UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046426 |
|---|---|
| Receipt number | R000052844 |
| Scientific Title | Neurological evaluation of the effects of noninvasive brain stimulation on brain rhythms and brain plasticity in the pathological brain |
| Date of disclosure of the study information | 2021/12/21 |
| Last modified on | 2022/09/16 17:32:31 |
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Basic information
Public title
Neurological evaluation of the effects of noninvasive brain stimulation on brain rhythms and brain plasticity in the pathological brain
Acronym
Neurological Effects of Noninvasive Brain Stimulation
Scientific Title
Neurological evaluation of the effects of noninvasive brain stimulation on brain rhythms and brain plasticity in the pathological brain
Scientific Title:Acronym
Neurological Effects of Noninvasive Brain Stimulation
Region
| Japan |
Condition
Condition
cerebral neurological disease
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Before and during the intervention by transcranial electrical stimulation, transcranial static magnetic field stimulation, or a combination of the two, neuroscientific tests (evoked potentials by transcranial magnetic stimulation or peripheral nerve stimulation, electroencephalography, electromyography, imaging tests, etc.), physiological tests (electrocardiography, blood pressure and respiration tests, etc.), motor function assessment, memory assessment, cognitive function assessment, and behavioral assessment will be performed. The effects of peripheral nerve stimulation on brain rhythms and brain plasticity will be examined by comparing the effects in normal healthy subjects and patients with neurological diseases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intervention 1: Neuroscientific testing, physiological testing, and assessment of upper and lower extremity function, swallowing, memory, cognition, and behavior will be performed before and during transcranial electrical stimulation (20-30 minutes).
Intervention 2: Neuroscientific testing, physiology, upper and lower extremity function, swallowing, memory, cognition, and behavior will be assessed before and during a combination of transcranial electrical stimulation (10-30 minutes) and transcranial static magnetic field stimulation (10-30 minutes).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
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
| Maneuver |
Interventions/Control_1
Neuroscience, physiology, upper and lower extremity function, swallowing, memory, cognition, and behavioral assessments are combined with rehabilitation therapy including neuro-feedback of motor tasks, cognitive tasks, and brain activity before and during transcranial electrical stimulation (20-30 minutes) intervention.
Interventions/Control_2
Neuroscience, physiology, upper and lower limb function, swallowing, memory, cognition, and behavior are assessed before, during, and between interventions using a combination of transcranial electrical stimulation (10-30 minutes) and transcranial static magnetic field stimulation (10-30 minutes), including motor tasks, cognitive tasks, and neuro feedback of brain activity during stimulation. Rehabilitation therapy is used in combination.
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
Good general health.
Key exclusion criteria
Pregnant women
Dialysis patients
Metal in the cranium
Has a cardiac pacemaker
Has a spinal cord stimulator or other device
History of convulsive seizures in the past year
Target sample size
360
Research contact person
Name of lead principal investigator
| 1st name | Sachimori |
| Middle name | |
| Last name | Ichimura |
Organization
Murata hospital
Division name
Department of rehabilitation
Zip code
544-0011
Address
4-2-1 Tajima Ikuno-ku, Osaka-shi, Osaka-fu 544-0011 Japan
TEL
06-6757-0011
r.shimomura.1988@gmail.com
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Shimomura |
Organization
Murata hospital
Division name
Department of rehabilitation
Zip code
544-0011
Address
4-2-1 Tajima Ikuno-ku, Osaka-shi, Osaka-fu 544-0011 Japan
TEL
06-6757-0011
Homepage URL
r.shimomura.1988@gmail.com
Sponsor or person
Institute
Clinical Research Ethics Committee, Murata Hospital, Suisho-kai Medical Corporation
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Clinical Research Ethics Committee, Murata Hospital, Suisho-kai Medical Corporation
Address
4-2-1 Tajima Ikuno-ku, Osaka-shi, Osaka-fu 544-0011 Japan
Tel
06-6757-0011
reha@muratahospital.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2020-002
Org. issuing International ID_1
Clinical Research Ethics Committee, Murata Hospital, Suisho-kai Medical Corporation
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 21 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 14 | 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 | 12 | Month | 21 | Day |
Last modified on
| 2022 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052844
