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

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 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


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

Value
https://center6.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