UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047998 |
|---|---|
| Receipt number | R000049685 |
| Scientific Title | Intraoperative motor evoked potential amplification effect of tetanic stimulation in pediatric craniotomy |
| Date of disclosure of the study information | 2022/06/09 |
| Last modified on | 2024/12/09 12:27:14 |
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Basic information
Public title
Intraoperative motor evoked potential amplification effect of tetanic stimulation in pediatric craniotomy
Acronym
Intraoperative motor evoked potential amplification effect of tetanic stimulation in pediatric craniotomy
Scientific Title
Intraoperative motor evoked potential amplification effect of tetanic stimulation in pediatric craniotomy
Scientific Title:Acronym
Intraoperative motor evoked potential amplification effect of tetanic stimulation in pediatric craniotomy
Region
| Japan |
Condition
Condition
Pediatric craniotomy cases
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the MEP detection rate and amplitude enhancement effect of pudendal nerve tetanus stimulation in pediatric craniotomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection rate and amplitude in transcranial and direct stimulation MEP.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Before performing surgical manipulation in craniotomy, MEP is measured as a baseline for neuromonitoring. Then, MEP is measured by peripheral nerve tetanus stimulation of the extremities, and finally, MEP is measured by adding pudendal nerve tetanus 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
| Not applicable |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients under 15 years of age requiring craniotomy.
Key exclusion criteria
Patients with pacemaker implants.
Allergic to metals or adhesives in electrodes.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Sasaki |
Organization
Nara Medical University
Division name
Neurosurgery
Zip code
6348521
Address
840, Shijo-cho, Kashihara-shi, Nara, Japan
TEL
0744223051
ryotasasaki2601@gmail.com
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Sasaki |
Organization
Nara Medical University
Division name
Neurosurgery
Zip code
6348521
Address
840, Shijo-cho, Kashihara-shi, Nara, Japan
TEL
0744223051
Homepage URL
ryotasasaki2601@gmail.com
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara Medical University
Address
840, Shijo-cho, Kashihara-shi, Nara, Japan
Tel
0744223051
ryotasasaki2601@gmail.com
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
| 2022 | Year | 06 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
An analysis of 15 cases was published in a paper.
1. Sasaki R, Tamura K, Yamazaki S, Kim TK, Takatani T, Hayashi H, Motoyama Y, Nakagawa I, Park YS, Kawaguchi M, Nakase H. Effects of intraoperative motor evoked potential amplification following tetanic stimulation of the pudendal nerve in pediatric craniotomy. J Neurosurg Pediatr. 2023 Feb 24;31(5):488-495. doi: 10.3171/2023.1.PEDS22505.
2. Sasaki R, Tamura K, Kim TK, Takatani T, Nakagawa I, Park YS, Nakase H. Tetanic Stimulation of the Pudendal Nerve Amplifies Intraoperative Motor Evoked Potential in Pediatric Craniotomy. World Neurosurg. 2023 Jun;174:227-228. doi: 10.1016/j.wneu.2023.03.071.
3. Sasaki R, Tamura K, Takatani T, Park YS, Nakagawa I. Intraoperative motor-evoked potential with tetanic stimulation changes pre- and post-hemispherotomy. Childs Nerv Syst. 2023 Oct 3. doi: 10.1007/s00381-023-06170-1.
4. Sasaki R, Kim TK, Takatani T, Park YS, Nakagawa I. Transcranial motor-evoked potentials disappear with pons transection. Childs Nerv Syst. 2024 Nov;40(11):3879-3883. doi: 10.1007/s00381-024-06575-6.
Management information
Registered date
| 2022 | Year | 06 | Month | 08 | Day |
Last modified on
| 2024 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049685
