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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01178437
Recruitment Status : Completed
First Posted : August 10, 2010
Last Update Posted : March 8, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Epilepsy Device: T-VNS® Stimulator cM02 (Transcutaneous Stimulation of the Vagus Nerve) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Intervention Details:
  • 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
    Other Name: T-VNS® Stimulator cM02

Primary Outcome Measures :
  1. Assessment of performance [ Time Frame: 9 months ]

    rated by investigator


Secondary Outcome Measures :
  1. Patient's subjective assessment of epileptic shocks [ Time Frame: 9 months ]
    rated by patient. Subjective assessment of epileptic shocks and cognitive functions. Measured with "Erlanger Kognitionstest" (EKT)

  2. Further assessment of performance [ Time Frame: 9 months ]
    EEG long-term monitoring, MR spectroscopy

  3. Assessment of Safety [ Time Frame: 9 months ]
    Registration of (S)AEs and drop outs

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01178437

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Epilepsiezentrum Erlangen
Erlangen, Bavaria, Germany, 91054
Sponsors and Collaborators
cerbomed GmbH
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Principal Investigator: Stefan Herrmann, MD University of Erlangen-Nürnberg

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Responsible Party: Chief Medical Officer, cerbomed GmbH Identifier: NCT01178437     History of Changes
Other Study ID Numbers: cMPsE01
First Posted: August 10, 2010    Key Record Dates
Last Update Posted: March 8, 2011
Last Verified: March 2011
Keywords provided by cerbomed GmbH:
seizure disorder,
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:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases