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
|Condition or disease||Intervention/treatment||Phase|
|Temporal Lobe Epilepsy||Device: Hypo-safe implantable EEG electrode and data storage device||Not Applicable|
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)|
|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|
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.
- 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.
- 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.
- 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.
- 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
- 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:
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- Correlation between cognitive test scores number and IEDs and/or seizures within 24 hours [ Time Frame: 30 months ]
The following correlations will be investigated:
- Strength and significance of the correlation between the cognitive test score and the time from last seizure and time to next seizure.
- 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.
- Strength and significance of the correlation between the cognitive test score and the number of IEDs on the previous night.
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
|Contact: Troels Kjær, Professorfirstname.lastname@example.org|
|Contact: Sigge Weisdorf, MDemail@example.com|
|Zealand University hospital||Recruiting|
|Roskilde, Denmark, 4000|
|Contact: Troels Wesenberg, Professor firstname.lastname@example.org|
|Contact: Sigge Weisdorf, MD 004547322784 email@example.com|
|Principal Investigator:||Troels Kjær, Professor||Zealand University Hospital|