Controlled Randomized Vagus Nerve Stimulation (VNS) Therapy Versus Resection (CoRaVNStiR) (CoRaVNStiR)
|ClinicalTrials.gov Identifier: NCT02089243|
Recruitment Status : Unknown
Verified March 2014 by Xijing Hospital.
Recruitment status was: Not yet recruiting
First Posted : March 17, 2014
Last Update Posted : March 17, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Procedure: Vagus nerve stimulation therapy Procedure: Resective surgery||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||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)|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||July 2017|
Experimental: Vagus nerve stimulation therapy
Surgical follow-up typically occurred 2 weeks postoperatively and, subsequently, on a variable schedule as indicated. The adjustments in device parameters were performed, individually, and solely at the discretion of the primary epileptologist with a formal protocol guiding changes. Retrospective chart review was performed to collect follow-up and outcome data. At the time of last available clinical follow-up, the following data were collected: mean weekly seizure frequency (from seizure logs kept by caretakers or patient or caretaker report averaged of the last 3 months prior to ﬁnal follow-up), complications of VNS therapy, duration of VNS therapy, timing and all subsequent surgical procedures.
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.
Experimental: Resective surgery
The type of surgery performed consisted of standard anterior temporal lobectomy, electrocorticography tailored temporal lobectomy, anteromedial temporal lobectomy, transcortical or transsylvian or subtemporal selective amygdalohippocampectomy, temporal lobe disconnection and hippocampal transection.
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.
- seizure frequency [ Time Frame: 3 months ]
- neuropsychological examination [ Time Frame: 12 months ]
- responder rates [ Time Frame: during 3 month intervals ]
- mean seizure free interval [ Time Frame: during 3 month intervals ]
- seizure severity [ Time Frame: during 3-month intervals ]
- quality of life [ Time Frame: 3 months, 6 months, 9 months and 12 months ]
- complications [ Time Frame: during twelve months after inclusion. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02089243
|Contact: Yanchun YC Deng, MD. PhD.||+86 29 firstname.lastname@example.org|
|the Department of Neurology, Xijing Hospital|
|Xi'an, Shaanxi, China, 710032|
|Contact: Yanchun YC Deng, MD, PhD +86 29 84773994 email@example.com|
|Study Director:||Yanchun YC Deng, MD, PhD||the Department of Neurology, Xijing Hospital|