Early Feasibility Study on Epios Leads

NCT04796597 | Completed DMC

• 1 other identifier: Epios
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Capability of tubular leads to record subscalp EEG signals in Step 1

  Through the length of Step 1, up to 24 weeks

• Capability of flat leads to record subscalp EEG signals in Step 1

  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

  Through the length of Step 2 , up to 1 year

Other Outcomes (6)

• Qualitative surgical feedback on the handling of the two EEG lead designs in Step 1

  Immediately after each single implantation and final assessment after 24 weeks

• Qualitative comparison of EEG recordings between the two leads designs in Step 1

  Immediately after each single implantation and final assessment after 24 weeks

• Qualitative comparison to parallel scalp and intracranial EEG in Step 2

  Up to 21 days

Study Arms (1)

Single-arm

EXPERIMENTAL

Implantation of subcutaneous leads and connection to an external EEG amplifier

Device: Subcutaneous implantation of Epios sub-scalp leads

Interventions

Subcutaneous implantation of Epios sub-scalp leads DEVICE

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.

Also known as: Subcutaneous Epios leads insertion through tunneling toolkit with tear-away sheath

Single-arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wyss Center for Bio and Neuroengineering: lead

Study Sites (1)

Universitätklinik für Neurologie, Inselspital, Bern University

Bern, 3007, Switzerland

Location

Related Publications (1)

• van Maren E, Alnes SL, Ramos da Cruz J, Sobolewski A, Friedrichs-Maeder C, Wohler K, Barlatey SL, Feruglio S, Fuchs M, Vlachos I, Zimmermann J, Bertolote T, Z'Graggen WJ, Tzovara A, Donoghue J, Kouvas G, Schindler K, Pollo C, Baud MO. Feasibility, Safety, and Performance of Full-Head Subscalp EEG Using Minimally Invasive Electrode Implantation. Neurology. 2024 Jun 25;102(12):e209428. doi: 10.1212/WNL.0000000000209428. Epub 2024 Jun 6.

  PMID: 38843489 DERIVED

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Maxime Baud, MD, PhD

  Universitätklinik für Neurologie, Inselspital, Bern University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: March 15, 2021
• Study Start: March 23, 2021
• Primary Completion: July 7, 2023
• Study Completion: November 2, 2023
• Last Updated: November 14, 2023

Record last verified: 2023-11

Locations

CH (1)