UMIN-CTR Clinical Trial

Public title

Exploratory trial on the carry-over effect, accumulation effect and safety of long-term noisy galvanic vestibular stimulation on improvement of body balance in patients with bilateral vestibulopathy

Acronym

Trial on the effect of long noisy galvanic vestibular stimulation in bilateral vestibulopathy

Scientific Title

Exploratory trial on the carry-over effect, accumulation effect and safety of long-term noisy galvanic vestibular stimulation on improvement of body balance in patients with bilateral vestibulopathy

Scientific Title:Acronym

Trial on the effect of long noisy galvanic vestibular stimulation in bilateral vestibulopathy

Region

Japan

Condition

bilateral vestibulopathy

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the carry-over effect, accumulation effect and safety of long-term noisy galvanic vestibular stimulation in patients with bilateral vestibulopathy

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

1. Changes in total length of the center of pressure (COP) from the baseline (From 0 to 3 h after the cessation of noisy galvanic vestibular stimulation)
2. Adverse events and troubles

Key secondary outcomes

1. Changes in envelopment area and root meas square (RMS) of COP from the baseline
2. Changes in gait velocity, step length and step time

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

To determine the optimal stimulus intensity of noisy GVS (0 - 1000 microA) using a stabilomenter.
To apply noisy GVS with the optimal intensity for each patient, and evaluate postural stability and gait performance from 0 to 6 h after the cessation of the stimulus.

Interventions/Control_2

Interventions/Control_3

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

85

years-old

>

Gender

Male and Female

Key inclusion criteria

Patients who showed corrective saccades to horizontal head impulses bilaterally, and showed reduced or absent caloric responses to ice water irrigation of the external auditory canal bilaterally (maximum slow phase eye velocity<10 deg/sec)

Key exclusion criteria

1)Metal in the body, including intracephalic aneurysm clips and pace makers
2)Orthopedic disease
3)Heart disease
4)Inability to walk without assistance
5)A malignant tumor
6)Medicated by any tranquilizers and/or antidepressants
7)Consumed alcohol after 10 PM the day prior to the trial
8) Deemed not eligible by the investigator (co-investigator)

Target sample size

13

Name of lead principal investigator

1st name
Middle name
Last name	Shinichi Iwasaki

Organization

University of Tokyo

Division name

Hospital

Zip code

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

TEL

0358008665

Email

iwashin-tky@umin.ac.jp

Name of contact person

1st name
Middle name
Last name	Shinichi Iwasaki

Organization

University of Tokyo

Division name

Hospital

Zip code

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

TEL

0358008665

Homepage URL

Email

iwashin-tky@umin.ac.jp

Institute

University of Tokyo Hospital

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

JAPAN

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

東京大学医学部附属病院

Date of disclosure of the study information

2017

Year

07

Month

05

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

In patients with bilateral vestibulopathy, noisy GVS significantly improved total length of COP for 3 h after the cessation of the stimulus. The envelopment area and RMS of the COP and gait performance were not kept improved by noisy GVS.

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

2016

Year

10

Month

04

Day

Date of IRB

Anticipated trial start date

2016

Year

10

Month

11

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

07

Month

03

Day

Last modified on

2017

Year

07

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032122