UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055411 |
|---|---|
| Receipt number | R000063319 |
| Scientific Title | Efficacy of low-frequency therapy in patients with drug-resistant refractory epilepsy |
| Date of disclosure of the study information | 2024/09/04 |
| Last modified on | 2025/03/05 12:43:21 |
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Basic information
Public title
Efficacy of low-frequency therapy in patients with drug-resistant refractory epilepsy
Acronym
Efficacy of low-frequency therapy in patients with drug-resistant refractory epilepsy
Scientific Title
Efficacy of low-frequency therapy in patients with drug-resistant refractory epilepsy
Scientific Title:Acronym
Efficacy of low-frequency therapy in patients with drug-resistant refractory epilepsy
Region
| Japan |
Condition
Condition
epilepsy
Classification by specialty
| Neurology | Pediatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
In this study, clinically diagnosed patients with refractory epilepsy who are refractory to drugs will undergo taVNS using a noninvasive low-frequency therapy device that is covered by insurance for painful conditions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage reduction in the frequency of seizures per week during the observation period and duration of infrasound treatment compared to the previous observation period
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Percentage reduction in the frequency of seizures per week during the observation period and duration of infrasound treatment compared to the previous observation period
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
| 6 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
atients who meet all of the following criteria are eligible
(i) Male and female patients who are at least 6 years old and less than 60 years old at the time of obtaining consent.
(ii) Patients who have been diagnosed with refractory epilepsy based on clinical seizure symptoms, electrophysiological tests, and course of treatment.
(iii) Patients who have received sufficient explanation for participation in this study, and who have given their or their surrogate's free and voluntary written consent after fully understanding the consent explanation document and assent document.
(iv) Persons who have at least one focal seizure (focal seizure with impairment of consciousness, focal seizure without impairment of consciousness, or focal onset bilateral tonic-clonic seizure) each week despite treatment with two or more antiepileptic drugs.
Key exclusion criteria
Patients with any one of the following conditions shall be excluded
(i) Patients with a history of progressive brain lesions
(2) Patients receiving concomitant vagus nerve stimulation therapy
(iii) Pregnant or lactating mothers
(iv) Patients with skin hypersensitivity and a history of skin symptoms caused by metal or other substances
(5) Patients who are abstinent or unable to use effective contraceptive methods during the period of participation in the study
(vi) Patients who have difficulty in oral intake
(vii) Patients with severe renal dysfunction (creatinine clearance less than 30 ml/min)
(viii) Other subjects deemed inappropriate as research subjects by the principal investigator or subinvestigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Egawa |
Organization
Hokkaido University Hospital
Division name
pediatrics
Zip code
060-8648
Address
Hokkaido University Hospital Kita14, Nishi5, Kita-Ku, Sapporo Hokkaido
TEL
0117161161
yu1.kojima@pop.med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Kojima |
Organization
Hokkaido Univesity Hospital
Division name
Respiratory
Zip code
060-8648
Address
Hokkaido University Hospital Kita14, Nishi5, Kita-Ku, Sapporo Hokkaido
TEL
0117161161
Homepage URL
yu1.kojima@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido Univesity
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
Kita14, Nishi5, Kita-Ku, Sapporo
Tel
011-706-7934
recjimu@huhp.hokudai.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
| 2024 | Year | 09 | Month | 04 | 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
| 2024 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 04 | Day |
Last modified on
| 2025 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063319
