UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	Trial on the effect of long noisy galvanic vestibular stimulation in bilateral vestibulopathy
Region	Japan

Condition
Condition	bilateral vestibulopathy
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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

Base
Study type	Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Shinichi Iwasaki
Organization	University of Tokyo
Division name	Hospital
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL	0358008665
Email	iwashin-tky@umin.ac.jp

Public contact
Name of contact person	Shinichi Iwasaki
Organization	University of Tokyo
Division name	Hospital
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL	0358008665
Homepage URL
Email	iwashin-tky@umin.ac.jp

Sponsor
Institute	University of Tokyo Hospital
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	JAPAN

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

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	東京大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 04 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
Other related information

Management information
Registered date	2017 Year 07 Month 03 Day
Last modified on	2017 Year 07 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032122