Cortical Function Changes During Swallowing in Patients With Dysphagia in Lateral Medullary Syndrome

Recruiting

• Conditions: Deglutition Disorders; Lateral Medullary Syndrome
• Interventions: Other: Functional near-infrared spectroscopy (fNIRS) detection

• Registration Number: NCT06208020
• Lead Sponsor: The First Affiliated Hospital of Zhengzhou University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-31
• Status Verified: 2024-01
• Study First Submitted: 2024-01-05
• Study First Submitted QC: 2024-01-05
• Study First Posted: 2024-01-17
• Last Update Submitted: 2024-01-17
• Last Update Posted: 2024-01-19
• Primary Completion: 2024-01-31
• Study Completion: 2024-02-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
healthy subjects	Functional near-infrared spectroscopy (fNIRS) detection	The demographic characteristics will be collected, including sex and age. fNIRS will be used to detect changes in oxyhemoglobin (HbO) and deoxyhemoglobin (HbR) during rest and voluntary swallowing.
LMS patients	Functional near-infrared spectroscopy (fNIRS) detection	The demographic characteristics will be collected, including sex, age, stroke duration, and lesion side; Penetration-aspiration (PAS) scale will be used to evaluate swallowing function. fNIRS will be used to detect changes in oxyhemoglobin (HbO) and deoxyhemoglobin (HbR) during rest and voluntary swallowing.

Primary Outcome Measures

Name	Time	Method
cortical activation during swallowing	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 Outcome Measures

Name	Time	Method
functional connectivity during swallowing	day 1	The Network module of NirSpark software was used to extract the HbO2 concentration change at each time point, analyze the Pearson correlation coefficient of HbO2 concentration in each channel on the time series, and define it as the functional connection strength between channels through Fisher-Z conversion.; The Network module of NirSpark software was used to extract the HbO2 concentration change at each time point, analyze the Pearson correlation coefficient of HbO2 concentration in each channel on the time series, and define it as the functional connection strength between channels through Fisher-Z conversion.; The Network module of NirSpark software was used to extract the HbO2 concentration change at each time point, analyze the Pearson correlation coefficient of HbO2 concentration in each channel on the time series, and define it as the functional connection strength between channels through Fisher-Z conversion.

Trial Locations

Locations (1)

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China