Clinical trial NCT05376098: An fNIRS Study of Motor Cortical Activation in Stoke Patients
Official title: A Temporal Study of Brain Motor Regions of Acute Ischemic Stroke Based on fNIRS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Ischemic Stroke
Keywords: Stroke
Motor rehabilitation
Brain regions
fNIRS
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2022-05-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute ischemic stroke with upper limb motor dysfunction diagnosed and treated by the Xuanwu Hospital Capital Medical University.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: fNIRS characteristics of upper limb movement
timeFrame: 0-14 day
measure: Assessment of upper limb function
timeFrame: 0-14 day
measure: Assessment of upper limb function
timeFrame: 0-14 day
measure: Assessment of upper limb function
timeFrame: 0-14 day
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Junwei Hao
role: PRINCIPAL_INVESTIGATOR
References: