UMIN-CTR Clinical Trial

Basic information
Public title	Development of the new rehabilitation approach for equilibrium function combined by transcranial direct current stimulation over the cerebllum
Acronym	the rehabilitation for equilibrium function combined by tDCS
Scientific Title	Development of the new rehabilitation approach for equilibrium function combined by transcranial direct current stimulation over the cerebllum
Scientific Title:Acronym	the rehabilitation for equilibrium function combined by tDCS
Region	Japan

Condition
Condition	Equilibrium dysfunction
Classification by specialty	Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Rehabilitation for the equilibrium dysfunction is effective. The previous studies have been reported it by meta-analysis. However, on the other hand, although the relief of symptoms is obtained by the rehabilitation, about 30% of the patients continue to show the equilibrium dysfunction such as dizziness. In addition, remission is not obtained at all in 2% of the patients. For these patients, we need new techniques to enhance the effect of rehabilitation. Rehabilitation effects is brought by the motor learning in the cerebellum that enhance the new cerebellar vestibular nerve pathway or existing neural pathways. In the present study, we investigate whether rehabilitation for equilibrium dysfunction combined by tDCS over the cerebellum would be more effective compared to the rehabilitation alone.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Dizziness questionnaire (DHI), Mesurement of body sway, reaction time task, electromyogram evoked by TMS
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Cluster
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Rehabilitation combined by sham stimulation
Interventions/Control_2	Rehabilitation combined by tDCS
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with equilibrium dysfunction Healthy volunteers
Key exclusion criteria	Patients with epilepsy
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Satoko Koganemaru
Organization	Kyoto university
Division name	Human brain research center
Zip code
Address	Shogoin Kawahara-cho54, Sakyo-ku, Kyoto 606-8507, Japan
TEL	+81-75-751-3695
Email	satokogane@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Satoko Koganemaru
Organization	Kyoto university
Division name	Human brain research center
Zip code
Address	Shogoin Kawahara-cho54, Sakyo-ku, Kyoto 606-8507, Japan
TEL	+81-75-751-3695
Homepage URL
Email	satokogane@gmail.com

Sponsor
Institute	Kyoto university
Institute
Department

Funding Source
Organization	Research grant
Organization
Division
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Other related organizations
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IRB Contact (For public release)
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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	2016 Year 04 Month 01 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
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Results Delayed
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Baseline Characteristics
Participant flow
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Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 03 Month 18 Day
Date of IRB
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date
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Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 03 Month 18 Day
Last modified on	2018 Year 03 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024830

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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