Clinical trial NCT06704360: Efficacy and Safety of Immersive Virtual Reality for Post-stroke Cognitive Impairment
Official title: A Single-blind Randomized Controlled Trial to Evaluate Efficacy and Safety of Immersive Virtual Reality for Post-stroke Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Cognitive Decline
Keywords: stroke
virtual reality
fNIRS
cognitive impairment
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mental State Examination Scale (MMSE)
timeFrame: 1. finished in 3 days before training. 2. finished 3 days after 30-days training
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 1. finished in 3 days before training. 2. finished 3 days after 30-days training
measure: Brain functional activation (fNIRS)
timeFrame: 1. finished in 3 days before training. 2. finished 3 days after 30-days training
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Dingqun Bai
role: STUDY_CHAIR
References: