UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051488 |
|---|---|
| Receipt number | R000058697 |
| Scientific Title | Elucidation of the neurophysiological mechanisms of vagus nerve stimulation |
| Date of disclosure of the study information | 2023/06/30 |
| Last modified on | 2023/06/30 13:35:04 |
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Basic information
Public title
Elucidation of the neurophysiological mechanisms of vagus nerve stimulation
Acronym
Elucidation of the neurophysiological mechanisms of vagus nerve stimulation
Scientific Title
Elucidation of the neurophysiological mechanisms of vagus nerve stimulation
Scientific Title:Acronym
Elucidating the Mechanisms of vagus nerve stimulation
Region
| Japan |
Condition
Condition
Epilepsy, Parkinson's disease
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will elucidate the mechanism of the effect of transcranial vagus nerve stimulation by investigating changes in neural activity induced by vagus nerve stimulation using a combination of noninvasive and invasive brain activity measurements and cognitive testing.
Basic objectives2
Others
Basic objectives -Others
1. investigation of changes in neural activity during vagus nerve stimulation, 2. investigation of the relationship between the results of neural activity measurements during taVNS stimulation and the degree of symptom improvement with invasive vagus nerve stimulation therapy, 3. investigation of changes in cognitive function associated with modulation of autonomic neural activity by vagus nerve stimulation.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Differences in brain activity (BOLD signal intensity in cortical and subcortical regions) at rest and during cognitive tasks during taVNS stimulation will be compared between epileptic patients and healthy controls.
Key secondary outcomes
Brain activity (BOLD signal intensity and local potentials) at rest and during cognitive task loading were compared before and during taVNS stimulation using functional timing image resonance and local potential measurements.
The results of behavioral indices of cognitive tasks are compared before and during taVNS stimulation.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Presentation of taVNS (up to 1 day in healthy adults and epilepsy group, up to 5 days in patients with implanted electrodes)
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Epileptic patients. Normal adults. For normal adults, patients between the ages of 18-65 years with no diagnosed congenital or developmental disorders. Patients with refractory epilepsy who will undergo intracranial electrode placement to identify the epileptic focal area. Patients with Parkinson's disease, dystonia, essential tremor, stroke-induced movement disorder, stroke aftereffects, or involuntary movement disorder who are undergoing deep brain stimulation therapy to relieve symptoms of the above diseases.
Key exclusion criteria
Exclusion criteria for patients and healthy adults undergoing functional magnetic resonance imaging testing
1. people who have a pacemaker implanted in their body.
2. people who have metal in their body for surgery or drug injection.
3. people who may have accidentally received a piece of metal in their body from working in the metal processing industry, etc.
4. people who are claustrophobic.
5. People who experience severe shortness of breath when lying down.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kensuke |
| Middle name | |
| Last name | Kawai |
Organization
Jichi Medical University
Division name
Department of neurosurgery
Zip code
3290498
Address
3311-1 Yakushiji, Shimotsuke, Tochigi, Japan
TEL
0285-58-7373
kenkawai-tky@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Kensuke |
| Middle name | |
| Last name | Kawai |
Organization
Jichi Medical University
Division name
Department of Neurosurgery
Zip code
329-0498
Address
3311-1, Yakushiji, Shimotsuke, Tochigi
TEL
0285-58-7373
Homepage URL
kenkawai-tky@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
(Grants-in-Aid for Scientific Research)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jichi Medical University
Address
3311-1, Yakushiji, Shimotsuke, Tochigi
Tel
0285-58-7576
rinri@jichi.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
自治医科大学脳神経外科、東京大学
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 30 | 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
| 2023 | Year | 01 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 30 | Day |
Last modified on
| 2023 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058697
