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

cerbomed

Status

Completed

Conditions

Epilepsy

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT01178437

cMPsE01

Details and patient eligibility

About

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.

Enrollment

7 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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