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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045642
Receipt No. R000052050
Scientific Title A prospective observational study on organ regulation by vagus nerve stimulation
Date of disclosure of the study information 2021/10/02
Last modified on 2021/10/02

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Basic information
Public title A prospective observational study on organ regulation by vagus nerve stimulation
Acronym A prospective observational study on organ regulation by vagus nerve stimulation
Scientific Title A prospective observational study on organ regulation by vagus nerve stimulation
Scientific Title:Acronym A prospective observational study on organ regulation by vagus nerve stimulation
Region
Japan

Condition
Condition Epilepsy
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the effects of vagus nerve stimulation on abdominal organs and autonomic nervous system.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Changes in C-peptide levels before and 1 year after implantation of vagus nerve stimulator
Key secondary outcomes Increase in C-peptide levels at 6 months and 2 years after vagus nerve stimulation, changes in glucose tolerance test, glucagon test, urinary C-peptide, continuous glucose, ECG R-R interval coefficient of variation, InBody, and blood samples at each evaluation time point.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
3 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients with epilepsy that do not fully respond to anti-epileptic drugs and need a vagus nerve stimulator implantation.
Key exclusion criteria (1) Patients who cannot measure scheduled test items.
(2) Patients who are unable to visit the outpatient clinic for follow-up.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name KUNIYASU
Middle name
Last name NIIZUMA
Organization Tohoku University Graduate School of Medicine
Division name Department of Neurosurgical Engineering and Translational Neuroscience
Zip code 980-8575
Address 2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL 022-717-7230
Email niizuma@nsg.med.tohoku.ac.jp

Public contact
Name of contact person
1st name SHINICHIRO
Middle name
Last name OSAWA
Organization Tohoku University Graduate School of Medicine
Division name Department of Neurosurgery
Zip code 980-8574
Address 2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan
TEL 022-717-7230
Homepage URL
Email osawa@nsg.med.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Research Institute for Electronic Science, Hokkaido University
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Committee Tohoku University Graduate School of Medicine
Address 2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
Tel 022-717-7321
Email med-kenkyo@grp.tohoku.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
2021 Year 10 Month 02 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 Preinitiation
Date of protocol fixation
2021 Year 09 Month 15 Day
Date of IRB
2021 Year 09 Month 27 Day
Anticipated trial start date
2021 Year 10 Month 11 Day
Last follow-up date
2028 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We will examine the effects of vagus nerve stimulation on glucose metabolism and autonomic nerve function in patients undergoing vagus nerve stimulator implantation by measuring the following items before the start of stimulation (at the time of hospitalization for surgery), 6 months (plus or minus 2 weeks), 1 year (plus or minus 4 weeks), and 2 years (plus or minus 6 weeks) after stimulation.

<Measurement items>
general blood sampling, height, weight, vital signs, ECG (ECG R-R interval coefficient of variation, which is a measure of autonomic function, will be calculated from the ECG performed as a routine examination during hospitalization), clinical symptoms, and stimulator settings, glucagon tolerance test, blood glucose level, blood insulin, blood C-peptide, and InBody. Glucose tolerance test, urinary C-peptide, continuous blood glucose monitoring are also performed.

Management information
Registered date
2021 Year 10 Month 02 Day
Last modified on
2021 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052050

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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