Transcutaneous Non-invasive Stimulation of the Vagus Nerve for the Treatment of Difficult-to-treat Epilepsy

Study Overview
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Brief Summary
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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.

Official Title
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Transcutaneous Non-invasive Stimulation of the Vagus Nerve for the Treatment of Difficult-to-treat Epilepsy - a Prospective Pilot Study Regarding Safety, Effectiveness and Clinical Performance

Conditions
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Epilepsy

Intervention / Treatment
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* Device: T-VNS® Stimulator cM02 (Transcutaneous Stimulation of the Vagus Nerve)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: T-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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of performance | rated by investigator QOLIE-89 MADRS CCTE | 9 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | EEG long-term monitoring, MR spectroscopy | 9 months | 
| Assessment of Safety | Registration of (S)AEs and drop outs | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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