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

cerbomed GmbH1 site in 1 country7 target enrollmentAugust 2009

ConditionsEpilepsy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Epilepsy
Sponsor: cerbomed GmbH
Enrollment: 7
Locations: 1
Primary Endpoint: Assessment of performance
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2009

End Date

January 2011

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

cerbomed GmbH

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
•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)