehabil. 2024 Aug 1;21(1):130. doi: 10.1186/s12984-024-01422-w.
- Individual participant dataSharing planned: No
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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.
Guillermo Palacios, PhD principal investigator
Universidad de Zaragoza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive training via immersive virtual reality, cognitive training via paper and pencil and motor stimulation in people with Mild Cognitive Impairment, run by Universidad de Zaragoza at 1 site in Spain.
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 6 inclusion and 9 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: finished, as of the sponsor's last update on 15 Mar 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Spanish version of the Montreal Cognitive Assessment (MoCA-S) (time frame: 6 weeks). The study lists 3 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 NCT06313931, 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 15 Mar 2024.