UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032651 |
|---|---|
| Receipt number | R000037209 |
| Scientific Title | Monophasic transcranial constant-current versus constant-voltage stimulation of motor-evoked potentials during spinal surgery |
| Date of disclosure of the study information | 2018/05/21 |
| Last modified on | 2018/05/20 17:08:57 |
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Basic information
Public title
Monophasic transcranial constant-current versus constant-voltage stimulation of motor-evoked potentials during spinal surgery
Acronym
Comparison between constant current and constant voltage stimulations
Scientific Title
Monophasic transcranial constant-current versus constant-voltage stimulation of motor-evoked potentials during spinal surgery
Scientific Title:Acronym
Comparison between constant current and constant voltage stimulations
Region
| Japan |
Condition
Condition
spine surgery cases
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Constant-voltage and constant-current stimulators may be used for transcranial electrical stimulation of motor evoked potentials (TES-MEP). However, no previous reports have determined whether the two monophasic stimulation methods lead to similar responses during intra-operative monitoring. We studied differences in the literalities of compound muscle action potentials (CMAPs) during intra-operative spinal cord monitoring via TES-MEP using monophasic constant-current and constant-voltage stimulations.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We used two monophasic stimulation patterns. In pattern 1, we placed the anode and cathode on the right and left sides, respectively, and in pattern 2, we did the opposite . For each patient, we used both constant-voltage and constant-current stimulators with both stimulation patterns, for four conditions in total. We recorded baseline CMAPs in the first trial after the effects of rocuronium had disappeared. We applied the four conditions in random order. The interval between CMAP recordings was at least 2 min to avoid residual effects from the previous stimulation. TES-MEP recordings were considered successful when the recorded amplitudes of CMAPs were greater than 50 microV.
We also calculated the delivered charge. The delivered charge was fixed for the constant-current cases at 200 micro C (=200 (mA) * 0.2 (msec) * 5 (pulse stimulation train)). Meanwhile, we calculated the delivered charge for the constant-voltage cases: the delivered charge (microC)= ## (mA) * 0.05 (msec) *5 (pulse stimulation train). Because it was difficult to standardize the degree of stimulation between constant-current and constant-voltage stimulations, we calculated the efficiency, the value of which was wave amplitude for each muscle divided by the delivered charge, to standardize the obtained data from constant-current and constant-voltage stimulations.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
During spine surgery, transcranial electrical stimulation-compound muscle active potential with constant current stimulations
Interventions/Control_2
transcranial electrical stimulation-compound muscle active potential with constant voltage stimulations
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
the patients which underwent spine surgery with intraspinal cord monitoring and agreed with our clinical trial
Key exclusion criteria
the patients which underwent spine surgery without intraspinal cord monitoring and disagreed with our clinical trial
Target sample size
95
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Shigematsu |
Organization
Nara medical university
Division name
Orthopaedic surgery
Zip code
Address
840 shijo-cho Kashihara city Nara
TEL
0744223051
shideki714@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Shigematsu |
Organization
Nara Medical University
Division name
Orthopaedic surgery
Zip code
Address
840 Shijo-cho Kashihara city
TEL
0744223051
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
Address
Tel
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
| 2018 | Year | 05 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2014 | Year | 06 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 20 | Day |
Last modified on
| 2018 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037209
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