Deglutition DisordersNCT06208020
Cortical Function Changes During Swallowing in Patients With Dysphagia in Lateral Medullary Syndrome
An observational study of Deglutition Disorders and Lateral Medullary Syndrome, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial summary
The goal of this observational study is to detect the alteration of cortical activation and functional connectivity during swallowing in patients with Lateral Medullary Syndrome (LMS) dysphagia by functional near infrared spectroscopy (fNIRS). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Deglutition Disorders, Lateral Medullary Syndrome
- What is being tested?
- Functional near-infrared spectroscopy (fNIRS) detection
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2023to 15 Feb 2024
- 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: Patients with dysphagia in LMS and healthy adults will be enrolled.
Who may be able to join
- The first ischemic stroke was confirmed by head MRI as LMS;
- 18-80 years old, right-handed;
- Dysphagia was confirmed by video fluoroscopic swallow study(VFSS);
- Conscious enough to cooperate with fNIRS testing;
- No previous neurological or mental illness.
Who cannot join
- Other central nervous system diseases (Parkinson's disease, Alzheimer's disease, intracranial tumors, etc.);
- Other diseases causing dysphagia (tumors of the esophagus, larynx, nasopharynx, etc.);
- Serious physical diseases (cancer, fracture, etc.);
- Other mental disorders (mania, schizophrenia, etc.);
- Unconscious, unable to cooperate with the examination
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450001
Yi Li, +8618810838848, muziyi3696085@163.com
About this study
Official title: Cortical Activation and Functional Connectivity Changes During Swallowing in Patients With Dysphagia in Lateral Medullary Syndrome
The goal of this observational study is to detect the alteration of cortical activation and functional connectivity during swallowing in patients with Lateral Medullary Syndrome (LMS) dysphagia by functional near infrared spectroscopy (fNIRS). The main questions it aims to answer are:
- The alteration of cortical activation during swallowing in patients with LMS compared with healthy subjects.
- The alteration of cortical functional connectivity during swallowing in patients with LMS compared with healthy subjects. fNIRS will be used to detect cortical activation and functional connectivity during swallowing tasks in LMS patients and healthy subjects, and to compare the differences between patients and healthy subjects.
- Conditions
- Deglutition Disorders, Lateral Medullary Syndrome
- Being tested
- Functional near-infrared spectroscopy (fNIRS) detection
- Medical subject headings
- Deglutition Disorders, Lateral Medullary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional near-infrared spectroscopy (fNIRS) detectionOther
fNIRS( NirScan Danyang Huichuang Medical Equipment Co. Ltd., China) will be used to detect changes in HbO and HbR during rest and voluntary swallowing. The swallowing procedure will be used consisted of three phases of manipulations: 30-s resting state periods, 30-s swallowing periods and 30-s resting state periods. A pre-collection will be conducted before the formal collection so that the subjects could understand the test process. After the pre-collection, the subjects will take a rest for 5 minutes before the formal collection.
| Study group | Role | What they receive |
|---|---|---|
| LMS patients | The demographic characteristics will be collected, including sex, age, stroke duration, and lesion side; Penetration-aspiration (PAS) scale will be used to evaluate swallowing function. fNIRS will be used to detect changes in oxyhemoglobin (HbO) and deoxyhemoglobin (HbR) during rest and voluntary swallowing. Receives: Other: Functional near-infrared spectroscopy (fNIRS) detection | |
| healthy subjects | The demographic characteristics will be collected, including sex and age. fNIRS will be used to detect changes in oxyhemoglobin (HbO) and deoxyhemoglobin (HbR) during rest and voluntary swallowing. Receives: Other: Functional near-infrared spectroscopy (fNIRS) detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
cortical activation during swallowing
The NirSpark package will be used to preprocess and analyze the fNIRS data. The steps will be used to preprocess the data including: deleting irrelevant time intervals and unrelated artifacts; turning the intensity of light into optical density; choosing the band-pass filter to filter the noise and interference signals (0.01-0.2 Hz); translating optical density to the oxygen concentration in the blood; and setting the initial time of the hemodynamic response function (HRF) to 30 s and the end time to 60 s (the time for a single block paradigm). To analyze the HbO2 time-series data, a generalized linear model (GLM) will be used. The GLM could calculate the degree of matching between the experimental and ideal HRF values for each task and participant. The beta value, which represents the channel's level of cortical activation, will be utilized to estimate the HRF prediction of the HbO2 signal and can be used to represent the HRF function's peak value.
Measured: day 1
Secondary outcomes (1)
functional connectivity during swallowing
The Network module of NirSpark software was used to extract the HbO2 concentration change at each time point, analyze the Pearson correlation coefficient of HbO2 concentration in each channel on the time series, and define it as the functional connection strength between channels through Fisher-Z conversion.
The Network module of NirSpark software was used to extract the HbO2 concentration change at each time point, analyze the Pearson correlation coefficient of HbO2 concentration in each channel on the time series, and define it as the functional connection strength between channels through Fisher-Z conversion.
The Network module of NirSpark software was used to extract the HbO2 concentration change at each time point, analyze the Pearson correlation coefficient of HbO2 concentration in each channel on the time series, and define it as the functional connection strength between channels through Fisher-Z conversion.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start31 May 2023
- Primary completion31 Jan 2024 (estimated)
- Study completion15 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deglutition DisordersStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Yi, The First Affiliated Hospital of Zhengzhou University
- Investigators
- Yi Li, Study chair, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06208020
- Sponsor's protocol ID
- LMS dysphagia
- Status last verified
- Jan 2024
- First submitted
- 5 Jan 2024
- Last updated
- 19 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical Activation and Functional Connectivity Changes During Swallowing in Patients With Dysphagia in Lateral Medullary Syndrome
- ClinicalTrials.gov ID
- NCT06208020
- Acronym / sponsor ID
- LMS dysphagia
- Conditions
- Deglutition Disorders, Lateral Medullary Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 31 May 2023 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 15 Feb 2024 (estimated)
- First posted
- 17 Jan 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.
The goal of this observational study is to detect the alteration of cortical activation and functional connectivity during swallowing in patients with Lateral Medullary Syndrome (LMS) dysphagia by functional near infrared spectroscopy (fNIRS). The main questions it aims to answer are:
- The alteration of cortical activation during swallowing in patients with LMS compared with healthy subjects.
- The alteration of cortical functional connectivity during swallowing in patients with LMS compared with healthy subjects. fNIRS will be used to detect cortical activation and functional connectivity during swallowing tasks in LMS patients and healthy subjects, and to compare the differences between patients and healthy subjects.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LMS patients | – | Other: Functional near-infrared spectroscopy (fNIRS) detectionThe demographic characteristics will be collected, including sex, age, stroke duration, and lesion side; Penetration-aspiration (PAS) scale will be used to evaluate swallowing function. fNIRS will be used to detect changes in oxyhemoglobin (HbO) and deoxyhemoglobin (HbR) during rest and voluntary swallowing. |
| healthy subjects | – | Other: Functional near-infrared spectroscopy (fNIRS) detectionThe demographic characteristics will be collected, including sex and age. fNIRS will be used to detect changes in oxyhemoglobin (HbO) and deoxyhemoglobin (HbR) during rest and voluntary swallowing. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with dysphagia in LMS and healthy adults will be enrolled.
Key inclusion criteria (5 listed)
- The first ischemic stroke was confirmed by head MRI as LMS;
- 18-80 years old, right-handed;
- Dysphagia was confirmed by video fluoroscopic swallow study(VFSS);
- Conscious enough to cooperate with fNIRS testing;
- No previous neurological or mental illness.
Key exclusion criteria (5 listed)
- Other central nervous system diseases (Parkinson's disease, Alzheimer's disease, intracranial tumors, etc.);
- Other diseases causing dysphagia (tumors of the esophagus, larynx, nasopharynx, etc.);
- Serious physical diseases (cancer, fracture, etc.);
- Other mental disorders (mania, schizophrenia, etc.);
- Unconscious, unable to cooperate with the examination
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 |
|---|---|---|
| Functional near-infrared spectroscopy (fNIRS) detectionfNIRS( NirScan Danyang Huichuang Medical Equipment Co. Ltd., China) will be used to detect changes in HbO and HbR during rest and voluntary swallowing. The swallowing procedure will be used consisted of three phases of manipulations: 30-s resting state periods, 30-s swallowing periods and 30-s resting state periods. A pre-collection will be conducted before the formal collection so that the subjects could understand the test process. After the pre-collection, the subjects will take a rest for 5 minutes before the formal collection. | Other | LMS patients, healthy subjects |
Primary outcome
cortical activation during swallowing
Time frame: day 1
The NirSpark package will be used to preprocess and analyze the fNIRS data. The steps will be used to preprocess the data including: deleting irrelevant time intervals and unrelated artifacts; turning the intensity of light into optical density; choosing the band-pass filter to filter the noise and interference signals (0.01-0.2 Hz); translating optical density to the oxygen concentration in the blood; and setting the initial time of the hemodynamic response function (HRF) to 30 s and the end time to 60 s (the time for a single block paradigm). To analyze the HbO2 time-series data, a generalized linear model (GLM) will be used. The GLM could calculate the degree of matching between the experimental and ideal HRF values for each task and participant. The beta value, which represents the channel's level of cortical activation, will be utilized to estimate the HRF prediction of the HbO2 signal and can be used to represent the HRF function's peak value.
1 secondary outcome
functional connectivity during swallowing
Time frame: day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Individual participant dataSharing planned: No. 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.
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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.
Yi Li study chair
The First Affiliated Hospital of Zhengzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deglutition Disorders and Lateral Medullary Syndrome, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
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 5 inclusion and 5 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 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Yi Li, Master (+8618810838848, muziyi3696085@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cortical activation during swallowing (time frame: day 1). 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 19 Jan 2024.