UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037315 |
|---|---|
| Receipt number | R000042544 |
| Scientific Title | Efficacy of transcranial direct current stimulation (tDCS) on the treatment of neurological diseases |
| Date of disclosure of the study information | 2019/07/09 |
| Last modified on | 2022/01/11 10:30:09 |
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Basic information
Public title
Efficacy of transcranial direct current stimulation (tDCS) on the treatment of neurological diseases
Acronym
Efficacy of transcranial direct current stimulation (tDCS) on the treatment of neurological diseases
Scientific Title
Efficacy of transcranial direct current stimulation (tDCS) on the treatment of neurological diseases
Scientific Title:Acronym
Efficacy of transcranial direct current stimulation (tDCS) on the treatment of neurological diseases
Region
| Japan |
Condition
Condition
multiple sclerosis, NMOSD, Parkinsonism, brain infarction
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy of tDCS on the cognitive impairment, motor dysfunction, and dysphagia of neurological diseases
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of cognitive impairment before and after tDCS treatment
Key secondary outcomes
Assessment of motor dysfunction before and after tDCS treatment
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
ten times tDCS during 2 weeks
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients in our hospital with multiple sclerosis, NMOSD, Parkinsonism, spinocerebellar degeneration, and brain infarction
Key exclusion criteria
Patients with magnetic medical devices such as pace maker and brain aneurysm clip
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Nakatsuji |
Organization
Toyama University Hospital
Division name
Department of Neurology
Zip code
930-0194
Address
2630 Sugitani, Toyama
TEL
076-434-7309
nakatsuj@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Konishi |
Organization
Toyama University Hospital
Division name
Department of Neurology
Zip code
930-0194
Address
2630 Sugitani, Toyama
TEL
076-434-7309
Homepage URL
koni16@med.u-toyama.ac.jp
Sponsor or person
Institute
Toyama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toyama University Hospital
Address
2630 Sugitani, Toyama
Tel
076-434-7309
nakatsuj@med.u-toyama.ac.jp
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
| 2019 | Year | 07 | Month | 09 | 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
Completed
Date of protocol fixation
| 2018 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 10 | Month | 18 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 09 | Day |
Last modified on
| 2022 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042544
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
