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Subcutaneous EEG in Epilepsy

Primary Purpose

Temporal Lobe Epilepsy

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
UNEEG implantable EEG electrode and data storage device
Sponsored by
Zealand University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Temporal Lobe Epilepsy focused on measuring Epilepsy, Seizure monitoring, Electroencephalography

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zealand University hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Implantation

Arm Description

Implantation of a subcutaneous electrode and connection to the external logging device

Outcomes

Primary Outcome Measures

Seizure comparison
Qualitative comparison of patient-recorded seizures and EEGgraphical seizures
Adverse events
Descriptive account of device related adverse events
Compliance
Descriptive account of compliance in use of the investigational device

Secondary Outcome Measures

Full Information

First Posted
October 19, 2016
Last Updated
May 6, 2019
Sponsor
Zealand University Hospital
Collaborators
UNEEG Medical A/S, Technical University of Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT02946151
Brief Title
Subcutaneous EEG in Epilepsy
Official Title
Subcutaneous EEG in Epilepsy - Proof of Concept and Clinical Applications
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
January 23, 2019 (Actual)
Study Completion Date
February 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zealand University Hospital
Collaborators
UNEEG Medical A/S, Technical University of Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporal Lobe Epilepsy
Keywords
Epilepsy, Seizure monitoring, Electroencephalography

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Implantation
Arm Type
Experimental
Arm Description
Implantation of a subcutaneous electrode and connection to the external logging device
Intervention Type
Device
Intervention Name(s)
UNEEG implantable EEG electrode and data storage device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Seizure comparison
Description
Qualitative comparison of patient-recorded seizures and EEGgraphical seizures
Time Frame
24 months
Title
Adverse events
Description
Descriptive account of device related adverse events
Time Frame
24 months
Title
Compliance
Description
Descriptive account of compliance in use of the investigational device
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Semiology of some seizures compatible with mesial temporal lobe involvement. 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). Age 18-90. 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). Available for the duration of the study (6 months from screening). Exclusion Criteria: Known disorder of hemostasis. 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) Skeletal deformities or damage at the proposed implantation site to an extent that impedes correct electrode placement. Scheduled facial or cranial surgery within 6 months from enrollment. Active deep brain stimulation device. Presence of implanted ICD pacemaker, cochlear implant or other active implants. Planned transcranial magnetic stimulation (TMS) or transcranial direct current stimulation (tDCS) in the duration of the study. Presence of any implanted device at the proposed site of implantation. Known allergy towards any material that is part of the investigational device. Females of childbearing potential who are pregnant, intend to become pregnant, or are not using adequate contraceptive methods throughout the study. Performing extreme sport, including scuba diving (snorkel diving is allowed), parachute jumping or martial arts. Scheduled MRI within 5 months from enrollment. Work involving operation of MRI-scanner. Operating hand held transceivers for communication (e.g. within the police, medical, fire, air traffic control, marine or military). Working at broadcast stations for television or FM/DAB radio. Known or suspected abuse of alcohol defined as estimated consumption beyond that, which is recommended by the DHA or any other neuro-active substances. Active vagus nerve stimulator. Skin disorders near the proposed implantation site, including infection. Contraindications against the local anesthetic drug used during im- and explantation. Diabetes of any kind. Psychiatric disorders including: schizophrenia bipolar affective disorder emotionally unstable personality disorder schizoaffective disorder schizotypal disorder autism 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Troels Kjær, Professor
Organizational Affiliation
Zealand University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zealand University hospital
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31666082
Citation
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.
Results Reference
derived

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Subcutaneous EEG in Epilepsy

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