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Trial record 6 of 1473 for:    "Epilepsy" OR "pyridoxal 5'-phosphate-dependent epilepsy"

Subcutaneous EEG in Epilepsy

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ClinicalTrials.gov Identifier: NCT02946151
Recruitment Status : Recruiting
First Posted : October 27, 2016
Last Update Posted : July 6, 2017
Sponsor:
Collaborators:
UNEEG Medical A/S
Technical University of Denmark
Information provided by (Responsible Party):
Zealand University Hospital

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

Condition or disease Intervention/treatment Phase
Temporal Lobe Epilepsy Device: Hypo-safe implantable EEG electrode and data storage device Not Applicable

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 observation 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.

Because of the huge amounts of EEGraphical data generated from the very long-term monitoring, an automated seizure detection algorithm will be developed specifically for this device. The algorithm will be trained on known data and adjusted along the way if deemed necessary. All findings from the automated algorithm will be double-checked by a neurophysiologist/neurologist.

Data regarding sleep quality will be collected in part by actigraphy and in part by daily questionnaires delivered by smartphone. Cognitive performance testing, seizure log/description and medication log will also be handled via a specially designed smartphone app.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Subcutaneous EEG in Epilepsy - Proof of Concept and Clinical Applications
Study Start Date : November 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Arm Intervention/treatment
Experimental: Implantation
Intervention: Implantation of the subcutaneous electrode and connection to the external logging device
Device: Hypo-safe 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.




Primary Outcome Measures :
  1. Sensitivity for detection of temporal lobe seizures [ Time Frame: 18 months ]
    The proportion of EEGraphical temporal lobe seizures detected by the IL01 compared to the number of EEGraphical temporal lobe seizures detected by standard scalp EEG during admission.

  2. Sensitivity for reporting of temporal lobe seizures [ Time Frame: 24 months ]
    The proportion of reported temporal lobe seizures compared to the number of temporal lobe seizures detected by the IL01 during home monitoring.


Secondary Outcome Measures :
  1. Waveform similarity [ Time Frame: 18 months ]
    The correlation coefficient and the mean absolute deviation between averaged ictal and interictal spikes and sharp-waves obtained from the IL01 and scalp EEG, respectively.

  2. Sleep stage scoring [ Time Frame: 18 months ]
    To compare sleep stage scoring based on EEGraphical data obtained from the IL01 to that based on EEGraphical data from ordinary scalp EEG

  3. Sleep quality measured by number of awakenings by actigraphy and subjective sleep quality scoring and relationship to interictal epileptiform discharges (IEDs) and epileptic seizures [ Time Frame: 30 months ]

    The following correlations will be investigated:

    1. Strength and significance of the correlation between the sleep quality score of a given night and the number of temporal lobe seizures for that night and the following night.
    2. Strength and significance of the correlation between the number of temporal lobe seizures on a given day and the number of awakenings on the previous or the following night.
    3. Strength and significance of the correlation between the number of IEDs on a given night and sleep quality score for the number of awakenings on that same night.
    4. Strength and significance of the correlation between the number of IEDs on a given day and sleep quality score for the previous or the following night.
    5. Strength and significance of the correlation between the number of IEDs on a given day and the number of awakenings on the previous or the following night.

  4. IEDs and the nightly EEG [ Time Frame: 30 months ]
    To determine whether a correlation exists between any specific EEGraphical features (from nightly recordings) and number of IEDs the following day

  5. Correlation between cognitive test scores number and IEDs and/or seizures within 24 hours [ Time Frame: 30 months ]

    The following correlations will be investigated:

    1. Strength and significance of the correlation between the cognitive test score and the time from last seizure and time to next seizure.
    2. Strength and significance of the correlation between the cognitive test score and the number of IEDs in the last 1, 3 and 6 hours preceding the test and the 1, 3 and 6 hours after the test.
    3. Strength and significance of the correlation between the cognitive test score and the number of IEDs on the previous night.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02946151


Contacts
Contact: Troels Kjær, Professor twk@regionsjaelland.dk
Contact: Sigge Weisdorf, MD swf@regionsjaelland.dk

Locations
Denmark
Zealand University hospital Recruiting
Roskilde, Denmark, 4000
Contact: Troels Wesenberg, Professor       twk@regionsjaelland.dk   
Contact: Sigge Weisdorf, MD    004547322784    swf@regionsjaelland.dk   
Sponsors and Collaborators
Zealand University Hospital
UNEEG Medical A/S
Technical University of Denmark
Investigators
Principal Investigator: Troels Kjær, Professor Zealand University Hospital

Responsible Party: Zealand University Hospital
ClinicalTrials.gov Identifier: NCT02946151     History of Changes
Other Study ID Numbers: 2016IL01
CIV-16-05-015704 ( Other Identifier: EUDAMED )
First Posted: October 27, 2016    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Zealand University Hospital:
Epilepsy
Seizure monitoring
Electroencephalography

Additional relevant MeSH terms:
Epilepsy
Epilepsy, Temporal Lobe
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epilepsies, Partial