UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054000 |
|---|---|
| Receipt number | R000061650 |
| Scientific Title | Effects of Transcranial Direct Current Stimulation to the cerebellum and Gaze Stabilization Exercises on the Vestibulospinal Tract |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/03/29 01:31:38 |
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Basic information
Public title
Effects of Transcranial Direct Current Stimulation to the cerebellum and Gaze Stabilization Exercises on the Vestibulospinal Tract
Acronym
Effects of Transcranial Direct Current Stimulation to the cerebellum and Gaze Stabilization Exercises on the Vestibulospinal Tract
Scientific Title
Effects of Transcranial Direct Current Stimulation to the cerebellum and Gaze Stabilization Exercises on the Vestibulospinal Tract
Scientific Title:Acronym
Effects of Transcranial Direct Current Stimulation to the cerebellum and Gaze Stabilization Exercises on the Vestibulospinal Tract
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we aim to examine the effects of transcranial direct current stimulation to the cerebellum and gaze stabilization exercises on the vestibulospinal tract.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the soleus H reflex amplitude with galvanic vestibular stimulation
the velocity of the center of pressure
the area of the center of pressure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
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 | Other |
Interventions/Control_1
Cathodal transcranial direct current stimulation to the cerebellum and Gaze Stabilization Exercises
Interventions/Control_2
Gaze Stabilization Exercises
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults
Participants who agree to participate in this study
Key exclusion criteria
Participants with a history of orthopedic disease
Participants with a history of neurological disease
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Osuke |
| Middle name | |
| Last name | Shibata |
Organization
International university of health and welfare graduate school
Division name
Faculty of Health Sciences, Department of Physical Therapy
Zip code
814-0001
Address
2-4-16 Momochihama, Sawaraku, Fukuoka, Japan
TEL
092-407-0434
23s1084@g.iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Osuke |
| Middle name | |
| Last name | Shibata |
Organization
International university of health and welfare graduate school
Division name
Faculty of Health Sciences, Department of Physical Therapy
Zip code
814-0001
Address
2-4-16 Momochihama, Sawaraku, Fukuoka, Japan
TEL
092-407-0434
Homepage URL
23s1084@g.iuhw.ac.jp
Sponsor or person
Institute
International university of health and welfare graduate school
Institute
Department
Personal name
Funding Source
Organization
none
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
International university of health and welfare graduate school ethics review committee
Address
182-2 Enokizu, Okawa, Fukuoka, Japan
Tel
0944-89-2031
q-rinri@iuhw.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
| 2024 | Year | 04 | Month | 01 | 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
14
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 03 | Month | 29 | Day |
Last modified on
| 2024 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061650
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
