StrokeNCT06703307
Biomarkers Related to PSCI: An fNIRS Study
An observational study of Stroke and Cognitive Decline, run by Dingqun Bai at 1 site in China.
Trial summary
This is an fNIRS study performed to identify biomarkers related to post-stroke cognitive impairment. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Cognitive Decline
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 30 Apr 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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:
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Rehabilitation Medicine, the First Affiliated Hospital of Chongqing Medical University, Chongqing,
Chongqing, Chongqing Municipality, 400010
Defei Chen, +8615188017034, 2283273437@qq.com
About this study
Official title: Identifying Biomarkers Related to Post-stroke Cognitive Impairment: A fNIRS Study
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.
- Conditions
- Stroke, Cognitive Decline
- Keywords
- stroke, post-stroke cognitive impairment, fNIRS
- Medical subject headings
- Stroke, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start1 Aug 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dingqun Bai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dingqun Bai, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703307
- Sponsor's protocol ID
- 20241121
- Status last verified
- Nov 2024
- First submitted
- 21 Nov 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Biomarkers Related to Post-stroke Cognitive Impairment: A fNIRS Study
- ClinicalTrials.gov ID
- NCT06703307
- Acronym / sponsor ID
- 20241121
- Conditions
- Stroke, Cognitive Decline
- Keywords
- stroke, post-stroke cognitive impairment, fNIRS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dingqun BaiUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 25 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
- Inability to tolerate the test due to organic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Cognitive Decline, run by Dingqun Bai at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dingqun Bai (023-89011334, baidingqun@hospital.cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preliminary screening of brain function biomarkers for post-stroke cognitive impairment (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.