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

Not Applicable

Completed

• Conditions: Epilepsy

• Registration Number: NCT01178437
• Lead Sponsor: cerbomed GmbH

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2010-07-29
• Study First Submitted QC: 2010-08-09
• Study First Posted: 2010-08-10
• Primary Completion: 2010-09
• Study Completion: 2011-01
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-07
• Last Update Posted: 2011-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Assessment of performance	9 months	rated by investigator; QOLIE-89 MADRS CCTE

Secondary Outcome Measures

Name	Time	Method
Patient's subjective assessment of epileptic shocks	9 months	rated by patient. Subjective assessment of epileptic shocks and cognitive functions. Measured with "Erlanger Kognitionstest" (EKT)
Further assessment of performance	9 months	EEG long-term monitoring, MR spectroscopy
Assessment of Safety	9 months	Registration of (S)AEs and drop outs

Trial Locations

Locations (1)

Epilepsiezentrum Erlangen; 🇩🇪 Erlangen, Bavaria, Germany