UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057773 |
|---|---|
| Receipt number | R000066026 |
| Scientific Title | The function of the sensory nerve is evaluated using an electric device to disturb a peripheral trigeminal nerve. |
| Date of disclosure of the study information | 2025/05/05 |
| Last modified on | 2025/05/04 13:40:03 |
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Basic information
Public title
The sensory nerve's function is evaluated using an electric device for the disturbance of a peripheral trigeminal nerve.
Acronym
The function of the sensory nerve is evaluated using an electric device to disturb a peripheral trigeminal nerve.
Scientific Title
The function of the sensory nerve is evaluated using an electric device to disturb a peripheral trigeminal nerve.
Scientific Title:Acronym
The function of the sensory nerve is evaluated using an electric device to disturb a peripheral trigeminal nerve.
Region
| Japan |
Condition
Condition
The disturbance of the peripheral trigeminal nerve
Classification by specialty
| Oral surgery | Plastic surgery | Dental medicine |
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the research is the diagnosis of the function of the peripheral nerve, using some methods for evaluation. And then, according to observing the process of recovery of the nerves, we evaluate the outcome and expect how recovery is the function of nerve-investigating treatment for nerve disterbance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We evaluated the degree of nerve disturbance using subjective examinations and a sensory nerve action potential for detecting the disturbance in patients who had nerve disturbance and visited our hospital.
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
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
We diagnose the degree of nerve disturbance using subjective and objective examinations.
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
| 16 | years-old | <= |
Age-upper limit
| 116 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The study includes patients over 16 years old who had a peripheral nerve disturbance.
Key exclusion criteria
The study excluded patients with no peripheral nerve disturbance symptoms, and we couldn't obtain the patients' agreement with this study.
Target sample size
750
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Katakura |
Organization
Tokyo Dental College
Division name
Oral Pathobiological Science and Surgery
Zip code
101-0061
Address
2-9-18 Kanda-Misaki-Cho Chiyoda-Ku Tokyo
TEL
0363809246
katakura@tdc.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Katakura |
Organization
Tokyo Dental College
Division name
Oral Pathobiological Science and Surgery
Zip code
1010061
Address
2-9-18 Kandamisakicho Chiyoda-ku Tokyo
TEL
03-5275-1725
Homepage URL
https://www.tdc.ac.jp/college/information/tabid/209/Default.aspx
katakura@tdc.ac.jp
Sponsor or person
Institute
Tokyo Dental College
Institute
Department
Personal name
Funding Source
Organization
Tokyo Dental College
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
The ethics committee of Tokyo Dental College
Address
2-9-18 Kanda-Misaki cho Chiyoda-Ku Tokyo
Tel
03-6380-9114
drinri@tdc.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
| 2025 | Year | 05 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 09 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 04 | Day |
Last modified on
| 2025 | Year | 05 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066026
