Efficacy and Safety of Immersive Virtual Reality for Post-stroke Cognitive Impairment (EVRPSC)

November 23, 2024 updated by: Dingqun Bai

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Diagnosis of stroke by neuroimaging (CT or MRI) assessment
  2. 18-85 years old
  3. Be able to follow instructions to complete the test
  4. Can tolerate the rehabilitation training of this experiment
  5. First stroke
  6. Patients who signed informed consent

Exclusion Criteria:

  1. The test could not be tolerated due to organic disease
  2. There is a serious mental illness resulting in inability to cooperate with or tolerate this test
  3. is participating in another clinical trial involving an investigational drug or physical therapy
  4. Patients who have not signed informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VR group (virtual reality cognitive training group)
Immersive VR cognitive training with suitable training intensity.
Device: immersive VR pathfinding training
Pathfinding training with immersive VR.
Active Comparator: OT group (occupational therapy group)
Conventional cognitive training (occupational therapy) with suitable training intensity.
Other: Occupational therapy
Only receive conventional cognitive training group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1. finished in 3 days before training. 2. finished 3 days after 30-days training
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.
1. finished in 3 days before training. 2. finished 3 days after 30-days training
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).
1. finished in 3 days before training. 2. finished 3 days after 30-days training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dingqun Bai

Investigators

  • Study Chair: Dingqun Bai, First Affiliated Hospital of Chongqing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

November 21, 2024

First Submitted That Met QC Criteria

November 23, 2024

First Posted (Estimated)

November 26, 2024

Study Record Updates

Last Update Posted (Estimated)

November 26, 2024

Last Update Submitted That Met QC Criteria

November 23, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20241120

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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