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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000037152
Receipt No. 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

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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
Email 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
Email kaichin0118@gmail.com

Sponsor
Institute Saitama misato general rehabilitation hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042156

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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