An fNIRS Study of Motor Cortical Activation in Stoke Patients

NCT ID: NCT05376098

Last Updated: 2022-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-01

Study Completion Date

2024-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The investigators evaluate the activation and connectivity of patients' motor regions in the acute phase of ischemic stroke by fNIRS.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study aims to analyze the progress of brain recovery from upper-limb deficit due to acute ischemic stroke, using Functional Near-infrared Spectroscopy(fNIRS) as the main neural imaging method. Fifty patients having experienced a stroke onset within seven days will be recruited from the emergency room. The fNIRS signals will be recorded bilaterally over the contralateral sensorimotor cortex, the premotor area, the supplementary motor area, the primary motor cortex for 14 days after being diagnosed. Then compute activation and connectivity of the regions. The motor function data measured by the assessment scales, as well as the behavioral record during the fNIRS motor tasks will be collected as well.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Ischemic Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* The diagnosis of ischemic stroke should meet the diagnostic criteria of the "China Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018".
* 18 years old≤ age ≤ 75 years old.
* Cerebral ischemic stroke onset within 7 days.
* First onset.
* Upper limb motor dysfunction.

Exclusion Criteria

* Unstable vital signs.
* Complicated with other diseases in the nervous system.
* Combined with other serious disease states: circulatory system, respiratory system,
* motor system diseases, such as atrial fibrillation, heart failure, lung infection, severe liver and kidney dysfunction, lower limb venous thrombosis, etc.
* Upper limb dysfunction caused by other reasons, such as fractures, upper limb deformities, etc.
* Contraindicated to imaging tests, such as metal implantation, claustrophobia, and severe obesity.
* Those who cannot complete the examination due to other reasons, such as mental disorders, cognitive dysfunction, etc.
* Other causes: alcoholism; pregnancy; skull defects; soft tissue injuries at the site of examination; visual impairment, etc.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Xuanwu Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Junwei Hao

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Xuanwu Hospital, Capital Medical University

Beijing, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Junwei Hao

Role: CONTACT

010-83199088

haijie Liu

Role: CONTACT

+86 15822841534

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Junwei Hao, M.D.,Ph.D

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

haojunwei7

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.