Biomarkers Related to PSCI: An fNIRS Study

Recruiting

• Conditions: Stroke; Cognitive Decline

• Registration Number: NCT06703307
• Lead Sponsor: Dingqun Bai

Brief Summary

This is an fNIRS study performed to identify biomarkers related to post-stroke cognitive impairment.

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 the cognitive task (Stroop task, 1-back task and verbal fluency test) 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. Biomarkers related to post-stroke cognitive impairment will be identified by by comparing differences in brain activation and brain network connectivity between patients and healthy subjects.

Study Timeline

• Study Start: 2024-08-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-21
• Study First Submitted QC: 2024-11-21
• Last Update Submitted: 2024-11-24
• Study First Posted: 2024-11-25
• Last Update Posted: 2024-11-26
• Primary Completion: 2025-04-01
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Preliminary screening of brain function biomarkers for post-stroke cognitive impairment	1 day	Comparison of differences in brain activation \[HbO2 (mmol/L\*mm)\] between patients with post-stroke cognitive impairment and patients without post-stroke cognitive impairment or healthy subjects

Trial Locations

Locations (1)

Department of Rehabilitation Medicine, the First Affiliated Hospital of Chongqing Medical University, Chongqing,; 🇨🇳 Chongqing, Chongqing, China