Subcutaneous EEG: Forecasting of Epileptic Seizures

Inclusion criteria

• Diagnosis of treatment-resistant epilepsy of any syndrome, in which seizures are detectable in scalp EEG with two electrodes
• Between the ages of 18 - 75
• Experiencing >20 seizures (with impaired awareness) per year according to seizure diary.

Exclusion criteria

• Established current diagnosis of psychogenic non-epileptic attacks (dissociative seizures)
• Frequent vigorous involuntary movements (eg. chorea, athetosis) or frequent parasomnias with major motor components (eg. sleep walking, night terrors)
• Inability to comply with the trial procedure, such as cognitive or behavioral problems
• Inability to give informed consent
• History or evidence of: Severe cardiac disease (including Pacemaker and ICD-unit), Myocardial infarction, angina pectoris or other ischaemic heart disease, Cardiac arrhythmia or Any other heart failure
• History or evidence of: Stroke, Transient ischaemic attack, Carotid or vertebral artery stenosis or dissection, Cerebral hemorrhage, Any other structural cerebral disease
• Use of following drugs: Chemotherapeutic drugs of any kind, Methotrexate, Anticoagulation treatment, Immunosuppressant treatment, Third generation antipsychotic drugs (aripiprazole, quetiapine, clozapine, ziprasidone, paliperidone, risperidone, sertindole, amisulpride, olanzapine)
• Subjects under investigation or treatment of active cancer or cancer diagnosis within the past 5 years
• Subjects known with or suspected abuse of alcohol (defined as consumption of > 250g alcohol per week or abuse of any other neuro-active substances
• Subjects involved in therapies with medical devices that deliver electrical energy into the area around the implant.
• Subjects at high risk of surgical complications, such as active systemic infection and hemorrhagic disease.
• Subjects who are allergic to the local anesthetics used during implantation.
• Subjects whose safety blood measurements (full blood count, U&E, clotting) are significantly out of range in the judgement of the CI.
• Females of childbearing potential who are pregnant or intend to become pregnant or are not using adequate contraceptive methods throughout the study (Safe anticontraceptive methods includes contraceptive pills, intrauterine device including hormone intrauterine device and sustained gestagen injection)
• Subjects who have an infection at the site of device implantation.
• Subjects who operate MRI scanners or are planned to have an MRI scan within the next year.
• Subjects with profession/hobby that includes activity imposing extreme pressure variations (e.g. diving or parachute jumping). NB: diving/snorkeling is allowed to 5 meters of depth.
• Subjects with profession/hobby that includes activity imposing an unacceptable risk for trauma against the device or the site of implantation (e.g. martial art or boxing).