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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T-VNS® Stimulator cM02 (Transcutaneous Stimulation of the Vagus Nerve) | Device | daily, transcutaneous, electrical stimulation of the vagus nerve by the t-VNS device for a period of 9 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of performance | rated by investigator QOLIE-89 MADRS CCTE | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's subjective assessment of epileptic shocks | rated by patient. Subjective assessment of epileptic shocks and cognitive functions. Measured with "Erlanger Kognitionstest" (EKT) | 9 months |
| Further assessment of performance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Herrmann, MD | University of Erlangen-Nürnberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Epilepsiezentrum Erlangen | Erlangen | Bavaria | 91054 | Germany |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| D004830 | Epilepsy, Tonic-Clonic |
| D004832 | Epilepsy, Absence |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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EEG long-term monitoring, MR spectroscopy
| 9 months |
| Assessment of Safety | Registration of (S)AEs and drop outs | 9 months |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004829 | Epilepsy, Generalized |
| D000073376 | Epileptic Syndromes |