UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051241 |
|---|---|
| Receipt number | R000058353 |
| Scientific Title | Verification of brain activation effect on swallowing function by Ice Stick. |
| Date of disclosure of the study information | 2023/06/12 |
| Last modified on | 2024/12/06 17:53:14 |
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Basic information
Public title
Brain Effects of Ice Stick on Swallowing Function
Acronym
Effects of Ice Sticks on the Brain
Scientific Title
Verification of brain activation effect on swallowing function by Ice Stick.
Scientific Title:Acronym
Ice Stick's effect on stimulating swallowing
Region
| Japan |
Condition
Condition
dysphagia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The activation effect of ice massage on the brain regarding swallowing function is measured using fNIRS.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Cerebral blood flow information by fNIRS during swallowing
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intraoral ice massage using ice sticks
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy subjects who gave consent to participate in this study
Key exclusion criteria
History of stroke, head and neck treatment, or other neurological conditions that may require impairment of swallowing function, or history of such conditions.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Tazawa |
Organization
Gunma University Graduate School of Medicine
Division name
Depertment of Rehabilitation Medicine
Zip code
371-8511
Address
62-11,3-tyoume, Shouwa-machi, Maebashi, Gunma, Japan
TEL
0272578655
mastaz1@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Tazawa |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
371-8511
Address
62-11, 3-tyoume, Shouwa-machi, Maebashi, Gunma, Japan
TEL
0272578655
Homepage URL
mastaz1@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Masayuki Tazawa
Funding Source
Organization
Gunma 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
Gunma University Hospital Clinical Research Review Board
Address
39-15, 3-tyoume, shouwa-machi, Maebashi, Gunma, Japan
Tel
81-27-220-8747
ciru_hitotaisho-irb@ml.gunma-u.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 | 06 | Month | 12 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 10 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 02 | Day |
Last modified on
| 2024 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058353
