UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006267 |
|---|---|
| Receipt number | R000007405 |
| Scientific Title | Development of an artificial neural connection device for neurorehabilitation |
| Date of disclosure of the study information | 2011/09/01 |
| Last modified on | 2020/09/22 21:03:28 |
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Basic information
Public title
Development of an artificial neural connection device for neurorehabilitation
Acronym
Development of an artificial neural connection device for neurorehabilitation
Scientific Title
Development of an artificial neural connection device for neurorehabilitation
Scientific Title:Acronym
Development of an artificial neural connection device for neurorehabilitation
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of therapy for motor functional recovery by building artificial neural connections with magnetic stimulation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
motor function, electromyography
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Activity dependent simultaneous spinal and cutaneous stimulation
Interventions/Control_2
Activity dependent spinal stimulation
Interventions/Control_3
Activity dependent cutaneous stimulation
Interventions/Control_4
Activity independent spinal stimulation
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
healty adults, who give written informed consent after detailed explanation of the study
Key exclusion criteria
history of psychiatric disease, severe head trauma, history of brain surgery, epilepsy, cardiac arrhythmia, implanted cardiac pace maker, deep brain stimulation device, insulin pump or wires, pregnancy
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yoshikazu |
| Middle name | |
| Last name | Ugawa |
Organization
Fukushima Medical University
Division name
Department of Neurology
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima, Japan
TEL
+81-24-547-1248
ugawa-tky@umin.net
Public contact
Name of contact person
| 1st name | Suguru |
| Middle name | |
| Last name | Kadowaki |
Organization
Fukushima Medical University
Division name
Department of Neurology
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima, Japan
TEL
+81-24-547-1248
Homepage URL
skado@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University, School of Medicine, Department of Neurology
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Division of Behavioral Development, Department of Developmental Physiology, National Institute for Physiological Sciences
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Fukushima Medical University
Address
1 Hikarigaoka, Fukushima, Japan
Tel
+81-24-547-1825
rs@fmu.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
| 2011 | Year | 09 | Month | 01 | 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
10
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
| 2011 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 10 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 10 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 10 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 01 | Day |
Last modified on
| 2020 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007405
