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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
daily, transcutaneous, electrical stimulation of the vagus nerve by the t-VNS device for a period of 9 months
Epilepsiezentrum Erlangen
Erlangen, Bavaria, Germany
Assessment of performance
rated by investigator QOLIE-89 MADRS CCTE
Time frame: 9 months
Patient's subjective assessment of epileptic shocks
rated by patient. Subjective assessment of epileptic shocks and cognitive functions. Measured with "Erlanger Kognitionstest" (EKT)
Time frame: 9 months
Further assessment of performance
EEG long-term monitoring, MR spectroscopy
Time frame: 9 months
Assessment of Safety
Registration of (S)AEs and drop outs
Time frame: 9 months
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