StrokeEVRPSCNCT06704360
Efficacy and Safety of Immersive Virtual Reality for Post-stroke Cognitive Impairment
A study testing immersive VR pathfinding training and Occupational therapy in people with Stroke and Cognitive Decline, run by Dingqun Bai.
Trial summary
This is a single-blind randomized controlled trial to evaluate the efficacy and safety of immersive virtual reality for post-stroke cognitive impairment. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Cognitive Decline
- What is being tested?
- immersive VR pathfinding training and Occupational therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of stroke by neuroimaging (CT or MRI) assessment
- 18-85 years old
- Be able to follow instructions to complete the test
- Can tolerate the rehabilitation training of this experiment
- First stroke
- Patients who signed informed consent
Who cannot join
- The test could not be tolerated due to organic disease
- There is a serious mental illness resulting in inability to cooperate with or tolerate this test
- is participating in another clinical trial involving an investigational drug or physical therapy
- Patients who have not signed informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-blind Randomized Controlled Trial to Evaluate Efficacy and Safety of Immersive Virtual Reality for Post-stroke Cognitive Impairment
This is a single-blind randomized controlled trial to evaluate the efficacy and safety of immersive virtual reality for post-stroke cognitive impairment.
Read the detailed description
This is a single-blind randomized controlled intervention study. Each stroke subject will undergo screening period, baseline assessment period, intervention period, endpoint assessment period.
In the screening period, the verification of inclusion/exclusion criteria and the acquisition of informed consent will be completed.
In the baseline assessment period and endpoint assessment period, cognitive function related scale assessment included Mental State Examination Scale (MMSE), Montreal Cognitive Assessment (MoCA), drawing clock test (DCT), Shape trials test A.B (STT-A, STT-B), standardized digital modal test (SDMT), auditory verbal learning test-Huashan version (AVLT-H), and activity of daily living (ADL) scale will be used to evaluate the function of each patient. Meanwhile, brain functional activation of each patient during the cognitive task (Stroop task, 1-back task and verbal fluency test) will be evaluated using functional near-infrared spectroscopy (fNIRS).
In the intervention period, the VR group will receive immersive VR cognitive training with suitable for training intensity and the control group will receive the conventional cognitive train (occupational therapy) with suitable for training intensity in the control group. The training will lasted 20 minutes per time, 5 times per week for four weeks, with a total of 600 minutes, training frequency will be adjusted according to the patient's own conditions.
- Conditions
- Stroke, Cognitive Decline
- Being tested
- immersive VR pathfinding training, Occupational therapy
- Keywords
- stroke, virtual reality, fNIRS, cognitive impairment
- Medical subject headings
- Stroke, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immersive VR pathfinding trainingDevice
Pathfinding training with immersive VR.
Occupational therapyOther
Only receive conventional cognitive training group
| Study group | Role | What they receive |
|---|---|---|
| VR group (virtual reality cognitive training group) | Experimental | Immersive VR cognitive training with suitable training intensity. Receives: Device: immersive VR pathfinding training |
| OT group (occupational therapy group) | Active comparator | Conventional cognitive training (occupational therapy) with suitable training intensity. Receives: Other: Occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental State Examination Scale (MMSE)
Global cognitive function assessment. Easy to use and one of the most used scales to screen person with cognitive impairment in the world. The minimum and maximum values range from 0 to 30. Higher score means better cognition level.
Measured: 1. finished in 3 days before training. 2. finished 3 days after 30-days training
Montreal Cognitive Assessment (MoCA)
one of the most used scales to assess cognition and screen person with cognitive impairment in the world. The minimum and maximum values range from 0 to 30. Higher score means better cognition level.
Measured: 1. finished in 3 days before training. 2. finished 3 days after 30-days training
Brain functional activation (fNIRS)
Brain functional activation of each patient during the cognitive task (Stroop task, 1-back task and verbal fluency test) will be evaluated using functional near-infrared spectroscopy (fNIRS).
Measured: 1. finished in 3 days before training. 2. finished 3 days after 30-days training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Nov 2025 (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 StrokeStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dingqun Bai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dingqun Bai, First Affiliated Hospital of Chongqing Medical University
- Investigators
- Dingqun Bai, Study chair, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704360
- Sponsor's protocol ID
- 20241120
- Acronym
- EVRPSC
- Status last verified
- Nov 2024
- First submitted
- 21 Nov 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blind Randomized Controlled Trial to Evaluate Efficacy and Safety of Immersive Virtual Reality for Post-stroke Cognitive Impairment
- ClinicalTrials.gov ID
- NCT06704360
- Acronym / sponsor ID
- EVRPSC / 20241120
- Conditions
- Stroke, Cognitive Decline
- Keywords
- stroke, virtual reality, fNIRS, cognitive impairment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Dingqun BaiUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 26 Nov 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 is a single-blind randomized controlled trial to evaluate the efficacy and safety of immersive virtual reality for post-stroke cognitive impairment.
Detailed description
This is a single-blind randomized controlled intervention study. Each stroke subject will undergo screening period, baseline assessment period, intervention period, endpoint assessment period.
In the screening period, the verification of inclusion/exclusion criteria and the acquisition of informed consent will be completed.
In the baseline assessment period and endpoint assessment period, cognitive function related scale assessment included Mental State Examination Scale (MMSE), Montreal Cognitive Assessment (MoCA), drawing clock test (DCT), Shape trials test A.B (STT-A, STT-B), standardized digital modal test (SDMT), auditory verbal learning test-Huashan version (AVLT-H), and activity of daily living (ADL) scale will be used to evaluate the function of each patient. Meanwhile, brain functional activation of each patient during the cognitive task (Stroop task, 1-back task and verbal fluency test) will be evaluated using functional near-infrared spectroscopy (fNIRS).
In the intervention period, the VR group will receive immersive VR cognitive training with suitable for training intensity and the control group will receive the conventional cognitive train (occupational therapy) with suitable for training intensity in the control group. The training will lasted 20 minutes per time, 5 times per week for four weeks, with a total of 600 minutes, training frequency will be adjusted according to the patient's own conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR group (virtual reality cognitive training group) | Experimental | Device: immersive VR pathfinding trainingImmersive VR cognitive training with suitable training intensity. |
| OT group (occupational therapy group) | Active comparator | Other: Occupational therapyConventional cognitive training (occupational therapy) with suitable training intensity. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of stroke by neuroimaging (CT or MRI) assessment
- 18-85 years old
- Be able to follow instructions to complete the test
- Can tolerate the rehabilitation training of this experiment
- First stroke
Key exclusion criteria (4 listed)
- The test could not be tolerated due to organic disease
- There is a serious mental illness resulting in inability to cooperate with or tolerate this test
- is participating in another clinical trial involving an investigational drug or physical therapy
- Patients who have not signed informed consent
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 |
|---|---|---|
| immersive VR pathfinding trainingPathfinding training with immersive VR. | Device | VR group (virtual reality cognitive training group) |
| Occupational therapyOnly receive conventional cognitive training group | Other | OT group (occupational therapy group) |
Primary outcome
Mental State Examination Scale (MMSE)
Time frame: 1. finished in 3 days before training. 2. finished 3 days after 30-days training
Global cognitive function assessment. Easy to use and one of the most used scales to screen person with cognitive impairment in the world. The minimum and maximum values range from 0 to 30. Higher score means better cognition level.
Montreal Cognitive Assessment (MoCA)
Time frame: 1. finished in 3 days before training. 2. finished 3 days after 30-days training
one of the most used scales to assess cognition and screen person with cognitive impairment in the world. The minimum and maximum values range from 0 to 30. Higher score means better cognition level.
Brain functional activation (fNIRS)
Time frame: 1. finished in 3 days before training. 2. finished 3 days after 30-days training
Brain functional activation of each patient during the cognitive task (Stroop task, 1-back task and verbal fluency test) will be evaluated using functional near-infrared spectroscopy (fNIRS).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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.
Dingqun Bai study chair
First Affiliated Hospital of Chongqing Medical University
Questions about this trial
What is this clinical trial studying?
A study testing immersive VR pathfinding training and Occupational therapy in people with Stroke and Cognitive Decline, run by Dingqun Bai.
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 4 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: opening soon, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dingqun Bai (023-89011334, baidingqun2014@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental State Examination Scale (MMSE) (time frame: 1. finished in 3 days before training. 2. finished 3 days after 30-days training). 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?
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 26 Nov 2024.