Subcutaneous EEG in Epilepsy

Subcutaneous EEG in Epilepsy - Proof of Concept and Clinical Applications

The study is a two-phase study, which aims to explore the uses of a novel electrode type in detecting epileptic seizures. The electrode is designed for subcutaneous implantation with long-term monitoring in mind.

Study Overview

• Status: Completed
• Conditions: Temporal Lobe Epilepsy
• Intervention / Treatment: Device: UNEEG implantable EEG electrode and data storage device

Detailed Description

The problem of unrecognized seizures is common for certain types of epilepsy. Electroencephalography (EEG) is an excellent method for seizure identification and recognition, but until now, it has not been feasible to perform EEG recordings for more than a few days outside a hospital or laboratory. A novel device has been developed, which might remedy that. The device is a EEG-electrode for subcutaneous implantation connected to an external data storage device.

The investigators in this study hypothesize that this device might be a useful tool for ultra-long-term epilepsy monitoring. The study aims to investigate that. While the device might be used to diagnose epilepsy, it is more likely to be a good seizure counting tool and that is what the study aims to determine.

Subjects include patients with mesial temporal lobe epilepsy and high seizure frequency. These will have the device implanted. Study phase 1 is a proof of concept to determine whether the device is actually able to detect epileptic seizures. This will take place during admission and be performed as simultaneous recordings with ordinary scalp EEG and the investigational device. Study phase 2 is a home monitoring to prove that devices actually provides clinically useful information regarding seizures in an outpatient setting.

The study requires 9 visits from each subject over the course of 4-6 months. The investigational device will be explanted after approximately 75 days of wear.

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

Contacts and Locations

Study Locations

• Denmark
  • Roskilde, Denmark, 4000
    • Zealand University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Semiology of some seizures compatible with mesial temporal lobe involvement.

2. Paraclinical findings supporting mesial temporal seizure focus. Such proof may consist of:

   • previous EEG recording interpreted as compatible with mesial temporal involvement OR
   • radiological findings demonstrating pathology in the mesial temporal area (CT, MRI, FDG-PET or SPECT).
3. Age 18-90.
4. Current seizure frequency (fulfilling criteria 1) of more than one per week to be eligible to EMU admission or 1 per month for direct enrollment to home monitoring (by own account).
5. Available for the duration of the study (6 months from screening).

Exclusion Criteria:

1. Known disorder of hemostasis.

2. Daily or frequent (more than 2 days per week) treatment with any drugs of the following types:

   • antiplatelets
   • anticoagulants
   • chemotherapeutics
   • non-steroid anti-inflammatory drugs (NSAID)
   • omega 3 fatty acids (fish oil)
3. Skeletal deformities or damage at the proposed implantation site to an extent that impedes correct electrode placement.
4. Scheduled facial or cranial surgery within 6 months from enrollment.
5. Active deep brain stimulation device.
6. Presence of implanted ICD pacemaker, cochlear implant or other active implants.
7. Planned transcranial magnetic stimulation (TMS) or transcranial direct current stimulation (tDCS) in the duration of the study.
8. Presence of any implanted device at the proposed site of implantation.
9. Known allergy towards any material that is part of the investigational device.
10. Females of childbearing potential who are pregnant, intend to become pregnant, or are not using adequate contraceptive methods throughout the study.
11. Performing extreme sport, including scuba diving (snorkel diving is allowed), parachute jumping or martial arts.
12. Scheduled MRI within 5 months from enrollment.
13. Work involving operation of MRI-scanner.
14. Operating hand held transceivers for communication (e.g. within the police, medical, fire, air traffic control, marine or military).
15. Working at broadcast stations for television or FM/DAB radio.
16. Known or suspected abuse of alcohol defined as estimated consumption beyond that, which is recommended by the DHA or any other neuro-active substances.
17. Active vagus nerve stimulator.
18. Skin disorders near the proposed implantation site, including infection.
19. Contraindications against the local anesthetic drug used during im- and explantation.
20. Diabetes of any kind.

21. Psychiatric disorders including:

    • schizophrenia
    • bipolar affective disorder
    • emotionally unstable personality disorder
    • schizoaffective disorder
    • schizotypal disorder
    • autism

22. Severely abnormal paraclinical findings or vital signs:

    • S-creatinine ≥ 3 times upper reference value
    • ALAT, alkaline phosphatase or bilirubin≥ 3 times upper reference value
    • APTT > 50 seconds
    • thrombocyte count < 50 or >1000 x 10^9/l
    • INR ≥ 1,6
    • HgBA1C > 55 mmol/mol
    • Any ECG finding requiring immediate referral to a cardiologist as assessed by the investigator
    • pulse <40 bpm or >120 bpm or suspicion of atrial fibrillation by auscultation
    • temperature >38 ºC
    • respiration rate >30 pr. minute
    • systolic blood pressure < 80 mmHg or >220 mmHg and diastolic blood pressure <50 mmHg or >120 mmHg
    • any other clinical or paraclinical finding suggesting known or unknown illness or disorder requiring immediate treatment as assessed by the investigator

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Implantation; Implantation of a subcutaneous electrode and connection to the external logging device	Device: UNEEG implantable EEG electrode and data storage device; The implantable EEG electrode will be implanted subcutaneously in the relevant temporal region by a certified neurosurgeon. The EEGgraphical data recorded will be transmitted transcutaneously to the data storage device via an inductive link, providing continuous data on brain activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seizure comparison	Qualitative comparison of patient-recorded seizures and EEGgraphical seizures	24 months
Adverse events	Descriptive account of device related adverse events	24 months
Compliance	Descriptive account of compliance in use of the investigational device	24 months

Collaborators and Investigators

• Sponsor: Zealand University Hospital
• Collaborators: UNEEG Medical A/S; Technical University of Denmark
• Investigators: Principal Investigator: Troels Kjær, Professor, Zealand University Hospital

Publications and helpful links

General Publications

• Gangstad SW, Mikkelsen KB, Kidmose P, Tabar YR, Weisdorf S, Lauritzen MH, Hemmsen MC, Hansen LK, Kjaer TW, Duun-Henriksen J. Automatic sleep stage classification based on subcutaneous EEG in patients with epilepsy. Biomed Eng Online. 2019 Oct 30;18(1):106. doi: 10.1186/s12938-019-0725-3.

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): January 23, 2019
• Study Completion (Actual): February 11, 2019

Study Registration Dates

• First Submitted: October 19, 2016
• First Submitted That Met QC Criteria: October 24, 2016
• First Posted (Estimate): October 27, 2016

Study Record Updates

• Last Update Posted (Actual): May 8, 2019
• Last Update Submitted That Met QC Criteria: May 6, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Epilepsy; Electroencephalography; Seizure monitoring
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes; Epilepsies, Partial; Epilepsy; Epilepsy, Temporal Lobe
• Other Study ID Numbers: 2016IL01; CIV-16-05-015704 (Other Identifier: EUDAMED)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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