G40
Conditions
Interventions
Group 1: active group: transcutaneous, non-invasive electrical stimulation of the auricular branch of the vagus nerve by using a specific ear
electrode. A cable connects this ear electrode with the st
Sponsors
cerbomed GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: To be eligible for inclusion into this study, the patient must fulfill all of the following criteria prior to enrollment: Males or females = 18 and = 65 years of age. Must be able to consent to participation by signing the informed consent form. Has any of a broad range of epilepsy syndromes (e.g. with simple or complex partial or primary or secondary generalized seizures). Has = 3 seizures per month and not more than 21 days between seizures, both prior to screening (assessed retrospectively) and during the baseline period. Is on a stable regimen of = 3 antiepileptic drugs (AEDs), has been on this regimen for at least 5 weeks prior to study enrollment, and maintains this regimen throughout the participation in the study.
Exclusion criteria
Exclusion criteria: To be eligible for inclusion into this study, the patient must not meet any of the following criteria prior to enrollment Is participating in another clinical study at the time of this study, or has participated in another study within 30 days prior to signing the informed consent form. Is pregnant or breast-feeding. Is a sexually active female of child-bearing potential unless she is using a reliable, medically-approved primary-form of birth control. At the discretion of the investigator, total abstinence from sexual intercourse is acceptable in those cases where the age, career, lifestyle or sexual orientation of the patient ensures the prevention of a pregnancy. Is an employee of the investigational site directly affiliated with this study and/or their immediate family members, an employee of the sponsor or the clinical research organization. Is unwilling or unable to adhere to all study requirements, including accurate completion of the patient diary and questionnaires at the required time points and attending all study visits. Is unable to understand the study plan, its conditions, the therapy goals and expected outcomes. Has a substance use disorder (DSM-IV). Has a major psychiatric disorder (Diagnostic and Statistics Manual of Mental Disorders), such as major depressive disorder or schizophrenia. Has a deteriorating neurological or medical condition, including for example cerebrovascular degeneration or structural damage to basal ganglia. Has any relevant cardiac disease, asthma, AIDS or HIV-infection or previous or current diagnosis of any form of cancer other than basal cell carcinoma. Is using more than 3 AEDs at the time of study enrollment or at randomization. Has a history of non-epileptic seizures. Has had more than 1 episode of status epilepticus in the 6 months prior to study enrollment. Has or has had invasive VNS or deep brain stimulation. Has undergone ablative epilepsy surgery. Has undergone cervical vagotomy. Has a skin pathology or disease such as an infection, psoriasis, or eczema in the treatment area. Has any anatomical pathology or other limitation that would prevent successful placement of the device. Has an active implantable medical device such as a cardiac pacemaker, defibrillator, neurostimulator, cochlear implant, or active drug administration device. Has any other serious medical condition that could adversely affect their participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of add-on therapy with high-level t-VNS® in comparison to add-on therapy with low-level t-VNS® at reducing seizure-frequency per 28 days in patients with drug-resistant epilepsy, as measured by the change in mean seizure-frequency per 28 days from baseline to the last 28 days of the treatment phase | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety of add-on therapy with high-level t-VNS® in comparison to add-on therapy with low-level t-VNS® in patients with drug-resistant epilepsy, the frequency, severity, nature and duration of adverse events will be assessed, and changes from baseline in physical exam results and vital signs between the two treatment groups will be compared. To evaluate the change in seizure-frequency per 28 days from baseline to the treatment period within each group. To determine the percentage of patients in each treatment group who experience a 25% reduction in seizure-frequency (change from baseline to last 28 days of treatment). To determine the percentage of patients in each treatment group who experience a 50% reduction in seizure-frequency (change from baseline to last 28 days of treatment). To evaluate changes in seizure severity in each group from baseline to the last 28 days of treatment. Via QoLiE-31P, to evaluate changes in the impact of epilepsy on the patients’ quality of life from baseline to the last 28 days of treatment. Exploratory: To gather information on the ability of treatment with high-level t-VNS® to inhibit the full development of impending seizures. To gather information on the epilepsy-related use of health-care services by patients with drug-resistant epilepsy. To gather information on school/work time missed due to epilepsy. To gather cost-effectiveness data/ data on resource utilization. | — |
Countries
Austria, Germany
Contacts
Public ContactAndreas Harlep
cerbomed
Outcome results
None listed