To Explore the Functional Connectivity Pattern of Cortical Swallowing Network in the Oral Phase of Post-stroke Dysphagia Based on Dynamic Causal Modelling

NCT06564688 | Not Yet Recruiting

• 1 other identifier: 2023KY-015-02
• Study Type: observational
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

Swallowing activity in the oral phase is regulated by the cortical swallowing network, and the functional connectivity pattern of the cortical swallowing network is related to swallowing activity. The structural damage of the cortical swallowing network and abnormal activation of brain areas related to swallowing in post-stroke dysphagia affect swallowing activity. The recovery of dysphagia after stroke is related to the compensation of swallowing network in the contralateral hemisphere and different connectivity patterns of diseased brain areas, and the integrity of cortical swallowing network connectivity affects the sequence of oral swallowing activities. However, it is not clear how the functional connectivity patterns and interactions of brain regions of the cortical swallowing network related to oral swallowing activity change in patients with oral dysphagia after stroke.

Conditions

Dysphagia After Stroke; Cortical Swallowing Network; Functional Magnetic Resonance Imaging; Oral Phase; Dynamic Causal Modelling

Outcome Measures

Primary Outcomes (2)

• Standard Swallowing Assessment (SSA)

  The scale has a minimum score of 18 and a maximum score of 46, with higher scores indicating poorer swallowing function

  Before fMRI scan

• Oral Functional Scale

  The Oral Functional Scale is a tool used to assess the oral functional status of an individual, with higher scores indicating better oral function

  Baseline

Secondary Outcomes (1)

• Functional Oral Intake Scale (FOIS)

  Baseline

Other Outcomes (2)

• Videofluoroscopicdysphagia scale（VDS）

  Baseline

• Water Swallowing Test (WST)

  Baseline

Study Arms (3)

Dysphagia in the oral phase after stroke

The swallowing function was assessed by swallowing related scale and the Videofluoroscopic Swallowing Study, and then functional magnetic resonance imaging was performed.

Diagnostic Test: Swallowing function test

Without dysphagia after stroke

First, the swallowing function related scale was evaluated, and then the functional magnetic resonance imaging (fMRI) scan was performed.

Diagnostic Test: Swallowing function test

Healthy controls

First, the swallowing function related scale was evaluated, and then the functional magnetic resonance imaging (fMRI) scan was performed.

Diagnostic Test: Swallowing function test

Interventions

Swallowing function test DIAGNOSTIC_TEST

The oral function score assesses the oral functional performance of chewing in all participants. The Functional oral feeding Scale (FOIS) was used to assess the ability of all participants to eat. The standardized swallowing assessment (SSA) was used to assess the global swallowing function of all participants.

Dysphagia in the oral phase after stroke; Healthy controls; Without dysphagia after stroke

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

Three categories of population were included in this study: post-stroke dysphagia in the oral phase, post-stroke dysphagia without dysphagia, and healthy controls. The subjects with post-stroke dysphagia were mainly those with oral dysphagia caused by the first stroke, who were able to complete the assessment and scanning, and had no contraindications to MRI scanning. The course of post-stroke dysphagia was between 0 and 6 months. The subjects without dysphagia after stroke were free of swallowing dysfunction after first stroke, could complete the assessment and scan, the course of stroke was between 0 and 6 months, and there were no contraindications to MRI scanning. The healthy controls were healthy people with normal cognition, swallowing function, and no contraindications to MRI scanning.

You may qualify if:

• Patients with dysphagia after first stroke, meeting the diagnostic criteria of stroke, and confirmed by brain CT or brain MRI;
• Oral dysphagia caused by stroke;
• FOIS level ≤ 5; WST level ≥3;
• Those who can understand and carry out the simple instructions of the treatment staff and are willing to accept the examination and treatment;
• Clear consciousness and stable vital signs;
• Patients in the recovery stage with stroke course and dysphagia duration between 0 and 6 months;
• Right-handed;
• Voluntary participants with informed consent.
• Patients with first-ever stroke, meeting the diagnostic criteria of stroke, and confirmed by brain CT or brain MRI;
• No dysphagia, FOIS level =7; WST level =1;
• Those who can understand and carry out the simple instructions of the treatment staff and are willing to accept the examination and treatment;
• Clear consciousness and stable vital signs;
• Patients in the recovery stage with stroke duration between 0 and 6 months;
• Right-handed;
• Voluntary participants with informed consent.

You may not qualify if:

• Dysphagia not caused by stroke or non-oral dysphagia;
• History of cerebral trauma, stroke, brain tumor, cerebrovascular, intracranial infection, Parkinson's disease, epilepsy, or other neurological or psychiatric diseases;
• Symptoms of severe aphasia, neglect, visual field defect and other cortical lesions; Patients with severe cognitive impairment or depression;
• Taking or within 2 weeks of taking drugs that affect the nervous system or psychoses;
• Patients with metal implants and/or spatial claustrophobia who are not suitable for MRI scanning;
• Visual/hearing disorders affecting training and assessment;
• Persons who are participating in other research trials that may influence the results of this study.

Sponsors & Collaborators

• Fujian University of Traditional Chinese Medicine: lead
• Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science: collaborator

Central Study Contacts

Qingqing Zhang

CONTACT

18150019719; 2017013@fjtcm.edu.cn

Study Design

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

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 21, 2024
• Study Start: August 20, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share