Biomarkers Related to PSCI: An fNIRS Study

Last updated: November 24, 2024
Sponsor: Dingqun Bai
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Memory Problems

Memory Loss

Treatment

N/A

Clinical Study ID

NCT06703307
20241121
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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

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 thetrial

  3. Pregnant or lactating women

  4. Had metal implants, a history of other neurological disorders, acute cardiopulmonarydysfunction.

Healthy Subjects:

  1. Inability to tolerate the test due to organic diseases

  2. Serious mental illness that prevents them from cooperating with or tolerating thetrial.

  3. Pregnant or lactating women

  4. Had metal implants, a history of other neurological disorders, acute cardiopulmonarydysfunction

Study Design

Total Participants: 60
Study Start date:
August 01, 2024
Estimated Completion Date:
April 30, 2025

Study 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.

Connect with a study center

  • Department of Rehabilitation Medicine, the First Affiliated Hospital of Chongqing Medical University, Chongqing,

    Chongqing, Chongqing 400010
    China

    Active - Recruiting

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