CClinicalTrials.gg
RecruitingNCT06703307Updated Nov 26, 2024

Biomarkers Related to PSCI: An fNIRS Study

An observational study in Stroke and Cognitive Decline, sponsored by Dingqun Bai. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-26.

Sponsored by Dingqun Bai · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 6 months ago, but the record still lists the study as recruiting.
  • Started Aug 2024; still recruiting 2 years 2 months later.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
60
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Stroke
  • Cognitive Decline

Keywords

  • stroke
  • post-stroke cognitive impairment
  • fNIRS
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's planned enrollment of 60 is below the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Dingqun Bai is the lead sponsor of 4 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

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
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • Healthy subjects

    Healthy subjects without history of stroke or cognitive impairment.

  • PSCI

    Stroke patients with post-stroke cognitive impairment.

  • NPSCI

    Stroke patients without post-stroke cognitive impairment.

06

What researchers measure

Primary outcomes

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

    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

    Time frame: 1 day

07

Study locations

1 of 1 sites recruiting
  • Department of Rehabilitation Medicine, the First Affiliated Hospital of Chongqing Medical University, Chongqing,
    Chongqing, Chongqing 400010, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06703307
Lead sponsor
Dingqun Bai
Responsible party
Dingqun Bai (Director of rehabilitation Medicine, First Affiliated Hospital of Chongqing Medical University) — Sponsor-investigator
First posted
Nov 25, 2024
Start date
Aug 1, 2024
Primary completion
Apr 1, 2025 (estimated)
Completion
Apr 30, 2025 (estimated)
Last update
Nov 26, 2024

Study contacts

Dingqun Bai
Contact
baidingqun@hospital.cqmu.edu.cn
023-89011334
Defei Chen
Contact
2283273437@qq.com
+8615188017034

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion