UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050721 |
|---|---|
| Receipt number | R000057788 |
| Scientific Title | Motor coordination of Laryngeal closure during swallowing in patients with Parkinson's disease (Four-dimensional evaluation using 320-row Area Detector CT) |
| Date of disclosure of the study information | 2023/03/30 |
| Last modified on | 2023/03/30 11:19:13 |
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Basic information
Public title
Motor coordination of Laryngeal closure during swallowing in patients with Parkinson's disease
(Four-dimensional evaluation using 320-row Area Detector CT)
Acronym
Motor coordination of Laryngeal closure during swallowing in patients with Parkinson's disease
(Four-dimensional evaluation using 320-row Area Detector CT)
Scientific Title
Motor coordination of Laryngeal closure during swallowing in patients with Parkinson's disease
(Four-dimensional evaluation using 320-row Area Detector CT)
Scientific Title:Acronym
Motor coordination of Laryngeal closure during swallowing in patients with Parkinson's disease
(Four-dimensional evaluation using 320-row Area Detector CT)
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Medicine in general | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
More than half of patients with Parkinson's disease have dysphagia, which does not necessarily correlate with the severity of Parkinson's disease and may appear early in the course of the disease. Silent aspiration is frequently observed and is a factor in the deterioration of the general condition.
The characteristics of dysmotility as a cause of dysphagia are not fully understood.
To elucidate the mechanism of aspiration in Parkinson's disease, we will analyze the movement of the laryngeal closure using 320-ADCT.
Basic objectives2
Others
Basic objectives -Others
kinematic analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Start time of laryngeal closure, duration
Laryngeal vestibular volume
Key secondary outcomes
Time of movement of various organs of swallowing other than the larynx
Distance of hyoid-laryngeal movement
Upper Esophageal sphincter opening area
Pharyngeal volume
Laryngeal penetration and aspiration during swallowing
EAT-10/PILL-5
Correlation between CT swallowing index and severity of motor and non-motor symptoms of Parkinson's disease
Correlation with brain MRI and dopamine and serotonin transporter imaging findings
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
320-ADCT imaging of swallowing
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with Parkinson's disease who were inpatients or outpatients at our Neurology Department.
Patients who have been evaluated for swallowing function, are taking three meals orally.
Patients are in stable general condition, and have given informed consent for this study.
Key exclusion criteria
1. patients who are not medically stable
2. patients who are unable to perform voluntary movements due to impaired consciousness
3. patients who receive nutrition by tube feeding
4. other patients deemed inappropriate by the principal investigator and study coordinators
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University
Division name
Dept. of Rehabilitation Medicine I, School of Medicine
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
TEL
0562-93-2167
rehabmed@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Seiko |
| Middle name | |
| Last name | Shibata |
Organization
Fujita Health University
Division name
Dept. of Rehabilitation Medicine I, School of Medicine
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
TEL
0562-93-2167
Homepage URL
sshibata@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Fujita Health University
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
Tel
0562-93-2865
f-irb@fujita-hu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 30 | Day |
Last modified on
| 2023 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057788
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
