NCT02089243

Controlled Randomized Vagus Nerve Stimulation (VNS) Therapy Versus Resection (CoRaVNStiR)

Prospective Randomized Controlled Study of Vagus Nerve Stimulation Therapy in the Patients With Medically Refractory Medial Temporal Lobe Epilepsy; Controlled Randomized Vagus Nerve Stimulation Versus Resection (CoRaVNStiR)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 12 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Background: There are a variety of treatment options for medically refractory medial temporal lobe epilepsy. Evidence from randomized trials indicates vagus nerve stimulation therapy can be used as a proven therapy for medically refractory medial temporal lobe epilepsy. Resective surgery is one of the most commonly used methods to treat medically refractory medial temporal lobe epilepsy. The aim of this study is to compare the effects of vagus nerve stimulation therapy and resective surgery in the treatment of the medically refractory medial temporal lobe epilepsy. Methods/Design: In this article, we report the design and protocol of a randomized controlled trial to treat medically refractory medial temporal lobe epilepsy with vagus nerve stimulation therapy or resective surgery. In total, 40 patients aged 12 to 60 years with medically refractory medial temporal lobe epilepsy will be assessed. There are two treatment groups. These patients are randomly assigned to be in one of the following two treatment groups, i.e. 1) undergo temporal lobe resection group, 2) receive vagus nerve stimulation therapy group. The primary outcome is to assess whether vagus nerve stimulation produces a reduction in mean monthly seizure frequency that is comparable to resection at 3 months, 6 months, 9 months and 12 months of follow-up. The secondary outcomes include the neuropsychological, seizure severity, seizure type, quality of life, mood assessment, operative and postoperative complications and long-term side effects, compared to resection. Discussion: The result of this trial will assess the efficacy of using vagus nerve stimulation therapy or resective surgery to treat medically refractory medial temporal lobe epilepsy, and to determine a better therapy for treating medically refractory medial temporal lobe epilepsy.

Detailed description

Published data suggest that patients with temporal lobe epilepsy who continue to experience seizures after trials of two or three antiepileptic drugs are unlikely to become seizure-free with further attempts at resection. Such patients may experience poor quality of life and functional outcomes from continuing seizures and the adverse effects associated with further attempts at resection. Vagus nerve stimulation is a minimally invasive treatment for epilepsy with well-established effectiveness as an adjunctive treatment for partial seizures refractory to resection, but there are no vagus nerve stimulation is a minimally invasive treatment for epilepsy with well-established effectiveness as an adjunctive treatment for partial seizures refractory to resection, but there are no controlled randomized clinical trials comparing the effectiveness of Vagus Nerve Stimulation therapy with resection in such patients.

Conditions

• Epilepsy

Interventions

Type	Name	Description
PROCEDURE	Vagus nerve stimulation therapy	The adjustments in device parameters were performed, individually, and solely at the discretion of the primary epileptologist with a formal protocol guiding changes.
PROCEDURE	Resective surgery	The experienced neurosurgery are responsible for the selection of surgical techniques employed for medically refractory medial temporal lobe epilepsy that provide an effective treatment with significant preservation of neurological function and acceptable surgical risks.

Timeline

• Start date: 2014-06-01
• Primary completion: 2016-07-01
• Completion: 2017-07-01
• First posted: 2014-03-17
• Last updated: 2014-03-17

Locations

1 site across 1 country: China