Robot assisted SEEG for Epilepsy patient in Japan Study (ROSE-J Study)

JRCT ID: jRCTs062240079

Registered date:08/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Drug-resistant epilepsy as defined in the Epilepsy Clinical Practice Guidelines 2018
• Date of first enrollment: 08/11/2024
• Target sample size: 150
• Study type: Interventional
• Intervention(s): In this study, SEEG procedures are defined, and tests are performed with uniform accuracy at each site.

Outcome(s)

• Primary Outcome: Seizure-free rate from 2 weeks to 12 months postoperatively after resective surgery for the epileptogenic zones (EZs) identified in SEEG.

Secondary Outcome

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). )

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 transition from diagnosis of epileptogenic zones (EZs) to resection of epileptogenic zones (EZs) by SEEG (resection transition rate)

Secondary endpoints in the ablative surgery will be B) The following items will be evaluated in the population that underwent SEEG and underwent ablative surgery in the epileptogenic zones (EZs).
- Epileptogenic zones (EZs) ablative 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 ablation areas in focal area ablative 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 transition from diagnosis of epileptogenic zones (EZs) to ablative surgery of epileptogenic zones (EZs) by SEEG (ablative surgery transition rate)

The safety evaluations will be performed as below.
Safety of the investigational device: A) frequency and incidence of adverse events in the SEEG evaluation population.
Overall safety of the study: D) Evaluated by frequency and incidence of adverse events in the safety evaluation population.

Key inclusion & exclusion criteria

• Age minimum: >= 2age old
• Age maximum: < 90age old
• Gender: Both

Include 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 legal 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 legal representative provides written informed consent)

Exclude 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

Related Information

• Primary Sponsor: IIDA KOJI
• Source(s) of Monetary Support: Zimmer Biomet G.K.