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NCT Number: NCT06703307

Biomarkers Related to PSCI: An fNIRS Study

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

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Chongqing, Chongqing Municipality, 400010, China

Location status: Recruiting

Location contact

Defei Chen

CONTACT

[email protected]

+8615188017034

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Stroke patients:

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

Healthy Subjects:

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

Exclusion criteria

Stroke patients:

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

Healthy Subjects:

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

Treatment and study plan

Primary outcomes

  1. Preliminary screening of brain function biomarkers for post-stroke cognitive impairment

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Defei Chen

CONTACT

[email protected]

+8615188017034

Dingqun Bai

CONTACT

[email protected]

023-89011334

Sponsors and collaborators

Lead sponsor

Dingqun Bai

Other

Registry information

Official study title

Identifying Biomarkers Related to Post-stroke Cognitive Impairment: A fNIRS Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 25, 2024
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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