An fNIRS Study of Motor Cortical Activation in Stoke Patients

• Conditions: Acute Ischemic Stroke

• Registration Number: NCT05376098
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2021-12
• Study Start: 2022-02-01
• Study First Submitted: 2022-04-01
• Study First Submitted QC: 2022-05-15
• Last Update Submitted: 2022-05-15
• Study First Posted: 2022-05-17
• Last Update Posted: 2022-05-17
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
fNIRS characteristics of upper limb movement	0-14 day	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.
Assessment of upper limb function	0-14 day	Evaluating the motor function by Fugl-meyer assessment.

Trial Locations

Locations (1)

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, China