UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014885 |
|---|---|
| Receipt number | R000016226 |
| Scientific Title | Study of repetitive periphery sensory nerve electric stimulation for sensory disturbance in central nervous system disorder. |
| Date of disclosure of the study information | 2014/08/19 |
| Last modified on | 2019/06/11 14:47:53 |
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Basic information
Public title
Study of repetitive periphery sensory nerve electric stimulation for sensory disturbance in central nervous system disorder.
Acronym
Effect of repetitive peripheral sensory nerve stimulation for sensory disturbance in stroke patients.
Scientific Title
Study of repetitive periphery sensory nerve electric stimulation for sensory disturbance in central nervous system disorder.
Scientific Title:Acronym
Effect of repetitive peripheral sensory nerve stimulation for sensory disturbance in stroke patients.
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the feasibility of repetitive peripheral sensory nerve stimulation for sensory disturbance in stroke patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Semmes Weinstein Monofilaments test, Moberg's pick up test
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
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Training for sensory disorder combined with sensory nereve electrical stimulation
Interventions/Control_2
Training for sensory disorder
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Sensory disorders caused by single stroke (onset >6 months), normal consciousness with stable medical and neulogical status.
Key exclusion criteria
The patient that a disorder was not able to understand study contents.the patient having dermatosis at an electrode patch position.The patient whom pacemaker is buried in.In addition, we exclude the patient who judged that a doctor has difficulty with this study participation.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kentaro Kobayashi |
Organization
Jikei University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
Address
3-19-18 Nishishinbashi Tokyo, Minato-ku, Japan
TEL
03-3433-1111
kobakent0319@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kentaro Kobayashi |
Organization
Jikei University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
Address
3-19-18 Nishishinbashi Tokyo, Minato-ku, Japan
TEL
03-3433-1111
Homepage URL
kobakent0319@yahoo.co.jp
Sponsor or person
Institute
Jikei University School of Medicine
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東京慈恵会医科大学付属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 19 | 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
| 2012 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2012 | Year | 12 | Month | 11 | Day |
Last follow-up date
| 2019 | 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
| 2014 | Year | 08 | Month | 18 | Day |
Last modified on
| 2019 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016226
