UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026470 |
|---|---|
| Receipt number | R000030402 |
| Scientific Title | Effect of interference wave stimulation on swallowing function |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2021/09/13 07:12:16 |
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Basic information
Public title
Effect of interference wave stimulation on swallowing function
Acronym
Effect of interference wave on swallowing improvement
Scientific Title
Effect of interference wave stimulation on swallowing function
Scientific Title:Acronym
Effect of interference wave on swallowing improvement
Region
| Japan |
Condition
Condition
Healthy young and elderly volunteer
Classification by specialty
| Rehabilitation medicine | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effect of interference wave stimulation on swallowing function and investigating how interference wave stimulation contributes on improvement of swallowing function and applying it for the rehabilitation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Motor Evoked potentials of pharyngeal area induced by transcranial magnetic stimulation and latency time measured using simple swallowing provocation test.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
10 minutes interference wave stimulation
Interventions/Control_2
10 minutes Sham stimulation
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy volunteer without swallowing dysfunction
Key exclusion criteria
Medical history of epilepsy, medication for brain excitability change, using artificial cardiac pacemaker and using metal implantation in head area
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jin Magara |
Organization
Niigata university Medical and dental hospital
Division name
Dysphagia rehabilitation unit
Zip code
Address
754, 1ban-cho, asahimachi, chu-oku, Niigata
TEL
0252272999
jin-m@dent.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jin Magara |
Organization
Niigata university Medical and dental hospital
Division name
Dysphagia rehabilitation unit
Zip code
Address
754, 1ban-cho, asahimachi, chu-o-ku, Niigata
TEL
0252272999
Homepage URL
jin-m@dent.niigata-u.ac.jp
Sponsor or person
Institute
Niigata university Medical and dental hospital
Dysphagia rehabilitation unit
Institute
Department
Personal name
Funding Source
Organization
KAKENHI (Grants-in-Aid for Scientific Research) Grant-in-Aid for Young Scientists (B)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
15
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
Main results already published
Date of protocol fixation
| 2017 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | 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
| 2017 | Year | 03 | Month | 09 | Day |
Last modified on
| 2021 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030402
| Research Plan | |
|---|---|
| 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 |
