UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015341 |
|---|---|
| Receipt number | R000017840 |
| Scientific Title | The elucidation and clinical application of vestibular stimulation effect on imbalance of the dementia patients |
| Date of disclosure of the study information | 2014/10/05 |
| Last modified on | 2014/10/04 14:56:22 |
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Basic information
Public title
The elucidation and clinical application of vestibular stimulation effect on imbalance of the dementia patients
Acronym
Vestibular stimulation effect on dementia patients
Scientific Title
The elucidation and clinical application of vestibular stimulation effect on imbalance of the dementia patients
Scientific Title:Acronym
Vestibular stimulation effect on dementia patients
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Medicine in general | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The elucidation and clinical application of vestibular stimulation effect
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
caloric test
Key secondary outcomes
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Dementia patients with vestibular stimulation
Interventions/Control_2
Dementia patients with no vestibular 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Dementia ( e.g. Alzheimer's disease, frontotemporal dementia, vascular dementia)
Key exclusion criteria
any previous outer or middle ear diseases
sarcopenia
antipsychotic agent remedy
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Tamaoka |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Department of Neurology, Division of Clinical Medicine
Zip code
Address
Tennoudai 1-1-1, Tsukuba, Ibaraki 305-8575, Japan
TEL
029-853-3224
atamaoka@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiyotaka Nakamagoe |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Department of Neurology, Division of Clinical Medicine
Zip code
Address
Tennoudai 1-1-1, Tsukuba, Ibaraki 305-8575, Japan
TEL
029-853-3224
Homepage URL
Nakamagoek@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba Hosipital
Institute
Department
Personal name
Funding Source
Organization
Scientific Research (C) (No. 26460901) from the Ministry of Education, Culture, Sports, Science and Technology of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2014 | Year | 10 | 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
| 2014 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 04 | Day |
Last modified on
| 2014 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017840
