Clinical trial NCT01178437: Transcutaneous Non-invasive Stimulation of the Vagus Nerve for the Treatment of Difficult-to-treat Epilepsy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Keywords: 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
Lead sponsor: cerbomed GmbH
Sponsor class: INDUSTRY
First posted: 2010-08-10
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Assessment of performance
timeFrame: 9 months
Secondary outcomes:
measure: Patient's subjective assessment of epileptic shocks
timeFrame: 9 months
measure: Further assessment of performance
timeFrame: 9 months
measure: Assessment of Safety
timeFrame: 9 months
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Epilepsiezentrum Erlangen
state: Bavaria
Study officials:
affiliation: University of Erlangen-Nürnberg
name: Stefan Herrmann, MD
role: PRINCIPAL_INVESTIGATOR
References: