Status Approved
First Submitted Date
2022/06/10
Registered Date
2022/06/23
Last Updated Date
2022/06/10
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
| CRIS Registration Number |
KCT0007438 |
|---|---|
| Unique Protocol ID | DSMC 2021-12-025 |
| Public/Brief Title | Tongue muscle assessment using ultrasonography to evaluate dysphagia severity in patient with Amyotrophic lateral sclerosis |
| Scientific Title | Tongue muscle assessment using ultrasonography to evaluate dysphagia severity in patient with Amyotrophic lateral sclerosis |
| Acronym | Swallowing Tongue assessment in Amyotrophic Lateral Sclerosis (STALS) |
| MFDS Regulated Study | No |
| IND/IDE Protocol | No |
| Registered at Other Registry | No |
| Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
| Board Approval Status | Submitted approval |
|---|---|
| Board Approval Number | DSMC 2021-12-025 |
| Approval Date | 2021-12-29 |
| Institutional Review Board Name | Institutional Review Board of Keimyung university dongsan medical center |
| Institutional Review Board Address | 1035, Dalgubeol-daero, Dalseo-gu, Daegu, Republic of Korea |
| Institutional Review Board Telephone | 053-258-6698 |
| Data Monitoring Committee | No |
3. Contact Details
| Contact Person for Principal Investigator / Scientific Queries | |
|---|---|
| Name | Kyoung Tae Kim |
| Title | Assistant professor |
| Telephone | +82-53-258-7692 |
| Affiliation | Keimyung University Dongsan Hospital |
| Address | 1035, Dalgubeol-daero, Dalseo-gu, Daegu, Republic of Korea |
| Contact Person for Public Queries | |
| Name | Kyoung Tae Kim |
| Title | Assistant professor |
| Telephone | +82-53-258-7692 |
| Affiliation | Keimyung University Dongsan Hospital |
| Address | 1035, Dalgubeol-daero, Dalseo-gu, Daegu, Republic of Korea |
| Contact Person for Updating Information | |
| Name | Kyoung Tae Kim |
| Title | Assistant professor |
| Telephone | +82-53-258-7692 |
| Affiliation | Keimyung University Dongsan Hospital |
| Address | 1035, Dalgubeol-daero, Dalseo-gu, Daegu, Republic of Korea |
4. Status
| Study Site | Single | |
|---|---|---|
| Overall Recruitment Status | Recruiting | |
| Date of First Enrollment | 2021-12-29 Actual | |
| Target Number of Participant | 30 | |
| Primary Completion Date | 2023-12-31 , Anticipated | |
| Study Completion Date | 2024-03-31 , Anticipated | |
| Recruitment Status by Participating Study Site 1 | ||
| Name of Study | Keimyung University Dongsan Hospital | |
| Recruitment Status | Recruiting | |
| Date of First Enrollment | 2021-12-29 , | |
5. Source of Monetary / Material Support
| 1. Source of Monetary/Material Support | |
|---|---|
| Organization Name | Keimyung University Dongsan Hospital |
| Organization Type | Medical Institute |
| Project ID | DSMC 2021-12-025 |
6. Sponsor Organization
| 1. Sponsor Organization | |
|---|---|
| Organization Name | Keimyung University Dongsan Hospital |
| Organization Type | Medical Institute |
7. Study Summary
| Lay Summary | Amyotrophic lateral sclerosis (ALS) as a motor neuron disease is a rare disease for which there is no clear cure yet. Swallowing disorder is one of the main symptoms of patients with advanced amyotrophic lateral sclerosis, which causes pneumonia and various complications due to malnutrition and aspiration. In particular, in patients with severe bulbar symptom, oral phase impairments are prominent due to muscle loss and muscle weakness around the oral cavity, and lip sealing and tongue movement impairment occur. The video fluoroscopic swallowing study (VFSS) is the gold standard for the evaluation of patients with swallowing disorders, but due to the nature of the disease in progress, the amount of radiation exposure is high due to repeated tests every few months. In addition, there is a limitation in that it is difficult to evaluate the characteristics or quantitative evaluation of swallowing disorders that are different from other diseases in patients with ALS. Ultrasonography is a non-invasive,radiation-free imaging stduy that can be evaluated in a short time. It has been known as a useful assessment tool to evaluate swallowing disorders due to loss of the tongue muscle among the symptoms of ALS. In this study, not only a simple comparison between ultrasound and videofluoroscopic swallowing test, but also the change and correlation with time in various aspects such as the patient's nutritional status, disease severity, and quality of life were investigated. |
|---|
8. Study Design
| Study Type | Observational Study |
|---|---|
| Observational Study Model | Cohort |
| Time Perspective | Prospective |
| Target Number of Participant | 30 |
| Cohort/Group Number | 1 |
|
Cohort/ Group 1 |
Cohort/Group Label ALS_dysphagia |
|
Cohort/Group Description 1. Tongue evaluation using ultrasound (thickness, cross sectional area)
2. Hand grip strength using dynamometer
3. clinical assessment using structured questionnaire and severity evaluation
: K-ALS-FRS, ASHA-NOMS, FOIS, DHI, EAT-10, K-SWAL-QOL, MNA-SF
4. VFSS
5. muscle quantity evaluation using DEXA
6. BMD
7. Evaluation time line T0 : initial / T1: 6mo / T2: 12mo
(BMD at T0, T2)
|
|
| Biospecimen Collection & Archiving |
Not collect nor Archive |
| Biospecimen Description |
9. Subject Eligibility
| Study Population Description | Adults over 20 years old who have dysphagia among patients diagnosed with amyotrophic lateral sclerosis and who regularly visit the outpatient department of rehabilitation at our hospital. |
|---|---|
| Sampling Method | Non-probablity sampling : convenience sampling The study was conducted after obtaining consent from those who met the inclusion/exclusion criteria among ALS patients who visited the Department of Rehabilitation. |
| Condition(s)/Problem(s) |
* (G00-G99)Diseases of the nervous system (G12.2)Motor neuron disease Amyotrophic Lateral Sclerosis |
| Rare Disease | Yes |
| Inclusion Criteria |
Gender Both |
|
Age 19Year~No Limit |
|
|
Description - Those with dysphagia among patients diagnosed with amyotrophic lateral sclerosis - Adults 19 years of age or older - Those who understand the explanation of this study and agree to participate |
|
| Exclusion Criteria |
- In case of severe cognitive impairment that cannot perform video fluoroscopy swallowing test - Inability to take a sitting position - In case of uncontrolled internal or surgical disease - Those with other neurological and structural diseases that may cause dysphagia |
| Healthy Volunteers | No |
10. Outcome Measure(s)
| Type of Primary Outcome | Not applicable | |
|---|---|---|
| Primary Outcome(s) 1 | ||
| Outcome | corrleation between tongue thickness and MBSImP total score |
|
| Timepoint | initial (T0), 6month (T1), 12month (T2) |
|
| Secondary Outcome(s) 1 | ||
| Outcome | corrleation between tongue thickness and clinical dysphagia severity aseesment (ASHA-NOMS, FOIS, DHI) |
|
| Timepoint | initial (T0), 6month (T1), 12month (T2) |
|
| Secondary Outcome(s) 2 | ||
| Outcome | corrleation between tongue thickness and severity of disease ( K-ALS-FRS) |
|
| Timepoint | initial (T0), 6month (T1), 12month (T2) |
|
| Secondary Outcome(s) 3 | ||
| Outcome | corrleation between tongue thickness and severity of disease ( K-ALS-FRS) |
|
| Timepoint | initial (T0), 6month (T1), 12month (T2) |
|
| Secondary Outcome(s) 4 | ||
| Outcome | corrleation between tongue thickness and nutritional status (MNA-SF) |
|
| Timepoint | initial (T0), 6month (T1), 12month (T2) |
|
| Secondary Outcome(s) 5 | ||
| Outcome | corrleation between tongue thickness and skeletal muscle index (SMI : appendicular limb mass / height 2) |
|
| Timepoint | initial (T0), 6month (T1), 12month (T2) |
|
11. Study Results and Publication
| Result Registered | No |
|---|
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
| Sharing Statement | No |
|---|
TOP
BOTTOM
화면 최하단으로 이동
