Biomarkers Related to PSCI: An fNIRS Study | NCT06703307

Studies
Biomarkers Related to PSCI: An fNIRS Study

NCT06703307

Sponsor

Dingqun Bai

Status

Recruiting

Last Update Posted

Nov 26, 2024Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Stroke
Cognitive Decline

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2024Actual

Primary Completion Date

Apr 1, 2025Estimated

Completion Date

Apr 30, 2025Estimated

First Submitted Date

Nov 21, 2024

First Submission Date that Met QC Criteria

Nov 21, 2024

First Posted Date

Nov 25, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 24, 2024

Last Update Posted Date

Nov 26, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

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

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Rehabilitation Medicine, the First Affiliated Hospital of Chongqing Medical University, Chongqing,	Recruiting	Chongqing	Chongqing Municipality	400010	China

ID	Term
D020521	Stroke
D060825	Cognitive Dysfunction

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases