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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
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 | 2020/03/20 |
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 |
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Condition | ||
Condition | cervical mylopathy, thoracic mylopathy | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | cervical spondylotic mylopathy
cervical OPLL Thoracic OPLL intradural extra medullary tumor thoracic disc herniation |
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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 |
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Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |