UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044730 |
|---|---|
| Receipt number | R000051076 |
| Scientific Title | Unraveling of neural basis of voluntary cough and cough reflex |
| Date of disclosure of the study information | 2021/07/05 |
| Last modified on | 2023/05/16 20:45:39 |
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Basic information
Public title
Unraveling of neural basis of voluntary cough and cough reflex
Acronym
Unraveling of neural basis of voluntary cough and cough reflex
Scientific Title
Unraveling of neural basis of voluntary cough and cough reflex
Scientific Title:Acronym
Unraveling of neural basis of voluntary cough and cough reflex
Region
| Japan |
Condition
Condition
aspiration pneumonia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the neural basis of coughing by examining changes in cerebral blood flow during coughing to understand the mechanism of brain activity.
Basic objectives2
Others
Basic objectives -Others
lucidation of the pathophysiology of brain activity
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Whole brain and Region of Interest (ROI) are used to compare the brain distribution (neural activity) of [15O]H2O during resting breathing, voluntary cough, cough suppression and cough induction.
Key secondary outcomes
Correlation between objective parameters of cough (PEFR) and brain activity (PET, MRI images)
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
| Medicine | Maneuver |
Interventions/Control_1
Intravenous administration of radioligand [15O]H2O followed by nebulizer-mediated inhalation of saline and 10% tartaric acid solution to induce cough and suppress cough by nebulizer-mediated inhalation of 10% tartaric acid solution. 4 tasks will be performed 3 times each and the duration is expected to be about 2 hours.
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
| 99 | years-old | > |
Gender
Male
Key inclusion criteria
Healthy male, 20 years of age or older, right hand dominant.
Key exclusion criteria
(1) Patients with epilepsy or complications from a serious disease, or those who have a history of epilepsy or complications from a serious disease and are judged by the physician as the researcher to be inappropriate for this study.
(2) Those who have a history of habitual smoking.
(3) Those who are dependent on alcohol.
(4)Those who have suffered from neuropsychiatric disease, neuromuscular disease, head and neck disease, respiratory disease, or allergic disease (including hay fever and atopy) in the past.
(5) Patients with a history of medication
(6) Those who cannot undergo MRI (pacemakers, those with internal metal (brain clips, bolts, etc.), those with tattoos (including tattoos and artistic makeup), those with claustrophobia, etc.)
(7) Those who have participated in nuclear medicine examinations of other healthy volunteers within one year.
(8) Any other person who is judged inappropriate as a research subject by the physician who is the researcher, etc.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Yasuomi |
| Middle name | |
| Last name | Ouchi |
Organization
Hamamatsu university school of medicine
Division name
Department of Biofunctional Imaging
Zip code
431-3192
Address
1-20-1, Handayama, Higashi-Ku, Hamamatsu, Shizuoka
TEL
053-435-2111
ouchi@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Takafumi |
| Middle name | |
| Last name | Sugi |
Organization
Hamamatsu university school of medicine
Division name
Department of Biofunctional Imaging
Zip code
431-3192
Address
1-20-1, Handayama, Higashi-Ku, Hamamatsu, Shizuoka
TEL
053-435-2111
Homepage URL
tsugi0217@me.com
Sponsor or person
Institute
Hamamatsu university school of medicine
Hamamatsu city rehabilitation hospital
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu university school of medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu university school of medicine
Address
1-20-1, Handayama, Higashi-Ku, Hamamatsu, Shizuoka
Tel
053-435-2680
rinri@hama-med.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
浜松市リハビリテーション病院(静岡県)
浜松医科大学(静岡県)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 05 | 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
Completed
Date of protocol fixation
| 2021 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2023 | 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
| 2021 | Year | 07 | Month | 01 | Day |
Last modified on
| 2023 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051076
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
