UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015341
Receipt number R000017840
Scientific Title The elucidation and clinical application of vestibular stimulation effect on imbalance of the dementia patients
Date of disclosure of the study information 2014/10/05
Last modified on 2014/10/04 14:56:22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The elucidation and clinical application of vestibular stimulation effect on imbalance of the dementia patients

Acronym

Vestibular stimulation effect on dementia patients

Scientific Title

The elucidation and clinical application of vestibular stimulation effect on imbalance of the dementia patients

Scientific Title:Acronym

Vestibular stimulation effect on dementia patients

Region

Japan


Condition

Condition

Dementia

Classification by specialty

Medicine in general Neurology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The elucidation and clinical application of vestibular stimulation effect

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

caloric test

Key secondary outcomes



Base

Study type


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Dementia patients with vestibular stimulation

Interventions/Control_2

Dementia patients with no vestibular stimulation

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Dementia ( e.g. Alzheimer's disease, frontotemporal dementia, vascular dementia)

Key exclusion criteria

any previous outer or middle ear diseases
sarcopenia
antipsychotic agent remedy

Target sample size

75


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akira Tamaoka

Organization

Faculty of Medicine, University of Tsukuba

Division name

Department of Neurology, Division of Clinical Medicine

Zip code


Address

Tennoudai 1-1-1, Tsukuba, Ibaraki 305-8575, Japan

TEL

029-853-3224

Email

atamaoka@md.tsukuba.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kiyotaka Nakamagoe

Organization

Faculty of Medicine, University of Tsukuba

Division name

Department of Neurology, Division of Clinical Medicine

Zip code


Address

Tennoudai 1-1-1, Tsukuba, Ibaraki 305-8575, Japan

TEL

029-853-3224

Homepage URL


Email

Nakamagoek@md.tsukuba.ac.jp


Sponsor or person

Institute

University of Tsukuba Hosipital

Institute

Department

Personal name



Funding Source

Organization

Scientific Research (C) (No. 26460901) from the Ministry of Education, Culture, Sports, Science and Technology of Japan

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


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

2014 Year 10 Month 05 Day


Related information

URL releasing protocol


Publication of results

Unpublished


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

Preinitiation

Date of protocol fixation

2014 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 10 Month 06 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

2014 Year 10 Month 04 Day

Last modified on

2014 Year 10 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017840


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name