Epilepsy
Conditions
Keywords
seizure disorder,, seizures,, convulsions,, grand mal,, petit mal,, absence seizures,, repeated seizures,, children's seizures,, secondary epilepsy,, symptomatic epilepsy,, generalized seizures,, partial seizure,, focal seizure,, partial complex seizure,, anticonvulsant medication
Brief summary
The aim of the study is to prove the feasibility and safety of transcutaneous, electrical stimulation of the vagus nerve in patients with difficult-to-treat forms of epilepsy.
Interventions
DEVICET-VNS® Stimulator cM02 (Transcutaneous Stimulation of the Vagus Nerve)
daily, transcutaneous, electrical stimulation of the vagus nerve by the t-VNS device for a period of 9 months
Sponsors
cerbomed GmbH
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Written Informed Consent * Patients of both gender, aged from 18-75 years * Diagnosis of epilepsy according to the diagnosis criteria of the DSM IV/ ICD 10 (especially G 40.1 /G 40.2/ G 40.3) * Insufficient response to at least one attempt of treatment in medical history with anticonvulsive medication, dosed sufficiently long and high * Antiepileptic Drugs (AED) therapy must be stable at a level that promises long-term continuity for at least 10 before study start and has to be continued for at least 3 months during treatment phase
Exclusion criteria
* Absence of Informed Consent * Pregnancy * Psychiatric diseases, especially post-traumatic stress disorder, obsessive-compulsive disorders, schizophrenia, Borderline personality disorders (BPD), character disorders as well as major depressive disorders, anxiety disorders and eating disorders as comorbidity. * Abuse of drugs and alcohol until 12 weeks before study start * Cerebrovascular diseases * Dementia * Severe traumatic brain injury in medical history including invasive and non-invasive methods of therapy (tumor surgery, Gamma Knife Surgery) * Indications of structural impairment of the basal ganglia or the brain stem * active implants (e.g. cochlea implants, VNS, pacemaker) * Severe neurological diseases (e.g. Morbus Parkinson, systemic neurologic diseases * severe internistic diseases (e.g. arterial hypertension, respiratory failure) * Bronchial asthma * malignant diseases of any kind, within five years before study start * Severe active infectious diseases (e.g. HIV, hepatitis) * Bone diseases (e.g. Morbus Paget, recent fractures) * Diseases of the ENT body system: Hearing loss of the left ear which is treated with a hearing instrument, all dermatologic and infectious diseases which affect the area around the pinna and the ear canal, severe malformation of the pinna * Vagotomy * Concurrent participation in other studies * Other circumstances that in the opinion of the investigator might be an obstacle for enrolling the subject
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of performance | 9 months | rated by investigator QOLIE-89 MADRS CCTE |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient's subjective assessment of epileptic shocks | 9 months | rated by patient. Subjective assessment of epileptic shocks and cognitive functions. Measured with Erlanger Kognitionstest (EKT) |
| Further assessment of performance | 9 months | EEG long-term monitoring, MR spectroscopy |
| Assessment of Safety | 9 months | Registration of (S)AEs and drop outs |
Countries
Germany
Outcome results
None listed