UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059304 |
|---|---|
| Receipt number | R000067827 |
| Scientific Title | Analysis of Local Field Potentials Using SEEG and DBS in Refractory Epilepsy and Movement Disorders |
| Date of disclosure of the study information | 2025/10/06 |
| Last modified on | 2025/10/06 13:56:31 |
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Basic information
Public title
Analysis of Local Field Potentials Using SEEG and DBS in Refractory Epilepsy and Movement Disorders
Acronym
Analysis of Local Field Potentials Using SEEG and DBS in Refractory Epilepsy and Movement Disorders
Scientific Title
Analysis of Local Field Potentials Using SEEG and DBS in Refractory Epilepsy and Movement Disorders
Scientific Title:Acronym
Analysis of Local Field Potentials Using SEEG and DBS in Refractory Epilepsy and Movement Disorders
Region
| Japan |
Condition
Condition
refractory epilepsy, parkinson's disease, essential tremor, dystonia
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Objective of the Study:
To obtain and analyze local field potential (LFP) data recorded from intracranial electrodes implanted during clinically indicated procedures in patients with drug-resistant epilepsy or neurological disorders accompanied by movement abnormalities, in order to gain new insights.
Basic objectives2
Others
Basic objectives -Others
Objective of the Study:
To obtain and analyze local field potential (LFP) data recorded from intracranial electrodes implanted during clinically indicated procedures in patients with drug-resistant epilepsy or neurological disorders accompanied by movement abnormalities, in order to gain new insights.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary Outcome Measures (and Their Indicators / Evaluation Methods):
To examine the relationship between electrophysiological activity at individual electrodes or functional connectivity across multiple brain regions and postoperative outcomes, including seizure control and improvement in motor symptoms. EEG/LFP data obtained from the implanted electrodes will be analyzed offline to assess correlations with clinical data.
Key secondary outcomes
Secondary Outcome Measures (and Their Indicators, Evaluation Methods):
Accuracy of electrode implantation, to be evaluated using patient's medical records and imaging data.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with drug-resistant epilepsy or movement disorders, including Parkinson's disease, essential tremor, or dystonia, who are indicated for intracranial electrode implantation at the Department of Neurosurgery, Keio University School of Medicine.
Patients who provide written informed consent to participate in this study. For minors or adults with insufficient decision-making capacity, written consent will be obtained from their legally authorized representative.
Key exclusion criteria
Patients who develop severe postoperative complications following electrode implantation.
Patients deemed by the principal investigator or co-investigators to be unsuitable for participation in this study for any other reason.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kenzo |
| Middle name | |
| Last name | Kosugi |
Organization
Keio University Hospital
Division name
Department of Neurosurgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
kensan03977@keio.jp
Public contact
Name of contact person
| 1st name | Kenzo |
| Middle name | |
| Last name | Kosugi |
Organization
Keio University Hospital
Division name
Department of Neurosurgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
kensan03977@keio.jp
Sponsor or person
Institute
Keio University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-3353-1211
kensan03977@keio.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 | 10 | Month | 06 | 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 | 10 | Month | 29 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 29 | Day |
Last follow-up date
| 2034 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2025 | Year | 10 | Month | 06 | Day |
Last modified on
| 2025 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067827
