UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028916 |
|---|---|
| Receipt number | R000031824 |
| Scientific Title | The effectiveness of post tetanic stimulation for Br-SCEP |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2020/03/20 08:00:35 |
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Basic information
Public title
The effectiveness of post tetanic stimulation for Br-SCEP
Acronym
Does post tetanic stimulation facilitate Br-SCEP?
Scientific Title
The effectiveness of post tetanic stimulation for Br-SCEP
Scientific Title:Acronym
Does post tetanic stimulation facilitate Br-SCEP?
Region
| Japan |
Condition
Condition
cervical mylopathy, thoracic mylopathy
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Spinal cord monitoring is important. The purpose of this study is to clarify whether the post tetanic stimulation can augment D waveor not.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
latency of D wave
amplitude of D wave
Key secondary outcomes
Latency of CMAPs
Amplitude of CMAPs
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
tetanic stimulation to bilateral tibia nerves or bilateral median nerves before transcranial stimulation.
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
cervical spondylotic mylopathy
cervical OPLL
Thoracic OPLL
intradural extra medullary tumor
thoracic disc herniation
Key exclusion criteria
1) cases with brain disease
2) cases of re-operation
3) cases of infection
4) cases under 19 years
5) refused cases
6) cases with previous convulsive
7) cases using anticonvulsant agent
8) cases with pace maker
9) cases with metal plate in body
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Shigematsu |
Organization
Nara medical university
Division name
Dept. of Orthop. Surg.
Zip code
6348522
Address
Kashihara city Nara
TEL
+81744223051
shideki714@gmail.com
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Shigematsu |
Organization
Nara Medical University
Division name
Dept. of Orthop. Surg.
Zip code
6348522
Address
840 Shijyocho Kashihara Nara
TEL
0744-22-3051
Homepage URL
shideki714@gmail.com
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Nara Medical University
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
Nara Medical University
Address
Kashihara city Nara
Tel
0744-22-3051
hayakawa@naramed-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
| 2017 | Year | 09 | 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
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 30 | Day |
Last modified on
| 2020 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031824
