UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059978 |
|---|---|
| Receipt number | R000068609 |
| Scientific Title | Verification of the Effect of Oral Stimulation Duration via Ice Massage on Activation of Brain Regions Related to Swallowing |
| Date of disclosure of the study information | 2025/12/05 |
| Last modified on | 2025/12/04 18:00:23 |
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Basic information
Public title
Verification of the Effect of Oral Stimulation Duration via Ice Massage on Activation of Brain Regions Related to Swallowing
Acronym
Verification of the Relationship between Oral Cooling Stimulation Duration and Brain Activation Effects
Scientific Title
Verification of the Effect of Oral Stimulation Duration via Ice Massage on Activation of Brain Regions Related to Swallowing
Scientific Title:Acronym
Verification of the Relationship between Oral Cooling Stimulation Duration and Brain Activation Effects
Region
| Japan |
Condition
Condition
dysphagia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will investigate whether the duration of oral stimulation via ice massage affects the activation of swallowing function and swallowing-related brain regions (VLPFC: ventrolateral prefrontal cortex and DLPFC: dorsolateral prefrontal cortex) using fNIRS.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in Oxy-Hb concentration during fNIRS in the continuous saliva swallowing test following intraoral ice massage
Key secondary outcomes
Number of swallows, latency of first swallow, and subjective ease of swallow during the continuous saliva swallowing test following intraoral ice massage
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Intraoral ice massage using an intraoral cooling device (Ice Stick)
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Adults aged 18 to 60 inclusive who consented to participate in this study
Key exclusion criteria
A history of cerebral infarction or head and neck treatment, or other neurological conditions that may impair swallowing function, either currently present or in the past.
Cognitive impairment that prevents following instructions.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | MASA |
| Middle name | |
| Last name | TAZAWA |
Organization
Gunma Univesity graduate school of medicine
Division name
rehabilitation medicine
Zip code
371-0837
Address
39-22 3-tyoume, syouwamachi, Maebashishi, 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 Univesity graduate school of medicine
Division name
Rehabilitation medicine
Zip code
371-8511
Address
39-22 3-tyoume, syouwamachi, Maebashishi, Gunma, Japan
TEL
0272578655
Homepage URL
mastaz1@gunma-u.ac.jp
Sponsor or person
Institute
Gunma Univesity
Institute
Department
Personal name
MASAYUKI TAZAWA
Funding Source
Organization
Gunma Univesity
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 univesity
Address
39-22 3-tyoume, syouwamachi, Maebashishi, Gunma, Japan
Tel
0272578655
mastaz1@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
群馬県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 26 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2028 | 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
| 2025 | Year | 12 | Month | 04 | Day |
Last modified on
| 2025 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068609
