FEASIBILITY STUDY USING ELECTRODES

Zusammenfassung der Studie

To support his patients living with epilepsy, the neurologist needs to continuously monitor and measure epileptic seizures. Indeed, seizures are unpredictable and sometimes very frequent. For neurologists, it was therefore necessary to be able to detect any seizure both day and night through continuous measurement of the EEG (electroencephalogram). To meet this medical need, researchers have developed implantable devices that allow this continuous EEG monitoring. These devices being implanted in the skull, a less invasive monitoring system is desirable, hence it involves measuring the EEG by placing electrodes under the scalp without penetrating the skull. These EPIOS electrodes slipped under the scalp allow for continuous measurement of the patients' EEG. To demonstrate the feasibility of this system, we have set up a 4-step program. In this first submission, only the first 2 steps will be applied. Step 1 will include patients undergoing craniotomy, with or without intraoperative EEG recording, that is, monitoring during the surgical intervention, as routinely practiced in the neuro-surgery operating room. Step 2 will include patients with epilepsy who need to undergo craniotomy for the implantation of intracranial electrodes as prescribed by their neurologist. These patients will therefore undergo a more invasive surgical procedure than that proposed in the study, thus increasing the chances of participation and decreasing the risks associated with the study intervention. Moreover, since intracranial EEG studies generally last between 1 and 2 weeks, this duration is sufficient to test the quality and stability of the recordings with the new electrodes slipped under the scalp.

(BASEC)

Untersuchte Intervention

Step 2:

The placement of EPIOS electrodes under the scalp occurs during the intracranial surgery that the patient must undergo for clinical reasons. The EPIOS electrodes remain in place under the scalp for a duration varying from 1 to 3 weeks depending on the duration prescribed by the neurologist for the clinical intracranial electrodes. At the end of this prescribed period, the clinical electrodes and the study electrodes are explanted.

The patient will not have any additional postoperative monitoring other than that prescribed for the clinical electrodes.

During these postoperative monitoring sessions, the controlled clinical data will be:

• a brain CT at 24 hours,

• neurological monitoring every hour for 36 hours,

• regular laboratory analyses as indicated by the neurologist,

• an inspection of the scalp and incisions at 48 to 72 hours,

• an initial pain assessment every hour, then daily until the patient's discharge,

• EEG monitoring for the study of seizures and exclusion of the epileptic state.

For steps 1 and 2, the surgical procedure of the study will be the same for the included patients. Each patient will receive EPIOS electrodes specifically designed for this study. The EPIOS electrodes will be slipped under the scalp, 1 to 15 insertions will be made under the skin of the skull over a length varying from 5 to 12 cm. The inserted probes are between 5 and 12 cm long and will have between 1 and 8 electrodes. The insertion is performed using a cannula and a stylet specifically designed for the insertion of EPIOS electrodes.

For step 1, the inserted probes remain in place for 1 minute.

For step 2, the inserted probes remain in place for a duration of 1 to 3 weeks depending on the neurologist's prescription regarding the clinical intracranial electrodes, and until the explantation of these.

(BASEC)

Untersuchte Krankheit(en)

epilepsy

(BASEC)

Sponsor

nicht verfügbar

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Bern

(BASEC)

Datum der Bewilligung durch die Ethikkommission

09.03.2021

(BASEC)

Ergebnisse der Studie