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

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

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 Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Device: T-VNS® Stimulator cM02 (Transcutaneous Stimulation of the Vagus Nerve)

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Epilepsiezentrum Erlangen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: cerbomed GmbH
• Investigators: Principal Investigator: Stefan Herrmann, MD, University of Erlangen-Nürnberg

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: July 29, 2010
• First Submitted That Met QC Criteria: August 9, 2010
• First Posted (Estimate): August 10, 2010

Study Record Updates

• Last Update Posted (Estimate): March 8, 2011
• Last Update Submitted That Met QC Criteria: March 7, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• 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
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: cMPsE01