Status:
COMPLETED
Transcutaneous Non-invasive Stimulation of the Vagus Nerve for the Treatment of Difficult-to-treat Epilepsy
Lead Sponsor:
cerbomed GmbH
Conditions:
Epilepsy
Eligibility:
All Genders
18-75 years
Phase:
NA
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
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01178437
Start Date
August 1 2009
End Date
January 1 2011
Last Update
March 8 2011
Active Locations (1)
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1
Epilepsiezentrum Erlangen
Erlangen, Bavaria, Germany, 91054