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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028916
Receipt No. 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 2018/12/04

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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
Middle name
Last name Hideki Shigematsu
Organization Nara medical university
Division name Dept. of Orthop. Surg.
Zip code
Address 840 Shijyocho Kashihara Nara
TEL 0744-22-3051
Email shideki714@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Hideki Shigematsu
Organization Nara Medical University
Division name Dept. of Orthop. Surg.
Zip code
Address 840 Shijyocho Kashihara Nara
TEL 0744-22-3051
Homepage URL
Email shideki714@gmail.com

Sponsor
Institute Nara Medical University
Institute
Department

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
Address
Tel
Email

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 Enrolling by invitation
Date of protocol fixation
2017 Year 08 Month 01 Day
Date of IRB
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
2018 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031824

Research Plan
Registered date File name
2017/08/31 久保田重松先生 新プロトコル Ver 4.docx

Research case data specifications
Registered date File name
2017/08/31 Case report form Ver 3.xlsx

Research case data
Registered date File name


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