UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059391 |
|---|---|
| Receipt number | R000067923 |
| Scientific Title | Study on Spatial Cognitive and Higher-order Brain Functions in Patients with Dizziness |
| Date of disclosure of the study information | 2025/10/14 |
| Last modified on | 2025/10/14 15:31:48 |
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Basic information
Public title
Study on Spatial Cognitive and Higher-order Brain Functions in Patients with Dizziness
Acronym
Study on Spatial Cognitive and Higher-order Brain Functions in Patients with Dizziness
Scientific Title
Study on Spatial Cognitive and Higher-order Brain Functions in Patients with Dizziness
Scientific Title:Acronym
Study on Spatial Cognitive and Higher-order Brain Functions in Patients with Dizziness
Region
| Japan |
Condition
Condition
Dizziness, Vertigo
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate spatial cognitive function in patients with vertigo using a virtual reality (VR)-based Morris water maze and to examine how vestibular function correlates with higher-order brain functions.
Basic objectives2
Others
Basic objectives -Others
The aim of this study is to evaluate spatial cognitive function in patients with vertigo using a virtual reality (VR)-based Morris water maze and to examine how vestibular function correlates with higher-order brain functions.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the relationship between vertigo and spatial cognitive function
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Evaluation of spatial cognitive function using a virtual reality (VR)-based Morris water maze (vertigo group)
Interventions/Control_2
Evaluation of spatial cognitive function using a virtual reality (VR)-based Morris water maze (control group))
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Vertigo group
Patients who visited the Department of Otorhinolaryngology, University of Toyama, with symptoms of vertigo
Patients who are able to undergo detailed vestibular function testing
Control group
Individuals without symptoms of vertigo who are deemed suitable by an otorhinolaryngologist
Key exclusion criteria
Individuals diagnosed with dementia
Individuals who are unable to undergo cognitive function testing
Individuals with neurological disorders identified on MRI
Individuals with psychiatric disorders or other conditions that may affect cognitive function, or those receiving treatments that may influence cognitive function
Individuals deemed inappropriate for inclusion by the attending otorhinolaryngologist
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | Morita |
Organization
University of Toyama
Division name
Department of Otorhinolaryngology-Head and Neck Surgery
Zip code
930-0194
Address
2630 Sugitani, Toyama city, Toyama Prefecture
TEL
+81764347650
yukam@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | Nakajima |
Organization
University of Toyama
Division name
Department of Otorhinolaryngology-Head and Neck Surgery
Zip code
930-0194
Address
2630 Sugitani, Toyama city, Toyama Prefecture
TEL
+81764347650
Homepage URL
jnknkj@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Center for Clinical Research, Toyama University Hospital
Address
2630 Sugitani, Toyama city, Toyama Prefecture
Tel
0764342281
rinri@adm.u-toyama.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
富山大学附属病院（富山県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 14 | 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 | 08 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | 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 | 10 | Month | 14 | Day |
Last modified on
| 2025 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067923
