UMIN-CTR Clinical Trial

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
Email	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
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	Nara Medical University
Address	Kashihara city Nara
Tel	0744-22-3051
Email	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
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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