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NCT Number: NCT06564688

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

Swallowing is a complex movement consisting of sequential and ordered activation of swallowing muscles interconnected cortical areas that facilitate the complex communication of sensory inputs and motor outputs to control oral movements such as jaw or chewing.During the swallowing task, the cortical swallowing network collaborates with each other to regulate swallowing activity. The damage of the swallowing cortex can affect the coordination of muscle groups in the swallowing process. Compared with healthy people, stroke patients show disordered swallowing movements, which greatly increases the risk of aspiration. Different lesions and connectivity patterns of stroke can affect the prognosis of dysphagia after stroke.In stroke patients with dysphagia, functional brain networks associated with motor control of swallowing were found to be disrupted in acute stroke patients with dysphagia.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.The purpose of this study is to explore the specific brain regions that are related to the dynamic changes of the functional connectivity pattern of the cortical swallowing network and the neuroimaging representations of the interbrain interaction in the oral phase of patients with dysphagia after stroke.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inclusion criteria of patients with post-stroke oral dysphagia:
  • 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.
  • Inclusion criteria of patients without dysphagia after stroke:
  • 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.
  • Inclusion criteria of healthy control group:
  • Normal cognitive function and swallowing function, FOIS level =7; WST level =1;
  • Gender and age matched with patients with dysphagia in the oral phase after stroke;
  • Right-handed;
  • Voluntary participants with informed consent.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Standard Swallowing Assessment (SSA)

    Time frame: Before fMRI scan

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

  2. Oral Functional Scale

    Time frame: Baseline

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

Secondary outcomes

  1. Functional Oral Intake Scale (FOIS)

    Time frame: Baseline

    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.

Other outcomes

  1. Videofluoroscopicdysphagia scale(VDS)

    Time frame: Baseline

    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.

  2. Water Swallowing Test (WST)

    Time frame: Baseline

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

Study contacts

Contact information is provided by the study sponsor or research team.

Qingqing Zhang

CONTACT

[email protected]

18150019719

Sponsors and collaborators

Lead sponsor

Fujian University of Traditional Chinese Medicine

Other

Collaborators

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

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 21, 2024
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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