Pharmacoresitant epilepsy
Conditions
Interventions
Group 1: Transcutaneous vagus nerve stimulation (t VNS) as add-on therapy to the individualized drug therapy
Group 2: Transcutaneous vagus nerve stimulation (t-VNS) sham treatment as add-on therapy to
Sponsors
Gesundheitsforen Leipzig GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Patients with pharmacoresistant epilepsy and clinically manifest seizures, such as: - Focal seizures without loss of consciousness - Focal seizures with loss of consciousness - Focal to bilateral tonic-clonic seizures - Generalized tonic-clonic seizures - Patients who have not achieved sustained seizure freedom for at least twelve months despite adequate treatment attempts with at least two tolerable, suitable, and appropriately used seizure suppressants (either as monotherapy or in combination) - An average of at least three seizures per month and no more than 21 consecutive seizure-free days in the last three months - Stable use of seizure suppressants for at least five weeks prior to study entry and throughout the entire study - Patients who are unsuitable for or refuse (further) resective epilepsy surgery
Exclusion criteria
Exclusion criteria: - Pregnant or breastfeeding women - Presence of =1 status epilepticus within the last six months prior to study enrollment - Occurrence of seizure clusters within the last six months - Unreliable or incomplete seizure documentation within the last six months - Additional existing psychogenic non-epileptic seizures - Currently implanted neurostimulation system (vagus nerve stimulation, deep brain stimulation, focal cortical stimulation) - Patients with prior t-VNS experience - Anatomical abnormalities that prevent successful insertion of the ear electrode - Substance use disorders according to DSM-5 - Serious psychiatric disorders according to DSM-5, such as severe depression or schizophrenia - Patients with active psychosis (excluding postictal psychosis), major depression, or a suicide attempt within the last year - Progressive neurological diseases, including, for example, cerebrovascular degeneration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving a reduction of at least 5 0% in mean seizure frequency at 52 ± 2 weeks compared with baseline (4-week period) between the two groups | — |
Secondary
| Measure | Time frame |
|---|---|
| - Responder rates with seizure reductions of =25% and =75% versus baseline, and seizure freedom (no seizures for =3 consecutive months) - Retention rates: Percentage of patients continuing treatment at weeks 12±2, 20±2, 36±2 and 52±2, based on predefined treatment failure events (e.g., clinically relevant worsening of seizure control, non tolerable stimulation related adverse effects, health deterioration or major ASM changes due to insufficient seizure control) - Change in seizure severity (LSSS 2.0) and health related quality of life/daily functioning (QOLIE-31) - Changes in anxiety, depression/suicidality, cognition and global mental health (GAD 7, BDI-II, MoCA, PGIC) and headache related impairment as documented in the eCRF - Incidence, type and severity of adverse events, serious and device related events, mortality and SUDEP as part of the overall safety and tolerability evaluation. | — |
Countries
Germany
Contacts
Public ContactMelanie Penke
Gesundheitsforen Leipzig GmbH
Outcome results
None listed