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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000012437
Receipt No. R000014554
Scientific Title Differential effects of galvanic vestibular stimulation parameters on unilateral spatial neglect in the patients with stroke.
Date of disclosure of the study information 2013/11/28
Last modified on 2015/11/10

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Basic information
Public title Differential effects of galvanic vestibular stimulation parameters on unilateral spatial neglect in the patients with stroke.
Acronym Differential effects of galvanic vestibular stimulation parameters on unilateral spatial neglect.
Scientific Title Differential effects of galvanic vestibular stimulation parameters on unilateral spatial neglect in the patients with stroke.
Scientific Title:Acronym Differential effects of galvanic vestibular stimulation parameters on unilateral spatial neglect.
Region
Japan

Condition
Condition Unilateral spatial neglect in right-hemisphere stroke patients.
Classification by specialty
Neurology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the differential effects of galvanic vestibular stimulation parameters on unilateral spatial neglect in patients with right-hemisphere stroke.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Line cancellation and Line bisection task.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 The cathode is placed on the left mastoid and the anode on the right mastoid(Left-GVS).The Left-GVS is delivered for 20 min.The intensity is set below the sensory threshold.
Interventions/Control_2 The cathode is placed on the right mastoid and the anode on the left mastoid(Right-GVS). The Right-GVS is delivered for 20 min. The intensity is set below the sensory threshold.
Interventions/Control_3 The 2 electrodes are positioned as in the L-GVS condition, except that no electric current is applied (sham-condition).The sham-GVS is delivered for 20 min.
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
30 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria 1.Hemiparesis caused by single right-hemisphere stroke between 30 and 180 days prior to study enrollment.
2.Right-handed.
3.No severe cognitive impairment (Mini-Mental State Examination, MMSE >15).
4.Less than the cutoff value in the standard test of the Behavioral Inattention Test.
Key exclusion criteria 1.Bilateral or left-sided lesions.
2.Unable to sit on a wheelchair.
3.Unable to understand the task because of aphasia or other cognitive impairment.
4.Extremely impaired eyesight.
5.Heart pacemaker, metallic brain implants, epilepsy, or sensitive skin.
6.Inability to give informed consent form.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junji Nakamura
Organization Nishiyamato Rehabilitaiton Hospital
Division name Department of Rehabilitation Medicine
Zip code
Address 3238-6, Kanmaki, Kanmaki-cho, Kitakatsuragi-gun, Nara
TEL 0745-71-6688
Email n.junji.0923@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Junji Nakamura
Organization Nishiyamato Rehabilitaiton Hospital
Division name Department of Rehabilitation Medicine
Zip code
Address 3238-6, Kanmaki, Kanmaki-cho, Kitakatsuragi-gun, Nara
TEL 0745-71-6688
Homepage URL
Email n.junji.0923@gmail.com

Sponsor
Institute Nishiyamato Rehabilitaiton Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2013 Year 11 Month 28 Day

Related information
URL releasing protocol
Publication of results Published

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 Main results already published
Date of protocol fixation
2013 Year 11 Month 28 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 11 Month 28 Day
Last modified on
2015 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014554

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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