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NCT Number: NCT06704360

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

immersive VR pathfinding training

Device

Pathfinding training with immersive VR.

Occupational Therapy

Other

Only receive conventional cognitive training group

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Defei Chen

CONTACT

[email protected]

+8615188017034

Dingqun Bai

CONTACT

[email protected]

023-89011334

Sponsors and collaborators

Lead sponsor

Dingqun Bai

Other

Registry information

Official study title

A Single-blind Randomized Controlled Trial to Evaluate Efficacy and Safety of Immersive Virtual Reality for Post-stroke Cognitive Impairment

Acronym: EVRPSC

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 26, 2024
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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