UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051844 |
|---|---|
| Receipt number | R000058514 |
| Scientific Title | A Randomized Controlled Trial on the Influence of galvanic vestibular stimulation on the recovery response: Focusing on Changes in Brain Activity and Muscle Activity |
| Date of disclosure of the study information | 2023/08/07 |
| Last modified on | 2023/08/07 07:24:41 |
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Basic information
Public title
A study to investigate the effects of electrical stimulation on the vestibular organs that maintain the body's balance on the balance response, focusing on changes in brain activity and muscle activity.
Acronym
Effects of Electrical Stimulation on Balance Ability
Scientific Title
A Randomized Controlled Trial on the Influence of galvanic vestibular stimulation on the recovery response: Focusing on Changes in Brain Activity and Muscle Activity
Scientific Title:Acronym
A randomized controlled trial of galvanic vestibular stimulation
Region
| Japan |
Condition
Condition
The subjects of this study will be healthy adults without pre-existing vestibular organ damage or neurological disorders, and the effects of galvanic vestibular stimulation on the human recovery response will be investigated. Based on the effects generated in healthy adults, we expect to be able to apply this method to rehabilitation of stroke patients in the future.
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It has been reported that galvanic vestibular stimulation can cause the body to tilt. Recently, this feature has been applied to the rehabilitation of verticality and spatial perception in stroke patients. The ability to sit balance in stroke survivors is also effective in predicting prognosis and is considered important. We could not find any reports on the use of galvanic vestibular stimulation for rehabilitation of sitting balance in stroke victims, or on changes in muscle activity and cerebral blood flow during body tilt induced by galvanic vestibular stimulation. Therefore, in this study, we decided to analyze muscle and brain activities during recovery exercise under galvanic vestibular electrical stimulation from an inclined plane in healthy subjects, in order to provide a basis for clinical application to stroke victims.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The participants will perform the righting reaction task under the condition of galvanic vestibular stimulation (intervention condition) and under the condition of no galvanic vestibular stimulation (sham condition).
The following items were measured for 1 minute during the standing righting reaction exercise in the intervention and sham conditions
Surface EMG: upper trapezius, paraspinal erector spinae, external oblique abdominal muscles, and rectus femoris
Cerebral blood flow: fNIRS
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The group will be divided into two groups depending on which of two conditions is initiated: the condition in which galvanic vestibular stimulation is given during righting reaction (intervention condition) or the sham condition.
In the intervention condition, electrodes of a direct current electrical stimulator (tDCS) are attached to the bilateral mastoid processes and stimulated at 1.0 mA for 2 minutes during recovery.
Interventions/Control_2
Sham stimulation. 1.0 mA galvanic vestibular electrical stimulation during the starting 10 s when the righting reaction exercise was started to be performed, after which the stimulation was stopped.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adults.
Right handed.
Key exclusion criteria
Exclude those with pre-existing vestibular or neurological disorders and those who cannot hold an sitting position for 30 minutes.
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Akari |
| Middle name | |
| Last name | Horikawa |
Organization
Faculty of Human Health Science, Tokyo Metropolitan University
Division name
Department of Physical Therapy
Zip code
116-8551
Address
7-2-10 Higashi-Ogu, Arakawa-ku, Tokyo, 116-8551, Japan
TEL
09053282960
22995806@ed.tmu.ac.jp
Public contact
Name of contact person
| 1st name | Akari |
| Middle name | |
| Last name | Horikawa |
Organization
Faculty of Human Health Science, Tokyo Metropolitan University
Division name
Department of Physical Therapy
Zip code
116-8551
Address
7-2-10 Higashi-Ogu, Arakawa-ku, Tokyo, 116-8551, Japan
TEL
09053282960
Homepage URL
ak.matsumoto929@gmail.com
Sponsor or person
Institute
other
Institute
Department
Personal name
Akari horikawa
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
none
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Faculty of Human Health Science, Tokyo Metropolitan University
Address
7-2-10 Higashi-Ogu, Arakawa-ku, Tokyo, 116-8551, Japan
Tel
09053282960
ak.matsumoto929@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
none
Org. issuing International ID_1
none
Study ID_2
none
Org. issuing International ID_2
none
IND to MHLW
none
Institutions
Institutions
Faculty of Human Health Science, Tokyo Metropolitan University
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 07 | 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
| 2023 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 31 | 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
| 2023 | Year | 08 | Month | 07 | Day |
Last modified on
| 2023 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058514
