Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-31 @ 11:36 AM
Study NCT ID:
NCT06704360
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-26
First Post:
2024-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Immersive Virtual Reality for Post-stroke Cognitive Impairment
Sponsor:
Dingqun Bai
Organization:
Study Overview
Official Title:
A Single-blind Randomized Controlled Trial to Evaluate Efficacy and Safety of Immersive Virtual Reality for Post-stroke Cognitive Impairment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EVRPSC
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.
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: