UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037112 |
|---|---|
| Receipt number | R000042284 |
| Scientific Title | Modulation of motor control through the EEG-EMG neurofeedback strategy |
| Date of disclosure of the study information | 2019/07/01 |
| Last modified on | 2019/06/19 14:40:09 |
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Basic information
Public title
Rehabilitation approach by neurofeedback training
Acronym
The effect of Rehabilitation approach by neurofeedback training
Scientific Title
Modulation of motor control through the EEG-EMG neurofeedback strategy
Scientific Title:Acronym
EEG-EMG neurofeedback
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of neurofeedback system to modulate the central nervous system, and investigation of the effect of its modulated function.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EEG-EMG coherence and center of pressure in before and after intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) 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
Modulation of central nervous system using real-time neurofeedback system for 5 days
Interventions/Control_2
Feedback system using noisy information for 5 days
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
The inclusion criteria were physically active and independent; no history of any neurological, orthopedic, cognitive, or psychiatric problems that interfere with maintaining the postural balance.
Key exclusion criteria
The exclusion criteria were following:insert the metal into the body; taking medications (Depression etc); pregnant; subjects who are not suitable for this experiment
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ippei |
| Middle name | |
| Last name | Nojima |
Organization
Shinshu university
Division name
Health Science
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto-city, Nagano, Japan
TEL
0263-37-2408
nojima@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Ippei |
| Middle name | |
| Last name | Nojima |
Organization
Shinshu university
Division name
Health Science
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto-city, Nagano, Japan
TEL
0263-37-2408
Homepage URL
nojima@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu university
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Shinshu university
Address
3-1-1, Asahi, Matsumoto-city, Nagano, Japan
Tel
0263-37-2572
mdrinri@shinshu-u.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 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 06 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | 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
| 2019 | Year | 06 | Month | 19 | Day |
Last modified on
| 2019 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042284
