UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021536 |
|---|---|
| Receipt number | R000024830 |
| Scientific Title | Development of the new rehabilitation approach for equilibrium function combined by transcranial direct current stimulation over the cerebllum |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2018/03/20 09:31:57 |
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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
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
satokogane@gmail.com
Sponsor or person
Institute
Kyoto university
Institute
Department
Personal name
Funding Source
Organization
Research grant
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
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
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
Date of closure to data entry
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024830
