Dysphagia After StrokeNCT06564688
To Explore the Functional Connectivity Pattern of Cortical Swallowing Network in the Oral Phase of Post-stroke Dysphagia Based on Dynamic Causal Modelling
An observational study of Dysphagia After Stroke and Cortical Swallowing Network, run by Fujian University of Traditional Chinese Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysphagia After Stroke, Cortical Swallowing Network, Functional Magnetic Resonance Imaging
- What is being tested?
- Swallowing function test
- Type of treatment
- Pill or oral medicine
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2024to 1 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed description
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.
- Conditions
- Dysphagia After Stroke, Cortical Swallowing Network, Functional Magnetic Resonance Imaging, Oral Phase, Dynamic Causal Modelling
- Being tested
- Swallowing function test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swallowing function testDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: Swallowing function test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start20 Aug 2024 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysphagia After StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science
- Responsible party
- Principal investigator, Qingqing Zhang, Fujian University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564688
- Sponsor's protocol ID
- 2023KY-015-02
- Status last verified
- Aug 2024
- First submitted
- 12 Aug 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Explore the Functional Connectivity Pattern of Cortical Swallowing Network in the Oral Phase of Post-stroke Dysphagia Based on Dynamic Causal Modelling
- ClinicalTrials.gov ID
- NCT06564688
- Acronym / sponsor ID
- 2023KY-015-02
- Conditions
- Dysphagia After Stroke, Cortical Swallowing Network, Functional Magnetic Resonance Imaging, Oral Phase, Dynamic Causal Modelling
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Fujian University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science
- Study start
- 20 Aug 2024 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dysphagia in the oral phase after stroke | – | Diagnostic Test: Swallowing function testThe swallowing function was assessed by swallowing related scale and the Videofluoroscopic Swallowing Study, and then functional magnetic resonance imaging was performed. |
| Without dysphagia after stroke | – | Diagnostic Test: Swallowing function testFirst, the swallowing function related scale was evaluated, and then the functional magnetic resonance imaging (fMRI) scan was performed. |
| Healthy controls | – | Diagnostic Test: Swallowing function testFirst, the swallowing function related scale was evaluated, and then the functional magnetic resonance imaging (fMRI) scan was performed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (22 listed)
- Inclusion criteria of patients with post-stroke oral dysphagia:
- Inclusion criteria of patients without dysphagia after stroke:
- Inclusion criteria of healthy control group:
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Swallowing function testThe 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. | Diagnostic test | Dysphagia in the oral phase after stroke, Healthy controls, Without dysphagia after stroke |
Primary outcome
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
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
1 secondary outcome
Functional Oral Intake Scale (FOIS)
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysphagia After Stroke and Cortical Swallowing Network, run by Fujian University of Traditional Chinese Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qingqing Zhang (18150019719, 2017013@fjtcm.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard Swallowing Assessment (SSA) (time frame: Before fMRI scan). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.