Clinical trial NCT06703320: Brain Activation Pattern Caused by Immersive Virtual Reality Pathfinding Task in Stroke Patients: an FNIRS Study
Official title: Brain Activation Pattern Caused by Immersive Virtual Reality Pathfinding Task in Stroke Patients: a Functional Near-infrared Spectroscopy Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Cognitive Decline
Keywords: stroke
virtual reality
cognitive impairment
fNIRS
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2024-11-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stroke in the inpatient ward of the Department of Rehabilitation Medicine, The First Affiliated Hospital of Chongqing Medical University.

Healthy subjects recruited through the Department of Rehabilitation Medicine, The First Affiliated Hospital of Chongqing Medical University.

Brief summary: This is an fNIRS study performed to investigate Brain Activation Pattern Caused by Immersive Virtual Reality Pathfinding Task in Stroke Patients.

Detailed description: This was an initial screening and preliminary intervention study. Both healthy subject and stroke patients will be included in this study. Brain functional activation of each subject during Immersive Virtual Reality Pathfinding Task will be evaluated using functional near-infrared spectroscopy (fNIRS). 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. Brain Activation Pattern Caused by Immersive Virtual Reality Pathfinding Task will be identified by by comparing differences in brain activation and brain network connectivity between patients and healthy subjects.

Eligibility criteria: Inclusion Criteria:

Stroke patients:

1. Diagnosis of stroke confirmed by neuroimaging (CT or MRI)
2. 18-80 years old
3. Able to complete the cognitive task
4. Able to follow instructions to complete the trial
5. Patients who signed an informed consent form.

Healthy Subjects:

1. No abnormalities on cranial
2. 18-80 years old
3. Able to complete cognitive task
4. Able to follow instructions to complete the trial
5. not taking medications.
6. Subjects who signed an informed consent form.

Exclusion Criteria:

Stroke patients:

1. Inability to tolerate the test due to organic diseases
2. Serious mental illness that prevents them from cooperating with or tolerating the trial
3. Pregnant or lactating women
4. Had metal implants, a history of other neurological disorders, acute cardiopulmonary dysfunction.

Healthy Subjects:

1. Inability to tolerate the test due to organic diseases
2. Serious mental illness that prevents them from cooperating with or tolerating the trial.
3. Pregnant or lactating women
4. Had metal implants, a history of other neurological disorders, acute cardiopulmonary dysfunction

Primary outcomes:
measure: Brain Activation Pattern Caused by Immersive Virtual Reality Pathfinding Task in Stroke Patients
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Department of Rehabilitation Medicine, the First Affiliated Hospital of Chongqing Medical University, Chongqing,, Chongqing, Chongqing 400010
state: Chongqing
Study officials:
References: