NCT01910129

Neurostimulation to the Vagus Nerve for the Reduction in Frequency of Seizures Associated With Epilepsy

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.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: ElectroCore INC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Seizure

Interventions

Type	Name	Description
DEVICE	gammaCore	vagal verve stimulation 3 times a day 8 hours apart

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-07-01
• Completion: 2014-10-01
• First posted: 2013-07-29
• Last updated: 2019-04-23
• Results posted: 2019-04-23

Locations

2 sites across 1 country: Australia