Endovascular EEG Device single-arm clinical trial to confirm efficacy and safety performance on Intractable Epilepsy patients

JRCT ID: jRCT2032230720

Registered date:20/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients with intractable epilepsy undergoing intracranial electrode placement
• Date of first enrollment: 28/03/2024
• Target sample size: 37
• Study type: Interventional
• Intervention(s): EP-01 is placed through the left and right jugular veins. The device will be indwelled only once, and after the occurrence of epileptic seizures is confirmed during indwelling, the EP-01 itself will be removed at the discretion of the investigator or sub-investigator. If no seizures are confirmed, the device will be left in place for up to 2 weeks (allowance + 3 days) and then removed.

Outcome(s)

• Primary Outcome: Ability to diagnose laterality of epileptic focus using EP-01

Secondary Outcome

(1)Ability to diagnose laterality of epilepsy focus using EP-01 only
(2)EEG identification of waveforms using EP-01
(3)Ability to diagnose laterality of epileptic focus using EP-01(Concordance rate with diagnostic results from intracranial electrodes placed on both sides)
(4)Epilepsy seizure freedom rate 1 year after focal resection
(5)EP-01 placement success rate (%)
(6)Evaluation of Safety and defects

Key inclusion & exclusion criteria

• Age minimum: >= 15age old
• Age maximum: < 70age old
• Gender: Both

Include criteria

Patients who meet all of the following criteria are eligible.
(1) Among patients with intractable epilepsy, patients with temporal lobe epilepsy, frontal lobe epilepsy, parietal lobe epilepsy, occipital lobe epilepsy, and insular gyrus epilepsy
(2) Patients with intracranial electrode placement
(3) Patients with vascular anatomy that allows EP-01 to be guided into the brain from the jugular veins on both sides into vessels close to the epilepsy focus, such as the cavernous sinus, transverse sinus, superior sagittal sinus, and inferior petrosal sinus.(The placement of the indwelling blood vessel in the main body of EP-01 is at the discretion of the physician. However, it must be confirmed that it can be guided to symmetrical positions on both sides of the cerebral veins.)
(4) Over 15 years old and under 70 years old (at the time of obtaining consent)

Exclude criteria

Subjects who do not meet any of the following criteria will be excluded and will not be eligible for this study.
(1)Epilepsy patients with only generalized seizures
(2)Patients with occlusion/thrombus in the internal jugular vein
(3)Patients with bleeding diathesis and coagulation disorders
(4)Patients who have difficulty staying calm during surgery
(5)Patients with severe contrast agent allergy
(6)Patients with metal allergies
(7)Patients who are pregnant or may become pregnant
(8)Patients participating in other clinical trials
(9)Other patients who are judged by the investigator or sub-investigator to be inappropriate to participate in this study

Related Information

• Primary Sponsor: Matsumaru Yuji