Mild Cognitive ImpairmentVRMCINCT04045483
Virtual Reality Based Cognitive Training Program in Mild Cognitive Impairment
A study testing Virtual reality based cognitive training in people with Mild Cognitive Impairment, run by Inha University Hospital at 2 sites in South Korea.
Trial summary
This study evaluates efficacy and safety of virtual reality (VR)-based cognitive training program in amnestic mild cognitive impairment. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Virtual reality based cognitive training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 7 Jun 2019to 14 Mar 2020
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 50-85
- A memory complaint by a participant or caregiver
- Objective memory decline as defined by a delayed recall score of verbal learning test or logical memory worse than 1.0 standard deviations (SD) below age and education-adjusted normative mean
- MMSE score better than1.5 SD below age and education-adjusted normative means
- Global Clinical Dementia Rating (CDR) scale of 0.5 and memory score of CDR 0.5 or 1
- Preserved activities of daily living (ADL), as defined by Korean Instrumental Activities of Daily Living < 0.4
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- Not demented
- Hachinski Ischemic Score ≤ 4
- Can read and write Korean
- brain MRI or CT showing no other diseases capable of producing cognitive impairment
- Having a reliable informant who could provide investigators with the requested information.
- Provide written informed consent
Who cannot join
- Participated in another clinical trial within the past 4 weeks
- Other serious or unstable medical disease such as acute or severe asthma, severe or unstable cardiovascular disease, active gastric ulcer, severe liver disease, or severe renal disease
- A clinically significant laboratory abnormality, such as an abnormal thyroid function test, abnormal low levels of vitamin B12 or folate, and positive syphilis serology
- A primary other neurodegenerative disorder
- Major psychiatric illness such as major depressive disorders
- Drug or alcohol addiction during the past 10 years
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- Severe loss of vision, hearing, or communicative disability
- Malignancy within 5 years
- Any conditions preventing cooperation as judged by the study physician
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Recruiting
Inha University Hospital
Incheon, 22332
Seong Hye Choi, MD, PhD, seonghye@inha.ac.kr
Hye Lan Na, RN, nhyelan@hanmail.net
- Not yet recruiting
Ewha Womans University Mokdong Hospital
Seoul
Jee Hyang Jeong, MD, PhD
Jee Hyang Jeong, MD
About this study
Official title: A Randomized Controlled Crossover Trial to Assess Efficacy of Virtual Reality Based Cognitive Training Program in Mild Cognitive Impairment
This study evaluates efficacy and safety of virtual reality (VR)-based cognitive training program in amnestic mild cognitive impairment.
Read the detailed description
This study is a single-blind, randomized, controlled, two-period crossover trial. The intervention is done twice a week for 6 weeks. There are two arms. During the first period, participants were randomized to receive either VR-based cognitive training or usual care. After a 2-week washout period, the groups were crossed over to receive the alternative treatment for 6 weeks.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Virtual reality based cognitive training
- Keywords
- virtual reality
- 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 based cognitive trainingOther
The VR-based cognitive training consists of a three-dimensional simulation of home, a mart, bus stop, and street. It provides an integrative cognitive training experience where participants are required to accomplish some common ADL's in three frequently visited places: home, a supermarket, and bus stop.
| Study group | Role | What they receive |
|---|---|---|
| VR based cognitive training | Experimental | Participants perform the VR based cognitive training under the supervision of a research nurse or psychologist for 30 min per session, twice per week, over the 6-week intervention period. Receives: Other: Virtual reality based cognitive training |
| Usual care | No intervention | Participants take some medication for risk factors and cognitive impairment and receive health advice as a usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Short form of Literacy Independent Cognitive Assessment from baseline at 6 weeks
Measurement of memory, visuospatial function, language, and executive function The range of score is from 0 to 100. The higher score means better cognition.
Measured: 6 weeks
Secondary outcomes (6)
Change of Mini-Mental State Examination from baseline at 6 weeks
Evaluation of global cognition The range of score is from 0 to 30. The higher score means better cognition.
Measured: 6 weeks
Change of Clinical Dementia Rating Scale-Sum of Boxes from baseline at 6 weeks
Evaluation of global cognition The range of score is from 0 to 18. The higher score means better cognition.
Measured: 6 weeks
Change of Quality of life-Alzheimer's disease from baseline at 6 weeks
Evaluation of quality of life The range of score is from 0 to 52. The higher score means better quality of life.
Measured: 6 weeks
Change of Geriatric Depression Scale-15 items from baseline at 6 weeks
Evaluation of mood The range of score is from 0 to 15. A higher score means more depression.
Measured: 6 weeks
Change of Prospective and Retrospective Memory Questionnaire from baseline at 6 weeks
Evaluation of subjective memory The range of score is from 16 to 80. The higher score means more memory impairment.
Measured: 6 weeks
Change of Bayer Activities of Daily Living from baseline at 6 weeks
Evaluation of activities of daily living The range of score is from 1 to 10. The higher score means worse ADL.
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 posted5 Aug 2019
- Study start7 Jun 2019
- Primary completion28 Feb 2020 (estimated)
- Study completion14 Mar 2020 (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
- Crossover
- Model description
- This study is a single-blind, randomized, controlled, two-period crossover trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inha University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seong Hye Choi, MD, PhD, Principal investigator, Inha University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04045483
- Sponsor's protocol ID
- 2019-04-029
- Acronym
- VRMCI
- Status last verified
- Aug 2019
- First submitted
- 26 Jul 2019
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will decide it later.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Crossover Trial to Assess Efficacy of Virtual Reality Based Cognitive Training Program in Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT04045483
- Acronym / sponsor ID
- VRMCI / 2019-04-029
- Conditions
- Mild Cognitive Impairment
- Keywords
- virtual reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Inha University HospitalUniversity, hospital or other
- Study start
- 7 Jun 2019 (actual)
- Primary completion
- 28 Feb 2020 (estimated)
- Study completion
- 14 Mar 2020 (estimated)
- First posted
- 5 Aug 2019 (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 study evaluates efficacy and safety of virtual reality (VR)-based cognitive training program in amnestic mild cognitive impairment.
Detailed description
This study is a single-blind, randomized, controlled, two-period crossover trial. The intervention is done twice a week for 6 weeks. There are two arms. During the first period, participants were randomized to receive either VR-based cognitive training or usual care. After a 2-week washout period, the groups were crossed over to receive the alternative treatment for 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a single-blind, randomized, controlled, two-period crossover trial.
| Arm | Type | Receives |
|---|---|---|
| VR based cognitive training | Experimental | Other: Virtual reality based cognitive trainingParticipants perform the VR based cognitive training under the supervision of a research nurse or psychologist for 30 min per session, twice per week, over the 6-week intervention period. |
| Usual care | No intervention | –Participants take some medication for risk factors and cognitive impairment and receive health advice as a usual care. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Aged 50-85
- A memory complaint by a participant or caregiver
- Objective memory decline as defined by a delayed recall score of verbal learning test or logical memory worse than 1.0 standard deviations (SD) below age and education-adjusted normative mean
- MMSE score better than1.5 SD below age and education-adjusted normative means
- Global Clinical Dementia Rating (CDR) scale of 0.5 and memory score of CDR 0.5 or 1
Key exclusion criteria (9 listed)
- Participated in another clinical trial within the past 4 weeks
- Other serious or unstable medical disease such as acute or severe asthma, severe or unstable cardiovascular disease, active gastric ulcer, severe liver disease, or severe renal disease
- A clinically significant laboratory abnormality, such as an abnormal thyroid function test, abnormal low levels of vitamin B12 or folate, and positive syphilis serology
- A primary other neurodegenerative disorder
- Major psychiatric illness such as major depressive disorders
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 based cognitive trainingThe VR-based cognitive training consists of a three-dimensional simulation of home, a mart, bus stop, and street. It provides an integrative cognitive training experience where participants are required to accomplish some common ADL's in three frequently visited places: home, a supermarket, and bus stop. | Other | VR based cognitive training |
Primary outcome
Change of Short form of Literacy Independent Cognitive Assessment from baseline at 6 weeks
Time frame: 6 weeks
Measurement of memory, visuospatial function, language, and executive function The range of score is from 0 to 100. The higher score means better cognition.
6 secondary outcomes
Change of Mini-Mental State Examination from baseline at 6 weeks
Time frame: 6 weeks
Change of Clinical Dementia Rating Scale-Sum of Boxes from baseline at 6 weeks
Time frame: 6 weeks
Change of Quality of life-Alzheimer's disease from baseline at 6 weeks
Time frame: 6 weeks
Change of Geriatric Depression Scale-15 items from baseline at 6 weeks
Time frame: 6 weeks
Change of Prospective and Retrospective Memory Questionnaire from baseline at 6 weeks
Time frame: 6 weeks
Change of Bayer Activities of Daily Living from baseline at 6 weeks
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- Individual participant dataSharing planned: No. We will decide it later.
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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.
Seong Hye Choi, MD, PhD principal investigator
Inha University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality based cognitive training in people with Mild Cognitive Impairment, run by Inha University Hospital at 2 sites in South Korea.
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 12 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: status not confirmed, as of the sponsor's last update on 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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?
Contact Seong Hye Choi, MD, PhD (82 32 890 3659, seonghye@inha.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Short form of Literacy Independent Cognitive Assessment from baseline at 6 weeks (time frame: 6 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 5 Aug 2019; AzTrials last refreshed its copy on 28 Oct 2026.