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

This study has been completed.
Sponsor:
Information provided by:
cerbomed GmbH
ClinicalTrials.gov Identifier:
NCT01178437
First received: July 29, 2010
Last updated: March 7, 2011
Last verified: March 2011
History of Changes
  Purpose

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 Intervention
Epilepsy
 Device: T-VNS® Stimulator cM02 (Transcutaneous Stimulation of the Vagus Nerve)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy Seizures
U.S. FDA Resources

Further study details as provided by cerbomed GmbH:

Primary Outcome Measures:
  • Assessment of performance [ Time Frame: 9 months ] [ Designated as safety issue: No ]

    rated by investigator

    QOLIE-89 MADRS CCTE



Secondary Outcome Measures:
  • Patient's subjective assessment of epileptic shocks [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    rated by patient. Subjective assessment of epileptic shocks and cognitive functions. Measured with "Erlanger Kognitionstest" (EKT)

  • Further assessment of performance [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    EEG long-term monitoring, MR spectroscopy

  • Assessment of Safety [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    Registration of (S)AEs and drop outs


Enrollment: 7
Study Start Date: August 2009
Study Completion Date: January 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01178437

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

No publications provided

Responsible Party: Chief Medical Officer, cerbomed GmbH
ClinicalTrials.gov Identifier: NCT01178437     History of Changes
Other Study ID Numbers: cMPsE01
Study First Received: July 29, 2010
Last Updated: March 7, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by cerbomed GmbH:
grand mal,
seizure disorder,
seizures,
convulsions,
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:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013