Functional Response Characteristics of Brain Under Swallowing Task Paradigm

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dysphagia; Swallowing Disorder; Swallowing Substances

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Ruyao Liu; Phone Number: +8615617749628; Email: rio1274287008@163.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450000
      • The First Affiliated Hospital of Zhengzhou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

People aged 18-25 who met the inclusion exclusion criteria were included in the younger group. People aged 50-70 who met the exclusion criteria were included in the Middle aged group.Subjects need to understand the swallowing task and cooperate well.

Description

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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Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
middle and old group; A total of 15 middle-aged and elderly subjects were selected. 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.
young group; A total of 15 young subjects were selected. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ruyao Liu
• Investigators: Study Chair: Xi Zeng, The First Affiliated Hospital of Zhengzhou University

Study record dates

Study Major Dates

• Study Start (Estimated): May 10, 2024
• Primary Completion (Estimated): November 10, 2024
• Study Completion (Estimated): December 10, 2024

Study Registration Dates

• First Submitted: May 8, 2024
• First Submitted That Met QC Criteria: May 8, 2024
• First Posted (Actual): May 13, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: 2020-PT310-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The datasets generated and analyzed during the current study are not publicly available due to the hospital's confidentiality regulations regarding trial data but are available from the corresponding author on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No