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

NCT ID: NCT06208020

Last Updated: 2024-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-31

Study Completion Date

2024-02-15

Brief Summary

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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

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Conditions

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Deglutition Disorders Lateral Medullary Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Functional near-infrared spectroscopy (fNIRS) detection

Intervention Type 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.

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.

Functional near-infrared spectroscopy (fNIRS) detection

Intervention Type 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.

Interventions

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Functional near-infrared spectroscopy (fNIRS) detection

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role lead

Responsible Party

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Li Yi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yi Li

Role: STUDY_CHAIR

The First Affiliated Hospital of Zhengzhou University

Locations

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The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yi Li, Master

Role: CONTACT

+8618810838848

Facility Contacts

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Yi Li

Role: primary

+8618810838848

Other Identifiers

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LMS dysphagia

Identifier Type: -

Identifier Source: org_study_id

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