UMIN-CTR Clinical Trial

Public title

Effect of vestibular stimulation on subjective visual vertical in patients with hemiparetic stroke

Acronym

Effect of vestibular stimulation on subjective visual vertical in patients with hemiparetic stroke

Scientific Title

Effect of vestibular stimulation on subjective visual vertical in patients with hemiparetic stroke

Scientific Title:Acronym

Effect of vestibular stimulation on subjective visual vertical in patients with hemiparetic stroke

Region

Japan

Condition

Stroke

Classification by specialty

Neurology	Oto-rhino-laryngology	Neurosurgery
Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To know the effect that occurs to the hemiparesis patients by the vestibular stimulation and to know the efficacy of the vestibular stimulation for modifying warped equilibrium sense damaged by the cerebrovascular disease.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Subjective visual vertical

Key secondary outcomes

Study type

Interventional

Basic design

Factorial

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Institution is not considered as adjustment factor.

Blocking

Concealment

Pseudo-randomization

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Bipolar direct current electrical stimulation(1.5mA) is done by setting the electrode on the both side of mastoid to the right hemisphere lesion patients. Three types of stimulation, right-anode, left-anode, sham stimulation are done about 30 seconds at a time. The types of stimulation applied to the subjects are concealed, and the order of stimulations performed are selected pseudo-randomly at each subject. 24 hours have to be past between each stimulation.

Interventions/Control_2

Bipolar direct current electrical stimulation(1.5mA) is done by setting the electrode on the both side of mastoid to the left hemisphere lesion patients. Three types of stimulation, right-anode, left-anode, sham stimulation is done about 30 seconds at a time. The types of stimulation applied to the subjects are concealed, and the order of stimulations performed are selected pseudo-randomly at each subject. 24 hours have to be past between each stimulation.

Interventions/Control_3

Bipolar direct current electrical stimulation(1.5mA) is done by setting the electrode on the both side of mastoid to the left hemisphere lesion patients. Three types of stimulation, right-anode, left-anode, sham stimulation is done about 30 seconds at a time. The types of stimulation applied to the subjects are concealed, and the order of stimulations performed are selected pseudo-randomly at each subject. 24 hours have to be past between each stimulation.

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

When it comes to patients, who suffered from hemiparesis by the first occurrence of stroke with supratentorial lesion at one side of the lobe, and who can sit still for about 30 seconds without any hold.

Key exclusion criteria

Who cannot be aware of the order for the experiments, and who have orthopedic disease or experience of orthopedic operation before, neurologic disease except the current stroke, otolaryngologic disease which has a influence for the vestibular function, past history of head injury, implanted electric devices such as pacemaker or VP shunt.

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Yohei Tomioka

Organization

Tokyo Bay Rehabilitation Hospital

Division name

Rehabilitation

Zip code

Address

4-1-1 Yatsu,Narashino-shi,Chiba

TEL

0474539000

Email

ytomi@keio.jp

Name of contact person

1st name
Middle name
Last name	Yohei Tomioka

Organization

Tokyo Bay Rehabilitation Hospital

Division name

Rehabilitation

Zip code

Address

4-1-1 Yatsu,Narashino-shi,Chiba

TEL

0474539000

Homepage URL

Email

ytomi@keio.jp

Institute

Tokyo Bay Rehabilitation Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

02

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2012

Year

07

Month

23

Day

Date of IRB

Anticipated trial start date

2012

Year

10

Month

16

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

02

Month

11

Day

Last modified on

2018

Year

05

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035680