Safety assessment of a sub-scalp electroencephalography monitor

Not Applicable

Active, not recruiting

• Conditions: Epilepsy; Neurological - Epilepsy

• Registration Number: ACTRN12619001587190
• Lead Sponsor: Epi-Minder Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-19
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

1. Subject is aged between 18 and 75.
2. Subject speaks and reads English.
3. Established clinical diagnosis of focal or generalised epilepsy as defined by the ILAE (International League Against Epilepsy) criteria.
4. Subject and/or caregiver reports a minimum of two clinically identifiable epileptic events per month.
5. Subject can reasonably be expected to maintain a seizure diary and seizure monitoring device alone, or with the assistance of a competent individual.
6. Subject able to complete regular study visits and telephone appointments in accordance with the study protocol requirements.
7. A female subject must have a negative pregnancy test within two weeks prior to implant, and, if sexually active, must be using a reliable form of birth control, be surgically sterile, or be at least two years post-menopausal. Undertake serum pregnancy test at enrolment. If the negative serum pregnancy test result exceeds the two-week limit, then a negative result from a urine pregnancy kit within two weeks of implant is needed.

Exclusion Criteria

1. Subjects with significant progressive disorders or unstable medical conditions requiring acute intervention.
2. Active Vagus Nerve Stimulation (VNS), Deep Brain Stimulation (DBS), Responsive Neurostimulator System (RNS) or other neurostimulation device implanted for epilepsy or other conditions (e.g. cochlear implants).
3. Epilepsy surgery within 6 months prior to enrolment
6. A serious psychiatric disorder including unstable depression or where changes in pharmacotherapy are needed or anticipated during the study.
7. Subjects ineligible for device implantation surgery.
8. Subjects anticipated to have or with a high likelihood to have the following contraindicated treatments during the study: Magnetic Resonance Imaging (MRI), Electro-Convulsive Therapy (ECT), lithotripsy and diathermy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified