臨床研究等提出・公開システム

Japanese

Date of registration	June. 12, 2024
Last modified on	April. 24, 2025
Trial ID	jRCTs042240042

Scientific Title	The Effective Stimulation Duration in Improving Balance with noisy galvanic vestibular stimulation
Public Title	Effective stimulation duration by nGVS

Contact for Scientific Queries	Name	Iwasaki Shinichi
	Affiliation	Nagoya City University Hospital
	Address	1 Kawasumi Mizuho-cho Mizuho-ku Nagoya Aichi 467-8602 Japan
	Telephone	+81-528538256
	E-mail	iwashin@med.nagoya-cu.ac.jp
Contact for Public Queries	Name	KABAYA KAYOKO
	Affiliation	Nagoya City University Hospital
	Address	1 Kawasumi Mizuho-cho Mizuho-ku Nagoya Aichi 467-8602 Japan
	Telephone	+81-528538256
	E-mail	kabaya@med.nagoya-cu.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 12, 2024
Actual date of first enrollment		Aug. 16, 2024
Target sample size		20
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	dose comparison control
	assignment	crossover assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Between the ages of 60 and 84 2. Healthy people without dizziness, hearing loss, and ear diseases 3. Written informed consent
	Exclusion Criteria	1. with metal in the body, such as cerebral artery clips or pacemakers 2. orthopedic conditions (especially acute painful conditions such as fractures, sprains, and separated flesh) 3. with heart disease 4. unable to walk independently 5. malignant tumor 6. sensory disturbance due to severe peripheral circulatory disturbance caused by diabetes mellitus, etc. 7. skin abnormality (infection, wound, etc.) at the electrode application site, or skin allergy to surface electrodes 8. taking tranquilizers or antidepressants 9. Those who drank alcohol after 10:00 p.m. on the day before the examination 10. other patients who are judged to be inappropriate as subjects 11. Those who may have conflicts of interest such as relatives of the principal investigator and collaborators of this study.
	Age Minimum	60age old over
	Age Maximum	84age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Vestibular disease
Intervention(s)		noisy galvanic vestibular stimulation (nGVS)
Health Condition(s) Keyword		dizziness
Intervention(s) Keyword		Galvanic stimulation
Health Condition(s) Code		C09-30-150-20+
Intervention(s) Code		E02-600-20
Primary Outcome(s)		Comparison of the Normalized Ratio of the total length of the posturography immediately after the stimulation of nGVS
Secondary Outcome(s)		(1) Comparison of the Normalized Ratio (NR) of the area and RMS of the posturography immediately after the stimulation of nGVS (2) Comparison of the NR of the total length, area, and RMS of the posturography, during and immediately after 30 minutes of stimulation of nGVS. (3) Comparison of the NR of the total length, area, and RMS of the posturography, during and immediately after 1 hour of stimulation of nGVS. (4) Comparison of the NR of the total length, area, and RMS of the posturography, at 30 minitus, 1 hour, and 3 hours after the end of stimulation of nGVS. (5) Adverse events

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Nagoya City University Certified Review Board
Address	1,Kawasumi,Mizuhocho,Mizuhoku,Nagoya,Aichi, Aichi
Telephone	+81-52-853-8346
E-Mail	rinshou-kenkyu@med.nagoya-cu.ac.jp
Approval Status	Approval
Date of approval	May. 29, 2024

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	April. 24, 2025	(this page)	Changes
2	Aug. 19, 2024	Detail	Changes
1	June. 12, 2024	Detail

List of change history