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

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 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

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

Value
https://center6.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