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Status unknownNCT05376098Updated May 17, 2022

An fNIRS Study of Motor Cortical Activation in Stoke Patients

An observational study in Acute Ischemic Stroke, sponsored by Xuanwu Hospital, Beijing. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-05-17.

Sponsored by Xuanwu Hospital, Beijing · Observational

The sponsor has not verified this record recently (last verified Dec 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Acute Ischemic Stroke

Keywords

  • Stroke
  • Motor rehabilitation
  • Brain regions
  • fNIRS
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 50 is below the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Xuanwu Hospital, Beijing is the lead sponsor of 346 studies on the registry; 217 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 0-14 day

  2. Assessment of upper limb function

    Recording the quality and frequency of fNIRS motion tasks including grip and reach-out movements.

    Time frame: 0-14 day

  3. Assessment of upper limb function

    Evaluating the motor function by Action Research Arm Test.

    Time frame: 0-14 day

  4. Assessment of upper limb function

    Evaluating the motor function by Fugl-meyer assessment.

    Time frame: 0-14 day

07

Study locations

1 of 1 sites recruiting
  • Xuanwu Hospital, Capital Medical University
    Beijing, China
    • Junwei Hao, M.D.,Ph.D · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05376098
Lead sponsor
Xuanwu Hospital, Beijing
Responsible party
Sponsor
First posted
May 17, 2022
Start date
Feb 1, 2022
Primary completion
Jul 1, 2024 (estimated)
Completion
Jul 31, 2024 (estimated)
Last update
May 17, 2022

Study contacts

Junwei Hao
Contact
haojunwei@vip.163.com
010-83199088
haijie Liu
Contact
haijieliu@163.com
+86 15822841534
Junwei Hao
principal investigator · Xuanwu Hospital, Beijing

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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