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

NCT06208020 | Unknown

• 1 other identifier: LMS dysphagia
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Deglutition Disorders; Lateral Medullary Syndrome

Outcome Measures

Primary Outcomes (1)

• cortical activation during swallowing

  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.

  day 1

Secondary Outcomes (1)

• functional connectivity during swallowing

  day 1

Study Arms (2)

LMS patients

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.

Other: Functional near-infrared spectroscopy (fNIRS) detection

healthy subjects

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.

Other: Functional near-infrared spectroscopy (fNIRS) detection

Interventions

Functional near-infrared spectroscopy (fNIRS) detection OTHER

fNIRS( NirScan Danyang Huichuang Medical Equipment Co. Ltd., China) will be used to detect changes in HbO and HbR during rest and voluntary swallowing. The swallowing procedure will be used consisted of three phases of manipulations: 30-s resting state periods, 30-s swallowing periods and 30-s resting state periods. A pre-collection will be conducted before the formal collection so that the subjects could understand the test process. After the pre-collection, the subjects will take a rest for 5 minutes before the formal collection.

LMS patients; healthy subjects

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with dysphagia in LMS and healthy adults will be enrolled.

You may qualify if:

• The first ischemic stroke was confirmed by head MRI as LMS;
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450001, China

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders; Lateral Medullary Syndrome

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Brain Stem Infarctions; Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Yi Li

  The First Affiliated Hospital of Zhengzhou University

  STUDY CHAIR

Central Study Contacts

Yi Li, Master

CONTACT

+8618810838848; muziyi3696085@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 17, 2024
• Study Start: May 31, 2023
• Primary Completion: January 31, 2024
• Study Completion: February 15, 2024
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)