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

NCT06704360 | Not Yet Recruiting

• 1 other identifier: 20241120
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single-blind randomized controlled trial to evaluate the efficacy and safety of immersive virtual reality for post-stroke cognitive impairment.

Conditions

Stroke; Cognitive Decline

Keywords

stroke; virtual reality; fNIRS; cognitive impairment

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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).

  1. finished in 3 days before training. 2. finished 3 days after 30-days training

Study Arms (2)

VR group (virtual reality cognitive training group)

EXPERIMENTAL

Immersive VR cognitive training with suitable training intensity.

Device: immersive VR pathfinding training

OT group (occupational therapy group)

ACTIVE COMPARATOR

Conventional cognitive training (occupational therapy) with suitable training intensity.

Other: Occupational therapy

Interventions

immersive VR pathfinding training DEVICE

Pathfinding training with immersive VR.

VR group (virtual reality cognitive training group)

Occupational therapy OTHER

Only receive conventional cognitive training group

OT group (occupational therapy group)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of stroke by neuroimaging (CT or MRI) assessment
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dingqun Bai: lead

MeSH Terms

Conditions

Stroke; Cognitive Dysfunction

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Dingqun Bai

  First Affiliated Hospital of Chongqing Medical University

  STUDY CHAIR

Central Study Contacts

Dingqun Bai

CONTACT

023-89011334; baidingqun2014@163.com

Defei Chen

CONTACT

+8615188017034; 2283273437@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of rehabilitation Medicine

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 26, 2024
• Study Start: December 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 26, 2024

Record last verified: 2024-11