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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorFujian University of Traditional Chinese Medicine

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial 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.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • 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.

Treatment groups

72 Participants
are divided into 3 treatment groups
Group A: Dysphagia in the oral phase after stroke1 intervention
Group B: Without dysphagia after stroke1 intervention
Group C: Healthy controls1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Before fMRI scan
2

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

Time frame
Baseline

Secondary outcomes

1

Functional Oral Intake Scale (FOIS)

The Functional Oral Intake Scale (FOIS) is a reliable and valid tool for assessing functional oral food and fluid intake in patients with oropharyngeal dysphagia (OD). Fois has seven levels, with higher levels indicating better swallowing function.

Time frame
Baseline

Other outcomes

1

Videofluoroscopicdysphagia scale(VDS)

The VDS scale should be evaluated by videofluoroscopic swallowing study. The VDS has a total of 14 items, including 2 dimensions (oral phase and phase). Scores range from 0 to 100, with higher scores indicating greater severity of dysphagia.

Time frame
Baseline
2

Water Swallowing Test (WST)

Water Swallow Test (WST) is a method to evaluate the swallowing function of patients by observing their swallowing movements and performance during drinking water.

Time frame
Baseline

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fujian University of Traditional Chinese Medicine

Lead sponsor

Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science

Collaborator

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