Evaluation of the 24/7 EEG SubQ System for Ultra Long-Term Recording of Patients With Epilepsy Involving the Temporal Lobe Region.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-21

Study Completion Date

2025-08-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Home Ultra-long Term EEG Monitoring for Rare Epilepsies and Developmental and Epileptic Encephalopathies

NCT06855901

Epilepsies Epilepsies, Focal Epileptic Encephalopathy

RECRUITING NA

Optimizing Therapy in Epilepsy Using Seizure Forecasts Via EEG and Wearables

NCT07012148

Focal Epilepsy Generalized Seizure Drug Refractory Epilepsy

RECRUITING NA

Subcutaneous EEG in Epilepsy

NCT02946151

Temporal Lobe Epilepsy

COMPLETED NA

Clinical Validation of zEEG, a Wireless EEG Recording System for Pediatric and Adult Patients With Epilepsy

NCT05123469

Epilepsy EEG With Periodic Abnormalities EEG With Abnormally Slow Frequencies +2 more

UNKNOWN

Real World Testing and Cost-effectiveness Analysis of Subcutaneous EEG

NCT06144047

Epilepsy

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Epilepsy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

24/7 EEG™ SubQ System

To demonstrate the electrographic seizure recording effectiveness of the 24/7 EEG™ SubQ system by comparison to simultaneous inpatient video-EEG data.

Group Type EXPERIMENTAL

24/7 EEG™ SubQ system

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

24/7 EEG™ SubQ system

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Subject is 18-75 years old.
2. Semiology of seizures compatible with temporal lobe involvement.
3. 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).
4. Uncontrolled epileptic seizures.
5. Subject has planned clinical EMU admission with an admission goal including capturing epileptic seizures, within 12 weeks after the date of UNEEG™ SubQ implant.
6. Subject is willing and able to provide written informed consent.
7. Subject is able to complete all study-required procedures, assessments and follow-up.

Exclusion Criteria

1. 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.
2. Subject receives frequent (more than 2 days per week) treatment with drugs of the following types:

1. antiplatelets
2. anticoagulants
3. chemotherapeutics
4. non-steroid anti-inflammatory drugs (NSAID)
3. Subject has skeletal deformities or damage at the proposed implantation site to an extent that impedes correct electrode placement.
4. 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).
5. Subject is pregnant
6. Subject has contraindicated profession or hobby
7. Subject is scheduled to undergo contraindicated treatments/investigations
8. Infection at the implant site
9. Subject has contraindication to the use of anesthetic used for in/ex plantation.
10. Subject is unable to use/operate the device system
11. 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) \&gt; 50 seconds
* thrombocyte count \&lt; 50 or \&gt;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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No