Drug-resistant epilepsy as defined in the Epilepsy Clinical Practice Guidelines 2018 Drug-resistant epilepsy
Conditions
Interventions
In this study, SEEG procedures are defined, and tests are performed with uniform accuracy at each site.
Sponsors
IIDA KOJI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Epilepsy patients between 2 and 90 years of age 2. Patients diagnosed with drug-resistant epilepsy as defined in the Epilepsy Clinical Practice Guidelines 2018, for whom non-invasive testing cannot accurately identify the epileptogenic zones (EZs) and SEEG is considered necessary 3. Patient is able to complete the required research protocol follow-up and the patient or legally authorized representative is willing to do so 4. Patients who are able (and willing) to sign an informed consent form approved by Certified Review Board (CRB) (including patients whose legally authorized representative provides written informed consent)
Exclusion criteria
Exclusion criteria: 1. Patients has any condition which would in the judgment of the Investigator, would place the patient at undue risk or interfere with the investigation by participation in the study 2. Patients with signs of infection at or near the site of the proposed electrode insertion 3. Patient is alcohol or drug abusers, and/or anticipated to be non-compliant with instructions 4. Patients with neurological disorders that make them uncooperative or unable to follow instructions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seizure-free rate from 2 weeks to 12 months postoperatively after resective surgery for the epileptogenic zones (EZs) identified in SEEG. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints in SEEG are: A) For the SEEG evaluation population, the following items are evaluated -Focal diagnosis rate (calculation of the percentage of cases in which SEEG was performed that resulted in a focal diagnosis): evaluated by surgical records and monitoring results. Surgical efficiency (calculated from the time from patient entry to exit from the operating room and from time-out to the end of the last electrode placement): evaluated by surgical records. Placement accuracy (calculated from the difference between the pre-SEEG planning and the actual position of the implanted electrode): evaluated by the surgical record, postoperative CT, and adverse event reports (the error measurement between the preoperatively planned electrode implantation position and the actual implantation position using CT images will be evaluated by the central evaluator). ) -Rate of transition from diagnosis of epileptogenic zones (EZs) to resection of epileptogenic zones (EZs) by SEEG (resection transition rate) -Rate of transition from diagnosis of epileptogenic zones (EZs) to ablative surgery of epileptogenic zones (EZs) by SEEG (ablative surgery transition rate) Secondary endpoints in the resective (curative) surgery will be B) The following items will be evaluated in the population that underwent SEEG and underwent resective surgery in the epileptogenic zones (EZs). - Epileptogenic zones (EZs) resective surgery outcome: assessed by clinical evaluation, IQ evaluation and electroencephalography (up to 24 months postoperatively) -Quality of life of study subjects: assessed by QOLIE-AD-48 or QOLIE-31-P (up to 24 months postoperatively) -Comparison of planned and actual resection areas in focal area resective surgery: evaluated by MRI (up to 24 months postoperatively) -Changes in concomitant medications/adjunctive therapies related to epilepsy treatment: assessed by concomitant medications/adjunctive therapies (up to 24 months postoperatively) -Rate of adverse events | — |
Contacts
Public ContactKOJI IIDA
Hiroshima University Hospital
Outcome results
None listed