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

NCT02089243 | Unknown DMC

• 1 other identifier: xijing-009
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Epilepsy

Keywords

Epilepsy,Temporal Lobe; Brain Diseases

Outcome Measures

Primary Outcomes (1)

• seizure frequency

  3 months

Secondary Outcomes (6)

• neuropsychological examination

  12 months

• responder rates

  during 3 month intervals

• mean seizure free interval

  during 3 month intervals

• seizure severity

  during 3-month intervals

• quality of life

  3 months, 6 months, 9 months and 12 months

Study Arms (2)

Vagus nerve stimulation therapy

EXPERIMENTAL

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

Resective surgery

EXPERIMENTAL

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

Interventions

Vagus nerve stimulation therapy PROCEDURE

The adjustments in device parameters were performed, individually, and solely at the discretion of the primary epileptologist with a formal protocol guiding changes.

Vagus nerve stimulation therapy

Resective surgery PROCEDURE

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.

Resective surgery

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Presurgical candidates with pharmacoresistant partial seizures despite optimal medical treatment and history of medically refractory medial temporal lobe epilepsy
• Age above 12 years, below 60 years
• Average of 2 partial seizures per month during a baseline of 2 months
• Recording of seizures must have been done in a prospective manner using standard seizure diaries
• Video-EEG characteristics showing temporal lobe seizure onset (left-sided or right-sided seizure onset) in at least one recorded habitual seizure
• Presence of a structural abnormality in the medial temporal lobe, suggestive of hippocampal sclerosis as evidenced by optimum MRI
• Women of child-bearing age will be required to use a reliable method of contraception during the study duration,
• Patient must be able to provide reliable seizure counts using seizure diaries and to complete the evaluations specified in the study procedures flow chart
• Patient must provide written informed consent, or legal guardian must give written permission and the minor provide written assent.

You may not qualify if:

• Extratemporal epilepsy; multifocal epilepsy; evidence of bilateral medial medically refractory medial temporal lobe epilepsy
• MRI evidence of potentially epileptogenic lesions outside the medial temporal lobe such as dysplasias, tumours or cavernomas
• Prior resective intracranial surgery
• Patients who are candidates for invasive video-EEG recording or have previously been investigated with invasive video-EEG recording
• Patients who previously underwent any other type of neurostimulation for treating epilepsy
• Patients who unable to fill in questionnaires and comply with protocol requirements
• Progressive neurological or medical conditions
• Medical or psychiatric conditions precluding surgery or compliance
• Patients taking antidepressant medication
• Pregnancy at study onset
• Previous (within the last 3 months), ongoing or planned participation in other treatment study protocols for epilepsy
• Contraindication for intracranial surgery
• Contraindication for Vagus Nerve Stimulation Therapy
• Patient has had a bilateral or left cervical vagotomy, currently uses, or is expected to use during the study, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy,
• A VNS Therapy System implant would (in the investigator's judgment) pose an unacceptable surgical or medical risk for the patient

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

the Department of Neurology, Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Epilepsy; Epilepsy, Temporal Lobe; Brain Diseases

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Epilepsies, Partial; Epileptic Syndromes

Study Officials

• Yanchun YC Deng, MD, PhD

  the Department of Neurology, Xijing Hospital

  STUDY DIRECTOR

Central Study Contacts

Yanchun YC Deng, MD. PhD.

CONTACT

+86 29 84773994; yanchund@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2013
• First Posted: March 17, 2014
• Study Start: June 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2017
• Last Updated: March 17, 2014

Record last verified: 2014-03

Locations

CN (1)