Early Feasibility Study on Epios Leads

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 toolkits and have been designed for continuous EEG recording in inpatients.

This clinical investigation is part of a stepwise program to validate the entire Epios system and it starts with the validation of the Epios leads alone in this two steps study.

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Device: Subcutaneous implantation of Epios sub-scalp leads

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-reporting. However, it is now established that self-reports of seizure burdens are inaccurate. The reasons for this are multiple, but important ones include the fact that seizures can affect brain regions involved in awareness and memory, and that epilepsy patient can also have persistent cognitive deficits, so they do not recall having a seizure. EEG caps are the standard tool for monitoring brain waves, but this technology is typically used for less than an hour and rarely can be managed for a period of a week or so because of the need for continual technical interventions, like reapplying electrodes to the skin. Thus, there is no way to fill the gap in the ability to obtain monitoring of EEG for weeks, months or longer.

Given the unmet need for the objective monitoring of epileptic seizures in ambulatory patients, innovative solutions are under development.

The Epios device under investigation in this study consists in novel sub-scalp leads implanted between the scalp and the skull through an insertion tunneling toolkit for EEG monitoring in short-term conditions.

This clinical investigation is part of a stepwise program to validate the entire Epios system and it starts with the validation of the Epios leads alone in step 1 and step 2.

Step 1 is an intra-operative step only, where a 10-minute long EEG recording is performed using the Epios leads, after the patient has undergone general anesthesia for his/her clinically-indicated brain surgery. The study material is removed before skin closure and end of anesthesia.

Step 2 is an inpatient, short-term step, where, following clinically-indicated surgery for brain electrode implantation, the participants will stay in a continuous care unit. Clinical care and study recordings (with Epios subscalp leads) will be carried out in parallel. The Epios leads will remain implanted for the same length of time as the clinical electrodes: clinical EEG workups in epilepsy last one week at the clinical trial hospital, rarely two weeks, virtually never longer. In adherence to this approach, the implantation period of the investigational electrode in step 2 will be less than twenty one days (< 21 days).

Steps 1 and 2 will take 12 to 18 months in total. First participant-In is planned in January 2021 for step 1 and last participant-In is planned in July 2022.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3007
    • Universitätklinik für Neurologie, Inselspital, Bern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single-arm; Implantation of subcutaneous leads and connection to an external EEG amplifier	Device: Subcutaneous implantation of Epios sub-scalp leads; The sub-scalp Epios Leads will be implanted by a trained neurosurgeon and will provide epicranial EEG recording of specific cortical areas identified by the neurologist.; Other Names: Subcutaneous Epios leads insertion through tunneling toolkit with tear-away sheath

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of inserting Epios Leads in step 1	The primary outcome of step 1 is to assess the feasibility of inserting two different EEG electrode leads (tubular and flat) under the human scalp via the tunneling tools. Measurement parameter: Length of each incision measured in centimeters.	Through the length of Step 1, up to 24 weeks
Feasibility of inserting Epios Leads in step 2	The primary outcome of step 2 is to assess the feasibility of inserting Leads tridents (either tubular or flat depending on the outcome from step 1) under the human scalp via the tunneling tools. Measurement parameter: Length of each incision measured in millimeters.	Through the length of Step 2 , up to 1 year
Safety assessed as number of adverse events related to study device compared to the total number of adverse events for Step 1	Patients' safety monitoring is ensured along the clinical study in a descriptive manner. Safety criteria resulting or not in early device explantation have been established to monitor patients' safety.	Through the length of Step 1, up to 24 weeks
Safety assessed as number of adverse events related to study device compared to the total number of adverse events for Step 2	Patients' safety monitoring is ensured along the clinical study in a descriptive manner. Safety criteria resulting or not in early device explantation have been established to monitor patients' safety.	Through the length of Step 2 , up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Capability of tubular leads to record subscalp EEG signals in Step 1	The investigator will compare the absolute amplitude and derive a power spectrum to identify the power distribution in each recording.	Through the length of Step 1, up to 24 weeks
Capability of flat leads to record subscalp EEG signals in Step 1	The investigator will compare the absolute amplitude and derive a power spectrum to identify the power distribution in each recording.	Through the length of Step 1, up to 24 weeks
Capability of Epios leads to record epileptiform EEG signals from the sub-scalp space in Step 2	The investigator will compare power spectra in different electrodes from sub-scalp and intracranial EEG. Measurement parameter: Signal-to-Noise Ratio (SNR) analysis for the subcutaneous electrodes leads compared to intracranial electrodes.	Through the length of Step 2 , up to 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative surgical feedback on the handling of the two EEG lead designs in Step 1	Measurement Parameters: Questionnaires: Insertion tunneling toolkit (tear-away sheaths and stylets) used (yes/no choice); Number of tear-away sheaths used (open field); Number of stylets used (open field)	Immediately after each single implantation and final assessment after 24 weeks
Qualitative comparison of EEG recordings between the two leads designs in Step 1	Measurement Parameter: Questionnaires	Immediately after each single implantation and final assessment after 24 weeks
Qualitative comparison to parallel scalp and intracranial EEG in Step 2	Measurement parameter: Questionnaires	Up to 21 days
Quantitative comparison to parallel scalp and intracranial EEG in Step 2	Comparison of power spectra in different electrodes from subscalp and intracranial EEG. Measurement parameter: Signal-to-Noise Ratio (SNR) analysis for the subcutaneous electrodes leads compared to intracranial electrodes.	Up to 21 days
Calculation of number of false negatives in expert detection of seizures in sub-scalp EEG in Step 2		Through the length of Step 2 , up to 1 year
Collection of clinical pain assessment in Step 2	Descriptive pain perception on a scale from 0 ( no pain) to 10 (pain max). Numeric rating scales (NRS) is used.	Through the length of Step 2 , up to 1 year

Collaborators and Investigators

• Sponsor: Wyss Center for Bio and Neuroengineering
• Investigators: Principal Investigator: Maxime Baud, MD, PhD, Universitätklinik für Neurologie, Inselspital, Bern University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2021
• Primary Completion (Actual): July 7, 2023
• Study Completion (Actual): November 2, 2023

Study Registration Dates

• First Submitted: December 18, 2020
• First Submitted That Met QC Criteria: March 11, 2021
• First Posted (Actual): March 15, 2021

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: Epios

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No