UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057909 |
|---|---|
| Receipt number | R000066194 |
| Scientific Title | A Multicenter Retrospective Study of Treatment Outcomes and Prognostic Factors for Stereotactic Radiofrequency Thermal Coagulation (RFTC) for Drug-Resistant Focal Epilepsy |
| Date of disclosure of the study information | 2025/05/20 |
| Last modified on | 2025/05/19 16:53:53 |
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Basic information
Public title
A Multicenter Retrospective Study of Treatment Outcomes and Prognostic Factors for Stereotactic Radiofrequency Thermal Coagulation (RFTC) for Drug-Resistant Focal Epilepsy
Acronym
A Multicenter Retrospective Study of Stereotactic Radiofrequency Thermal Coagulation (RFTC) for Drug-Resistant Epilepsy
Scientific Title
A Multicenter Retrospective Study of Treatment Outcomes and Prognostic Factors for Stereotactic Radiofrequency Thermal Coagulation (RFTC) for Drug-Resistant Focal Epilepsy
Scientific Title:Acronym
A Multicenter Retrospective Study of Stereotactic Radiofrequency Thermal Coagulation (RFTC) for Drug-Resistant Epilepsy
Region
| Japan |
Condition
Condition
Drug-resistant epilepsy
Classification by specialty
| Neurology | Pediatrics | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will elucidate treatment outcomes of stereotactic radiofrequency thermal coagulation (RFTC) for drug-resistant focal epilepsy and the preoperative factors associated with these outcomes. As a preliminary step to validate the efficacy of RFTC compared to standard therapy, the goal is to define an appropriate patient population and build a foundation for more successful future clinical trials.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Seizure outcomes at one year after surgery
Key secondary outcomes
Seizure outcome at last follow-up, Surgery-related complications, Acute and chronic postoperative complications, Planned treatment area, Target volume, Resulting volume, Coagulation ratio, Number of ablations, Number of brain punctures, Etiology of epilepsy, Treatment sites
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
| 2 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Diagnosis of drug-resistant focal epilepsy
2. Patients how underwent stereotactic radiofrequency thermocoagulation for the treatment of drug-resistant focal epilepsy and had at least one-year postoperative follow-up
3. Aged 2 years or older, and younger than 70 years
Key exclusion criteria
none
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Iwasaki |
Organization
National Center Hospital, National Center of Neurology and Psychiatry
Division name
Neurosurgery
Zip code
187-8551
Address
4-1-1 Ogawahigashi-cho, Kodaira, Tokyo
TEL
+81-42-341-2711
iwa@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Iwasaki |
Organization
National Center Hospital, National Center of Neurology and Psychiatry
Division name
Neurosurgery
Zip code
187-8551
Address
4-1-1 Ogawahigashi-cho, Kodaira, Tokyo
TEL
+81-42-341-2711
Homepage URL
iwa@ncnp.go.jp
Sponsor or person
Institute
National Cener of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
National Center of Neurology and Psychiatry
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
National Center of Neurology and Psychiatry
Address
4-1-1 Ogawahigashi-cho, Kodaira, Tokyo
Tel
+81-42-341-2711
rinrijimu@ncnp.go.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 | 20 | 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
| 2025 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2029 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Information will be collected on the following items for the tests and evaluations performed.
Preoperative examination:
(1) Basic patient demographics, Epilepsy type, Seizure type, Etiology of epilepsy, Seizure frequency, Medical history
(2) Neuropsychological tests: intellectual, memory, developmental index
(3) Brain MRI, anonymized imaging data
(4) FDG-PET, anonymized image data
(5) Functional MRI diagnosis
(6) Long-term video-EEG monitoring: seizure symptoms, interictal epileptiform discharges, and ictal epileptiform discharges
(7) Magnetoencephalography findings
(8) Intracranial EEG: technique (subdural electrodes, SEEG), seizure onset zone, distribution of interictal epileptiform discharges, findings of functional mapping
Treatment (RFTC) information:
(1) Planned treatment area (epileptogenic area), volume of planned treatment area
(2) Software used for treatment planning
(3) Equipment used for treatment
(4) Number of punctures planned, number of coagulations, total volume of coagulations
(5) Number of punctures performed, number of coagulations, extent of treatment, surgical technique (skin incision, craniotomy)
(6) Surgical complications
Outcome information:
(1) Seizures and complications during the acute postoperative period (1 week)
(2) Seizure outcome (ILAE classification), complications, brain MRI, anonymized imaging data after 1, 3, 6 months of treatment
(3) Seizure outcome, complications, date of seizure recurrence, antiepileptic drugs, and neuropsychological examination after 1 year of treatment
(4) Treatment extent and volume on MRI after 1 year of treatment, anonymized imaging data
(5) Seizure outcome and complications after 2 years of treatment
(6) Seizure outcome, complications, antiepileptic drugs, and follow-up period at the last follow-up
To identify postoperative seizure outcome and complications. To examine the relationship between etiology, treatment volume, treatment rate of lesions, treatment site and seizure outcome.
Management information
Registered date
| 2025 | Year | 05 | Month | 19 | Day |
Last modified on
| 2025 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066194
