EpilepsyNCT04526418
Evaluation of the 24/7 EEG SubQ System for Ultra Long-Term Recording of Patients With Epilepsy Involving the Temporal Lobe Region.
A study testing 24/7 EEG™ SubQ system in people with Epilepsy, run by UNEEG Medical A/S at 12 sites in 3 countries.
Trial summary
The 24/7 EEG™ SubQ system will be compared to simultaneously recorded video-EEG in the Epilepsy Monitoring Unit (gold standard) and to self-reported seizure log books throughout 12 weeks of outpatient EEG recording. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- 24/7 EEG™ SubQ system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 21 Apr 2021to 29 Aug 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is 18-75 years old.
- Semiology of seizures compatible with temporal lobe involvement.
- Paraclinical findings supporting temporal seizure involvement. Such proof may consist of: - previous EEG recording interpreted as compatible with temporal involvement OR - radiological findings demonstrating pathology in the temporal area (CT, MRI, FDG-PET or SPECT).
- Uncontrolled epileptic seizures.
- Subject has planned clinical EMU admission with an admission goal including capturing epileptic seizures, within 12 weeks after the date of UNEEG™ SubQ implant.
- Subject is willing and able to provide written informed consent.
- Subject is able to complete all study-required procedures, assessments and follow-up.
Who cannot join
- Subject has a condition that places him/her at a high at high risk of surgical complications, such as an active systemic infection or a hemorrhagic disease.
- Subject receives frequent (more than 2 days per week) treatment with drugs of the following types:
- antiplatelets
- anticoagulants
- chemotherapeutics
- non-steroid anti-inflammatory drugs (NSAID)
Show all 21Show fewer
- Subject has skeletal deformities or damage at the proposed implantation site to an extent that impedes correct electrode placement.
- Subject is involved in therapies with other active implantable devices that deliver electrical energy above the clavicular area, such as implantable brain stimulation, external/transcranial brain stimulation, vagus nerve stimulator (VNS) and cochlear implant(s).
- Subject is pregnant
- Subject has contraindicated profession or hobby
- Subject is scheduled to undergo contraindicated treatments/investigations
- Infection at the implant site
- Subject has contraindication to the use of anesthetic used for in/ex plantation.
- Subject is unable to use/operate the device system
- Subject has abnormal Laboratory findings as follows:
- Serum creatinine ≥ 3 times upper reference value
- Alanine aminotransferase (ALT), alkaline phosphatase or bilirubin ≥ 3 times upper reference value
- Activated Partial Thromboplastin Time (APTT) \> 50 seconds
- thrombocyte count \< 50 or \>1000 x 109/L
- International Normalised Ratio (INR) ≥ 1.6
- Any other clinical or paraclinical finding that in the opinion of the Investigator would interfere with participation in the study or would confound interpretation of the study results.
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
United States9 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Cleveland Clinic, Neurological Institute
Cleveland, Ohio, 44195
Northwell Health Department of Neurosurgery
Great Neck, New York, 11021
UT Health Houston
Houston, Texas, 77030
University of California
Los Angeles, California, 90095
Hackensack Meridian Health
Neptune City, New Jersey, 07753
University of Pennsylvenia
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Rochester, Minnesota, 55905
University of South Florida (USF) Neurology Department
Tampa, Florida, 33606
Germany2 sites
Krankenhaus Mara, Gesellschaft für Epilepsieforschung e.V.
Bielefeld, 33617
Universität Klinikum Freibrug
Freiburg im Breisgau, 79106
About this study
Official title: Evaluation of the 24/7 EEG SubQ System for Ultra Long-Term Recording of Patients With Epilepsy Involving the Temporal Lobe Region. An Open-label, Prospective, Paired, Comparative Study.
The 24/7 EEG™ SubQ system will be compared to simultaneously recorded video-EEG in the Epilepsy Monitoring Unit (gold standard) and to self-reported seizure log books throughout 12 weeks of outpatient EEG recording.
The present study is a 12-week open-label, prospective study with a paired, comparative design for pivotal evaluation of the safety and effectiveness of the 24/7 EEGTM SubQ system in subjects with epilepsy involving the temporal lobe region .
2-5 sites in Europe Up to 10 sites in US
- Conditions
- Epilepsy
- Being tested
- 24/7 EEG™ SubQ system
- Keywords
- Ultra Long-Term Recording of Patients with Epilepsy
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24/7 EEG™ SubQ systemDevice
Electrographic seizure recording sensitivity of an ipsilaterally implanted 24/7 EEG™ SubQ system: proportion of identified ipsilateral seizures as compared to ipsilateral video-EEG during admission to the Epilepsy Monitoring Unit
| Study group | Role | What they receive |
|---|---|---|
| 24/7 EEG™ SubQ System | Experimental | To demonstrate the electrographic seizure recording effectiveness of the 24/7 EEG™ SubQ system by comparison to simultaneous inpatient video-EEG data. Receives: Device: 24/7 EEG™ SubQ system |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of seizures
numbers of seizures as detected in EEG data from SubQ to be compared with number of seizures detected in golden standard (video EEG).
Measured: comparasion in EMU for 3-14 days period, where patients are hospitalized.
Secondary outcomes (1)
adverse event
safety reporting
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start21 Apr 2021
- Primary completion22 Jul 2025
- Study completion29 Aug 2025
Why it stopped: Futility analysis reached
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- open-label, prospective study with a paired comparative design for pivotal evaluation of the safety and effectiveness of the 24/7 EEC SubQ system in subjects with epilepsy involving the temporal lobe region.
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNEEG Medical A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Gelfand, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04526418
- Sponsor's protocol ID
- U002
- Status last verified
- Aug 2025
- First submitted
- 10 Aug 2020
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the 24/7 EEG SubQ System for Ultra Long-Term Recording of Patients With Epilepsy Involving the Temporal Lobe Region. An Open-label, Prospective, Paired, Comparative Study.
- ClinicalTrials.gov ID
- NCT04526418
- Acronym / sponsor ID
- U002
- Conditions
- Epilepsy
- Keywords
- Ultra Long-Term Recording of Patients with Epilepsy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility analysis reached
- Enrolment
- 64 participants (actual)
- Lead sponsor
- UNEEG Medical A/SIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 22 Jul 2025 (actual)
- Study completion
- 29 Aug 2025 (actual)
- First posted
- 25 Aug 2020 (actual)
- 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 24/7 EEG™ SubQ system will be compared to simultaneously recorded video-EEG in the Epilepsy Monitoring Unit (gold standard) and to self-reported seizure log books throughout 12 weeks of outpatient EEG recording.
The present study is a 12-week open-label, prospective study with a paired, comparative design for pivotal evaluation of the safety and effectiveness of the 24/7 EEGTM SubQ system in subjects with epilepsy involving the temporal lobe region .
2-5 sites in Europe Up to 10 sites in US
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open-label, prospective study with a paired comparative design for pivotal evaluation of the safety and effectiveness of the 24/7 EEC SubQ system in subjects with epilepsy involving the temporal lobe region.
| Arm | Type | Receives |
|---|---|---|
| 24/7 EEG™ SubQ System | Experimental | Device: 24/7 EEG™ SubQ systemTo demonstrate the electrographic seizure recording effectiveness of the 24/7 EEG™ SubQ system by comparison to simultaneous inpatient video-EEG data. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject is 18-75 years old.
- Semiology of seizures compatible with temporal lobe involvement.
- Paraclinical findings supporting temporal seizure involvement. Such proof may consist of: - previous EEG recording interpreted as compatible with temporal involvement OR - radiological findings demonstrating pathology in the temporal area (CT, MRI, FDG-PET or SPECT).
- Uncontrolled epileptic seizures.
- Subject has planned clinical EMU admission with an admission goal including capturing epileptic seizures, within 12 weeks after the date of UNEEG™ SubQ implant.
Key exclusion criteria (21 listed)
- Subject has a condition that places him/her at a high at high risk of surgical complications, such as an active systemic infection or a hemorrhagic disease.
- Subject receives frequent (more than 2 days per week) treatment with drugs of the following types:
- Subject has skeletal deformities or damage at the proposed implantation site to an extent that impedes correct electrode placement.
- Subject is involved in therapies with other active implantable devices that deliver electrical energy above the clavicular area, such as implantable brain stimulation, external/transcranial brain stimulation, vagus nerve stimulator (VNS) and cochlear implant(s).
- Subject is pregnant
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 |
|---|---|---|
| 24/7 EEG™ SubQ systemElectrographic seizure recording sensitivity of an ipsilaterally implanted 24/7 EEG™ SubQ system: proportion of identified ipsilateral seizures as compared to ipsilateral video-EEG during admission to the Epilepsy Monitoring Unit | Device | 24/7 EEG™ SubQ System |
Primary outcome
number of seizures
Time frame: comparasion in EMU for 3-14 days period, where patients are hospitalized.
numbers of seizures as detected in EEG data from SubQ to be compared with number of seizures detected in golden standard (video EEG).
1 secondary outcome
adverse event
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Futility analysis reached). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Epilepsy
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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.
Michael Gelfand principal investigator
University of Pennsylvania
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 24/7 EEG™ SubQ system in people with Epilepsy, run by UNEEG Medical A/S at 12 sites in 3 countries.
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 21 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: stopped early, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Germany, Belgium. 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 was stopped early (reason given: Futility analysis reached). Results are not available in the source record.
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?
number of seizures (time frame: comparasion in EMU for 3-14 days period, where patients are hospitalized.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2025.