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Clinical Trials/NCT06208020
NCT06208020
Recruiting
N/A

Cortical Activation and Functional Connectivity Changes During Swallowing in Patients With Dysphagia in Lateral Medullary Syndrome

The First Affiliated Hospital of Zhengzhou University1 site in 1 country20 target enrollmentMay 31, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Deglutition Disorders
Sponsor
The First Affiliated Hospital of Zhengzhou University
Enrollment
20
Locations
1
Primary Endpoint
cortical activation during swallowing
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The goal of this observational study is to detect the alteration of cortical activation and functional connectivity during swallowing in patients with Lateral Medullary Syndrome (LMS) dysphagia by functional near infrared spectroscopy (fNIRS). The main questions it aims to answer are:

  • The alteration of cortical activation during swallowing in patients with LMS compared with healthy subjects.
  • The alteration of cortical functional connectivity during swallowing in patients with LMS compared with healthy subjects.

fNIRS will be used to detect cortical activation and functional connectivity during swallowing tasks in LMS patients and healthy subjects, and to compare the differences between patients and healthy subjects.

Registry
clinicaltrials.gov
Start Date
May 31, 2023
End Date
February 15, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
The First Affiliated Hospital of Zhengzhou University
Responsible Party
Principal Investigator
Principal Investigator

Li Yi

Principal Investigator

The First Affiliated Hospital of Zhengzhou University

Eligibility Criteria

Inclusion Criteria

  • The first ischemic stroke was confirmed by head MRI as LMS;
  • 18-80 years old, right-handed;
  • Dysphagia was confirmed by video fluoroscopic swallow study(VFSS);
  • Conscious enough to cooperate with fNIRS testing;
  • No previous neurological or mental illness.

Exclusion Criteria

  • Other central nervous system diseases (Parkinson's disease, Alzheimer's disease, intracranial tumors, etc.);
  • Other diseases causing dysphagia (tumors of the esophagus, larynx, nasopharynx, etc.);
  • Serious physical diseases (cancer, fracture, etc.);
  • Other mental disorders (mania, schizophrenia, etc.);
  • Unconscious, unable to cooperate with the examination

Outcomes

Primary Outcomes

cortical activation during swallowing

Time Frame: day 1

The NirSpark package will be used to preprocess and analyze the fNIRS data. The steps will be used to preprocess the data including: deleting irrelevant time intervals and unrelated artifacts; turning the intensity of light into optical density; choosing the band-pass filter to filter the noise and interference signals (0.01-0.2 Hz); translating optical density to the oxygen concentration in the blood; and setting the initial time of the hemodynamic response function (HRF) to 30 s and the end time to 60 s (the time for a single block paradigm). To analyze the HbO2 time-series data, a generalized linear model (GLM) will be used. The GLM could calculate the degree of matching between the experimental and ideal HRF values for each task and participant. The beta value, which represents the channel's level of cortical activation, will be utilized to estimate the HRF prediction of the HbO2 signal and can be used to represent the HRF function's peak value.

Secondary Outcomes

  • functional connectivity during swallowing(day 1)

Study Sites (1)

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