Functional Response Characteristics of Brain Under Swallowing Task Paradigm

Dysphagia Clinical Trial

Official title:

Functional Response Characteristics of Brain Under Swallowing Task Paradigm Based on Functional Near-infrared Spectroscopy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06411236
• Other study ID #: 2020-PT310-04
• Status: Not yet recruiting
• Start date: May 10, 2024
• Est. completion date: December 10, 2024

Study information

• Verified date: May 2024
• Source: The First Affiliated Hospital of Zhengzhou University
• Contact: Ruyao Liu
• Phone: +8615617749628
• Email: rio1274287008[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Functional near-infrared spectroscopy was used to investigate the cortical activation patterns and lateralization during swallowing tasks in 15 healthy middle-aged and elderly people and 15 healthy young people. It provides a theoretical basis for the study of swallowing function and a new idea for the treatment of patients with swallowing disorders.

Description:

Swallowing is coordinated by hyoid muscle group, pharyngeal muscle and upper esophageal muscle, as well as the regulation of swallowing related functional brain area. Dysphagia refers to the inability to safely and effectively transport food from the mouth to the stomach to obtain adequate nutrition and water, resulting in eating difficulties. Studies have shown that swallowing disorders are mainly caused by stroke, brain trauma, neurodegenerative diseases (Alzheimer's disease, Parkinson's disease, multiple sclerosis and amyotrophic lateral sclerosis) and head and neck cancers (oral tumors, nasopharyngeal and laryngeal cancers). Moreover, the prevalence of dysphagia increases with age. Patients with dysphagia often have many complications, which may lead to dehydration, malnutrition, aspiration, pneumonia, etc., which greatly delays the recovery process of patients and reduces the quality of life of patients. Studies have shown that the swallowing network includes multiple brain regions, including the primary somatosensory cortex, primary motor cortex, bilateral premotor and auxiliary motor cortex, cingulate cortex, prefrontal, temporal, precuneus, subparietal lobule, cerebellum and cerebellum.

At present, there are some functional near-infrared spectroscopy studies on the swallowing function of healthy people, which mainly focus on healthy young subjects, and studies show that the incidence of swallowing disorders increases with age, the incidence of swallowing disorders in people over 50 years old is 5.5% ~ 8%, and swallowing disorders are mainly concentrated in middle-aged and elderly people. At present, there are no studies on swallowing function in middle-aged and elderly healthy subjects with functional near-infrared spectroscopy. The purpose of this study is to explore and compare the cortical activation patterns and lateralization in the swallowing task of healthy middle-aged and elderly people and young people by using functional near-infrared spectroscopy, providing a theoretical basis for the exploration of swallowing function and further providing new ideas for the treatment of patients with swallowing disorders.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 10, 2024
• Est. primary completion date: November 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

Middle and old age group: 50~70 years old; Young group: 18~25 years old; Right-handed; No history of neurological, psychiatric, respiratory, or swallowing dysfunction; No brain injury, epilepsy, head and neck disease, gastroesophageal reflux disease; No cases of skull defect, head infection and skin damage that could not be detected by function near-infrared spectroscopy; Subjects signed informed consent forms in accordance with the Declaration of Helsinki.

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Exclusion Criteria:

pregnancy; poor patient compliance and non-cooperation with evaluation.

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Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Swallowing Disorder

Locations

Country	Name	City	State
China	The first affiliated hospital of zhengzhou university	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Ruyao Liu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional near-infrared spectroscopy	Resting state detection: After entering the NIR assessment room, the subjects sat comfortably for 5 minutes, and then wore fNIRS headcaps. The subjects were asked to sit quietly and avoid moving and thinking for 30 seconds.; Task state detection: Subjects entered the NIR assessment room, sat comfortably for 5 minutes, and then wore fNIRS headcaps. After resting for 30 seconds, the subjects were asked to swallow, swallow saliva for 20 seconds, rest for 20 seconds, and repeat three times.	day 1