UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037152 |
|---|---|
| Receipt number | R000042156 |
| Scientific Title | Immediate effects of four-pole galvanic vestibular stimulation on patients with left hemispatial neglect. |
| Date of disclosure of the study information | 2019/06/25 |
| Last modified on | 2019/06/24 17:29:27 |
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Basic information
Public title
Immediate effects of four-pole galvanic vestibular stimulation on patients with left hemispatial neglect.
Acronym
Immediate effects of four-pole galvanic vestibular stimulation on patients with left hemispatial neglect.
Scientific Title
Immediate effects of four-pole galvanic vestibular stimulation on patients with left hemispatial neglect.
Scientific Title:Acronym
Immediate effects of four-pole galvanic vestibular stimulation on patients with left hemispatial neglect.
Region
| Japan |
Condition
Condition
Left unilateral spatial neglect patient, Left hemiplegic patient after stroke, healthy middle and old aged, healthy young people
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to use four-pole GVS for patients with unilateral spatial neglect patients, left hemiplegia after stroke, healthy adult, and healthy middle and old aged to establish new treatment methods.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective straight-ahead, seat pressure measurement, line bisection task, Catherine Bergego Scale.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved 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 |
Interventions/Control_1
Anodal stimulation for left mastoid and right temporal region induce LR-GVS.
Interventions/Control_2
Anodal stimulation for right mastoid and left temporal region induce RR-GVS.
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
| 22 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
USN group
1.Consciousness clear
2.Hemiparesis caused by single right-hemisphere stroke
3.Right-handed
4.NO cognitive impairment(HDS-R>21, MMSE>24)
5.BIT standard test<131.
Left hemiplegia group
1.2.3.4 is the same as the USN group
BIT standard test>131.
Health Group Middle and old Aged Group
Right-handed 40year to 80year.
Healthy young people
Right-handed 20year.
Key exclusion criteria
1. Bilateral or left-sided lesions.
2. Unable to sit on a wheelcair.
3. Patients who do not understand the instructions
4. Heart pacemaker, metallic brain implants, epilepsy, or sensitive skin.
5. Inability to give informed consent from.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kai |
| Middle name | |
| Last name | Kokuba |
Organization
Saitama misato general rehabilitation hospital
Division name
Department of Rihabilitation Medicine
Zip code
341-0034
Address
5-207 Shinwa, Misato city, Saitama
TEL
0489531211
kaichin0118@gmail.com
Public contact
Name of contact person
| 1st name | Kai |
| Middle name | |
| Last name | Kokuba |
Organization
Saitama misato general rehabilitation hospital
Division name
Department of Rihabilitation Medicine
Zip code
341-0034
Address
5-207 Shinwa, Misato city, Saitama
TEL
0489531211
Homepage URL
kaichin0118@gmail.com
Sponsor or person
Institute
Saitama misato general rehabilitation hospital
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
Saitama misato general rehabilitation hospital
Address
5-207 Shinwa, Misato city, Saitama
Tel
0489531211
kaichin0118@gmail.com
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
| 2019 | Year | 06 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2020 | 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
| 2019 | Year | 06 | Month | 24 | Day |
Last modified on
| 2019 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042156
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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