UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012437 |
|---|---|
| Receipt number | 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 20:45:59 |
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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
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
n.junji.0923@gmail.com
Sponsor or person
Institute
Nishiyamato Rehabilitaiton Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014554
