An fNIRS Study of Motor Cortical Activation in Stoke Patients

Acute Ischemic Stroke Clinical Trial

Official title:

A Temporal Study of Brain Motor Regions of Acute Ischemic Stroke Based on fNIRS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05376098
• Other study ID #: haojunwei7
• Status: Recruiting
• Start date: February 1, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: December 2021
• Source: Xuanwu Hospital, Beijing
• Contact: Junwei Hao
• Phone: 010-83199088
• Email: haojunwei[@]vip.163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 31, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fNIRS characteristics of upper limb movement	The changes in brain oxygen levels are collected in two wavelengths, including 845 and 763 nanometers using a 44 channeled fNIRS machine. The data is used to determine the position of the activated area of the brain and functional connectivity during the movement. The locations of fNIRS channels on the skull of individuals are determined due to the observations on the cortical regions of interest (ROIs), namely the contralateral sensorimotor cortex (SMC), the contralateral premotor cortex (PMC) and primary motor cortex (M1), etc.	0-14 day
Primary	Assessment of upper limb function	Recording the quality and frequency of fNIRS motion tasks including grip and reach-out movements.	0-14 day
Primary	Assessment of upper limb function	Evaluating the motor function by Action Research Arm Test.	0-14 day
Primary	Assessment of upper limb function	Evaluating the motor function by Fugl-meyer assessment.	0-14 day