A Randomized, Multi-center, Double-blind, Parallel, Crossover Study of a Non-invasive Neurostimulation to the Vagus Nerve With the gammaCore Device for the Reduction in Frequency of Seizures Associated With Epilepsy.

ElectroCore INC2 sites in 1 country13 target enrollmentJuly 2013

ConditionsSeizure

Overview

Phase: N/A
Intervention: Not specified
Conditions: Seizure
Sponsor: ElectroCore INC
Enrollment: 13
Locations: 2
Primary Endpoint: Frequency of Seizures
Status: Terminated
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to see the effects of non-invasive vagal nerve stimulation for the reduction in frequency of seizure associated with epilepsy in subjects 18 or older.

Detailed Description

The purpose of the study is to determine the effects of non-invasive vagus nerve stimulation for the reduction in frequency of seizure associated with epilepsy in subjects 18 or older. Subjects will record 4 weeks of baseline seizure activity before being randomized for a period of 8 weeks to receive and active treatment to an active-sham treatment. All subjects will then receive another 8 weeks of active treatment.

Registry

clinicaltrials.gov

Start Date

July 2013

End Date

October 2014

Last Updated

7 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

ElectroCore INC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The patient is diagnosed with epilepsy with; primary generalized tonic-clonic or partial complex or simple complex or focal onset seizures, with or without secondary generalization.
•The patient's present antiepileptic drug (AED) therapy is ineffective or intolerable
•The patient is receiving a stable dose of up to 2 oral AED medication(s) and is not expected to have any change in his/her baseline AED treatment during the treatment period.
•The patient is having more than 2 recordable seizures a month.

Exclusion Criteria

•The patient has had status epilepticus within the last six months.
•The patient has had epilepsy surgery or a VNS implant.
•The patient has had a history or presence of seizures occurring only in clusters (too frequently or indistinctly separated to be reliably counted).
•The patient has had 4 weeks continuous seizure freedom last 2 months.
•The patient has psychogenic non-epileptic seizures (PNES) seizures.
•The patient has a concomitant progressive CNS disease including progressive myoclonus epilepsy.
•The patient has a significant history of cardiac, renal, neurologic (other than epilepsy), psychiatric, oncologic, endocrinologic, metabolic, or hepatic disease, which would adversely affect their participation in this study.
•The patient has had an episode of status epilepticus within 4 weeks of Screening.
•Has a lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal anatomy at the GammaCore treatment site.
•Has known or suspected severe atherosclerotic cardiovascular disease, severe carotid artery disease (e.g. bruits or history of TIA or CVA), congestive heart failure (CHF), known severe coronary artery disease or recent myocardial infarction.