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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032651
Receipt No. 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

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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
Email 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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037209

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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