UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044806 |
|---|---|
| Receipt number | R000051173 |
| Scientific Title | Investigation of the effects of non-invasive brain stimulation on brain oscillations and plasticity |
| Date of disclosure of the study information | 2021/07/09 |
| Last modified on | 2025/04/02 07:26:24 |
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Basic information
Public title
Investigation of the effects of non-invasive brain stimulation on brain oscillations and plasticity
Acronym
Investigation of the effects of non-invasive brain stimulation on brain functions
Scientific Title
Investigation of the effects of non-invasive brain stimulation on brain oscillations and plasticity
Scientific Title:Acronym
Investigation of the effects of non-invasive brain stimulation on brain functions
Region
| Japan |
Condition
Condition
neurological diseases
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of non-invasive brain stimulation (NIBS) on brain oscillations and plasticity in the diseased brain
Basic objectives2
Others
Basic objectives -Others
To compare the effects of NIBS between the patients and healthy adults
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Neurological examinations (e.g. evoked potentials and EEG), neuroimagings, neurological examinations, and neurofunctional examinations (e.g. motor, swallowing, memory, cognition, behavior)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
non-invasive brain stimulation
Interventions/Control_2
sham 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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Generally good health without severe cardiovascular disease, severe malnutrition, or high fever
Key exclusion criteria
Pregnant
Hemodialysis patients
Presence of a metal implant in the head or spine
Presence of a pacemaker
An episode of a seizure within last one year
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Sumiya |
| Middle name | |
| Last name | Shibata |
Organization
Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata, Japan
TEL
025-257-4455
sumiya-shibata@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Sumiya |
| Middle name | |
| Last name | Shibata |
Organization
Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata, Japan
TEL
025-257-4455
Homepage URL
sumiya-shibata@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Suisyoukai Murata Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata, Japan
Tel
025-257-4455
rinri@nuhw.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
新潟医療福祉大学 (新潟県)
医療法人 穂翔会 村田病院 (大阪府)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
63
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
| 2021 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 09 | Day |
Last modified on
| 2025 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051173
