Temporal Lobe EpilepsyNCT02946151
Subcutaneous EEG in Epilepsy
A study testing UNEEG implantable EEG electrode and data storage device in people with Temporal Lobe Epilepsy, run by Zealand University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Temporal Lobe Epilepsy
- What is being tested?
- UNEEG implantable EEG electrode and data storage device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2016to 11 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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)
Show all 45Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Temporal Lobe Epilepsy
- Being tested
- UNEEG implantable EEG electrode and data storage device
- Keywords
- Epilepsy, Seizure monitoring, Electroencephalography
- Medical subject headings
- Epilepsy, Temporal Lobe, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UNEEG implantable EEG electrode and data storage deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Implantation | Experimental | Implantation of a subcutaneous electrode and connection to the external logging device Receives: Device: UNEEG implantable EEG electrode and data storage device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure comparison
Qualitative comparison of patient-recorded seizures and EEGgraphical seizures
Measured: 24 months
Adverse events
Descriptive account of device related adverse events
Measured: 24 months
Compliance
Descriptive account of compliance in use of the investigational device
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study startNov 2016
- Primary completion23 Jan 2019
- Study completion11 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Temporal Lobe EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- UNEEG Medical A/S, Technical University of Denmark
- Responsible party
- Sponsor
- Investigators
- Troels Kjær, Professor, Principal investigator, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946151
- Sponsor's protocol ID
- 2016IL01
- Other IDs
- CIV-16-05-015704
- Status last verified
- May 2019
- First submitted
- 19 Oct 2016
- Last updated
- 8 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31666082
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcutaneous EEG in Epilepsy - Proof of Concept and Clinical Applications
- ClinicalTrials.gov ID
- NCT02946151
- Acronym / sponsor ID
- 2016IL01
- Conditions
- Temporal Lobe Epilepsy
- Keywords
- Epilepsy, Seizure monitoring, Electroencephalography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- UNEEG Medical A/S, Technical University of Denmark
- Study start
- Nov 2016
- Primary completion
- 23 Jan 2019 (actual)
- Study completion
- 11 Feb 2019 (actual)
- First posted
- 27 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implantation | Experimental | Device: UNEEG implantable EEG electrode and data storage deviceImplantation of a subcutaneous electrode and connection to the external logging device |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Semiology of some seizures compatible with mesial temporal lobe involvement.
- Paraclinical findings supporting mesial temporal seizure focus. Such proof may consist of:
- 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).
Key exclusion criteria (45 listed)
- Known disorder of hemostasis.
- Daily or frequent (more than 2 days per week) treatment with any drugs of the following types:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UNEEG implantable EEG electrode and data storage deviceThe 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. | Device | Implantation |
Primary outcome
Seizure comparison
Time frame: 24 months
Qualitative comparison of patient-recorded seizures and EEGgraphical seizures
Adverse events
Time frame: 24 months
Descriptive account of device related adverse events
Compliance
Time frame: 24 months
Descriptive account of compliance in use of the investigational device
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2019.
- Derived from this study: PubMed 31666082Gangstad 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Troels Kjær, Professor principal investigator
Zealand University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UNEEG implantable EEG electrode and data storage device in people with Temporal Lobe Epilepsy, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizure comparison (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02946151, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2019.