NCT06703307

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 25, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

November 26, 2024

Status Verified

November 1, 2024

Enrollment Period

8 months

First QC Date

November 21, 2024

Last Update Submit

November 24, 2024

Conditions

Keywords

strokepost-stroke cognitive impairmentfNIRS

Outcome Measures

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

    1 day

Study Arms (3)

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.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Stroke patients:
  • Diagnosis of stroke confirmed by neuroimaging (CT or MRI)
  • 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
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Chongqing, Chongqing Municipality, 400010, China

RECRUITING

MeSH Terms

Conditions

StrokeCognitive Dysfunction

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of rehabilitation Medicine

Study Record Dates

First Submitted

November 21, 2024

First Posted

November 25, 2024

Study Start

August 1, 2024

Primary Completion

April 1, 2025

Study Completion

April 30, 2025

Last Updated

November 26, 2024

Record last verified: 2024-11

Locations