UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063292 |
|---|---|
| Receipt number | R000072444 |
| Scientific Title | Investigation of the mechanism of chronic dizziness using oculomotor recordings |
| Date of disclosure of the study information | 2026/10/15 |
| Last modified on | 2026/10/15 13:14:02 |
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Basic information
Public title
Investigation of disease mechanism of chronic dizziness using oculomotor recordings
Acronym
Oculomotor investigation of chronic dizziness
Scientific Title
Investigation of the mechanism of chronic dizziness using oculomotor recordings
Scientific Title:Acronym
Oculomotor recordings of chronic dizziness
Region
| Japan |
Condition
Condition
MdDS (Mal de Debarquement Syndrome), PPPD (Persistent Postural-Perceptual Dizziness), Chronic unilateral vestibulopathy
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of the present study is to investigate the symptoms and objective physiological findings (ocular movements, posturography) by comparing between MdDS, PPPD, chronic unilateral vestibulopathy and healthy participants.The secondary objective is to observe the whether the effect of readaptation, a method that is used to decrease the symptoms of MdDS, also applies to patients with PPPD and chronic unilateral vestibulopathy, while analyzing the physiological response including spatial orientation and vestibular adaptation during the readaptation stimulation. The present study is exploratory, and aims to obtain the baseline findings in order to understand the pathological mechanism of chronic dizziness, and to build the foundation for future research on treatment of MdDS and PPPD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Oculomotor findings (spontaneous nystagmus, cross-coupling, vergence, time constant of vestibulo-ocular reflex) and its comparison between MdDS, PPPD, chronic unilateral vestibulopathy and healthy participants.
Key secondary outcomes
Direction, velocity of optokinetic stimulation and direction and frequency of head movement during readaptation, as well as oculomotor findings during the stimulation and posturography before and after the readaptation.
Ratio of participants in whom the specific stimulatory conditions (as above) was successfully established, their conditions itself and the number of visits required for confirmation.
Change in symptoms (MdDS score for MdDS, NPQ for PPPD and DHI for chronic unilateral vestibulopathy) before and after the readaptation.
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
4
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Regarding MdDS patients,
Oculomotor recordings such as spontaneous nystagmus, Listing Plane determination, cross-coupling, vergence. Time constant of vestibule-ocular reflex using rotational chair test, posturography
Oculomotor recordings during readaptation stimulation.
Participant will be asked to visit for 1-2 hours, four times per month for 1 or 2 months duration.
Interventions/Control_2
Regarding PPPD patients,
Oculomotor recordings such as spontaneous nystagmus, Listing Plane determination, cross-coupling, vergence. Time constant of vestibule-ocular reflex using rotational chair test, posturography
Oculomotor recordings during readaptation stimulation.
Participant will be asked to visit for 1-2 hours, four times per month for 1 or 2 months duration.
Interventions/Control_3
Regarding chronic unilateral vestibulopathy patients,
Oculomotor recordings such as spontaneous nystagmus, Listing Plane determination, cross-coupling, vergence. Time constant of vestibule-ocular reflex using rotational chair test, posturography
Oculomotor recordings during readaptation stimulation.
Participant will be asked to visit for 1-2 hours, four times per month for 1 or 2 months duration.
Interventions/Control_4
Regarding healthy participants,
Oculomotor recordings such as spontaneous nystagmus, Listing Plane determination, cross-coupling, vergence. Time constant of vestibule-ocular reflex using rotational chair test, posturography
Oculomotor recordings during readaptation stimulation.
Required to visit only once, of 2 hours duration.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
MdDS group - outpatient, fulfills the Barany diagnostic criteria of MdDS
PPPD - outpatient, fulfills the Barany diagnostic criteria of PPPD with NPQ of 27 points and above, and NPQ visual score of 9 points and above
Chronic unilateral vestibulopathy - outpatient, with one-sided vestibular impairment as evidenced by more than 25% of canal paresis during caloric stimulation, or maximum eye velocity of less than 6 degrees per second, or video hit impulse with gain of 0.7 or less, or asymmetry ratio of 0.3 or more. Does not fulfill the Barany society criteria of MdDS or PPPD and NPQ is less than 27 with NPQ visual score of less than 8.
Healthy participant - no known inner ear or central pathologies. Age and sex-matched to MdDS group.
Key exclusion criteria
-A history of neurological or cranial nerve disorders
-Any disease or condition that prevents the neck movements required for the study
-Corrected visual acuity of 0.1 or worse on the decimal scale (eyeglasses cannot be worn with the VR headset used in this study)
-Inability to report or communicate subjective symptoms, including due to cognitive impairment
-Photosensitive epilepsy
-Failure to achieve at least 50% fixation suppression of nystagmus
-Any other condition that, in the judgment of the principal investigator or a physician serving as a co-investigator, makes participation inappropriate
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Ayame |
| Middle name | |
| Last name | Yamazaki |
Organization
Institute of Science Tokyo
Division name
Otorhinolaryngology
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5308
yamazaki.a.8583@m.isct.ac.jp
Public contact
Name of contact person
| 1st name | Ayame |
| Middle name | |
| Last name | Yamazaki |
Organization
Institute of Science Tokyo
Division name
Otorhinolaryngology
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5308
Homepage URL
yamazaki.a.8583@m.isct.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
Institute of Science Tokyo
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
Life Science and Bioethics Group, Institute of Science Tokyo
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-4547
rinri.adm@tmd.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
| 2026 | Year | 10 | Month | 15 | 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
| 2026 | Year | 10 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2028 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 15 | Day |
Last modified on
| 2026 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072444
