Status:
COMPLETED
Early Feasibility Study on Epios Leads
Lead Sponsor:
Wyss Center for Bio and Neuroengineering
Conditions:
Epilepsy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The Epios early feasibility study aims to explore the uses of novel sub-scalp lead devices in the detection of epileptic seizures. Epios leads are inserted subcutaneously through dedicated tunneling t...
Detailed Description
According to the state of the art, epilepsy is defined as the spontaneous recurrence of seizures at random intervals. When epilepsy is drug refractory, management plans rely entirely on seizure self-r...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age ≥ 18 years
- Informed Consent as documented by signature
- Neurosurgical patient, i.e. patient under surgical care who will undergo one of the following specific procedures:
- Step 1: Patient in the operating room undergoing clinically indicated brain surgery either for resection (e.g. tumor), cortical mapping (including awake) or intracranial electrode implantation
- Step 2: patients with pharmaco-resistant epilepsy hospitalized in the epilepsy monitoring unit (EMU) for the purpose of intracranial EEG monitoring
- Exclusion Criteria:
- Patients with increased risk of infection
- Pregnant or breast-feeding women
- Severe neuropsychiatric disorders
- Severe cognitive problems: the patients need to be able to understand instructions and provide consent
- Chronic headache disorders, such as migraine and related disorders, as well as trigeminal neuralgia
- Medical conditions contraindicating cranial surgery (e.g. skin disorders causing poor wound healing, blood or cardiac disorder requiring chronic anti-coagulation, osteomyelitis, active systemic infection, haemorrhagic disease, diabetes, hepatitis, any documented allergy to implantation material)
- Other chronic, unstable medical conditions that could interfere with subject participation
- Existing scalp lesions or skin breakdown
- Scalp infections
- Implanted neurosurgical devices that are incompatible with Epios leads, which may include DBS leads
- Subjects who are allergic to the anaesthetics used in the implantation
Exclusion
Key Trial Info
Start Date :
March 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04796597
Start Date
March 23 2021
End Date
November 2 2023
Last Update
November 14 2023
Active Locations (1)
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1
Universitätklinik für Neurologie, Inselspital, Bern University
Bern, Switzerland, 3007