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

NCT ID: NCT01178437

Last Updated: 2011-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2011-01-31

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.

Conditions

Epilepsy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

T-VNS® Stimulator cM02

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

cerbomed GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

cerbomed GmbH

Principal Investigators

Stefan Herrmann, MD

Role: PRINCIPAL_INVESTIGATOR

University of Erlangen-Nürnberg

Locations

Epilepsiezentrum Erlangen

Erlangen, Bavaria, Germany

Countries

Germany

Other Identifiers

cMPsE01

Identifier Type: -

Identifier Source: org_study_id