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Early Feasibility Study on Epios Leads

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ClinicalTrials.gov Identifier: NCT04796597
Recruitment Status : Recruiting
First Posted : March 15, 2021
Last Update Posted : March 30, 2021
Sponsor:
Information provided by (Responsible Party):
Wyss Center for Bio and Neuroengineering

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 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.


Condition or disease Intervention/treatment Phase
Epilepsy Device: Subcutaneous implantation of Epios sub-scalp leads Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Early Feasibility Study on Epios Leads
Actual Study Start Date : March 23, 2021
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

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 Name: Subcutaneous Epios leads insertion through tunneling toolkit with tear-away sheath




Primary Outcome Measures :
  1. Feasibility of inserting Epios Leads in step 1 [ Time Frame: Through the length of Step 1, up to 24 weeks ]

    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.


  2. Feasibility of inserting Epios Leads in step 2 [ Time Frame: Through the length of Step 2 , up to 1 year ]

    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.


  3. Safety assessed as number of adverse events related to study device compared to the total number of adverse events for Step 1 [ Time Frame: Through the length of Step 1, up to 24 weeks ]
    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.

  4. Safety assessed as number of adverse events related to study device compared to the total number of adverse events for Step 2 [ Time Frame: Through the length of Step 2 , up to 1 year ]
    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.


Secondary Outcome Measures :
  1. Capability of tubular leads to record subscalp EEG signals in Step 1 [ Time Frame: Through the length of Step 1, up to 24 weeks ]
    The investigator will compare the absolute amplitude and derive a power spectrum to identify the power distribution in each recording.

  2. Capability of flat leads to record subscalp EEG signals in Step 1 [ Time Frame: Through the length of Step 1, up to 24 weeks ]
    The investigator will compare the absolute amplitude and derive a power spectrum to identify the power distribution in each recording.

  3. Capability of Epios leads to record epileptiform EEG signals from the sub-scalp space in Step 2 [ Time Frame: Through the length of Step 2 , up to 1 year ]

    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.



Other Outcome Measures:
  1. Qualitative surgical feedback on the handling of the two EEG lead designs in Step 1 [ Time Frame: Immediately after each single implantation and final assessment after 24 weeks ]

    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)

  2. Qualitative comparison of EEG recordings between the two leads designs in Step 1 [ Time Frame: Immediately after each single implantation and final assessment after 24 weeks ]

    Measurement Parameter:

    Questionnaires


  3. Qualitative comparison to parallel scalp and intracranial EEG in Step 2 [ Time Frame: Up to 21 days ]

    Measurement parameter:

    Questionnaires


  4. Quantitative comparison to parallel scalp and intracranial EEG in Step 2 [ Time Frame: Up to 21 days ]

    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.


  5. Calculation of number of false negatives in expert detection of seizures in sub-scalp EEG in Step 2 [ Time Frame: Through the length of Step 2 , up to 1 year ]
  6. Collection of clinical pain assessment in Step 2 [ Time Frame: Through the length of Step 2 , up to 1 year ]
    Descriptive pain perception on a scale from 0 ( no pain) to 10 (pain max). Numeric rating scales (NRS) is used.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04796597


Contacts
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Contact: Maxime Baud, MD, PhD +41 (0)79 385 9690 maxime.baud.neuro@gmail.com

Locations
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Switzerland
Universitätklinik für Neurologie, Inselspital, Bern University Recruiting
Bern, Switzerland, 3007
Contact: Maxime Baud, MD    +41 (0)79 385 9690    maxime.baud.neuro@gmail.com   
Sponsors and Collaborators
Wyss Center for Bio and Neuroengineering
Investigators
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Principal Investigator: Maxime Baud, MD, PhD Universitätklinik für Neurologie, Inselspital, Bern University Hospital
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Responsible Party: Wyss Center for Bio and Neuroengineering
ClinicalTrials.gov Identifier: NCT04796597    
Other Study ID Numbers: Epios
First Posted: March 15, 2021    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases