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

Primary Purpose

Epilepsy

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Vagus nerve stimulation therapy
Resective surgery
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy,Temporal Lobe, Brain Diseases

Eligibility Criteria

12 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Patient is expected to require full body magnetic resonance imaging during the clinical study
  • Patient has had a previous VNS Therapy System implant.

Sites / Locations

  • the Department of Neurology, Xijing Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Vagus nerve stimulation therapy

Resective surgery

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

seizure frequency

Secondary Outcome Measures

neuropsychological examination
responder rates
mean seizure free interval
seizure severity
quality of life
complications

Full Information

First Posted
April 10, 2013
Last Updated
March 13, 2014
Sponsor
Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02089243
Brief Title
Controlled Randomized Vagus Nerve Stimulation (VNS) Therapy Versus Resection (CoRaVNStiR)
Acronym
CoRaVNStiR
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 Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy,Temporal Lobe, Brain Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vagus nerve stimulation therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Resective surgery
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Vagus nerve stimulation therapy
Intervention Description
The adjustments in device parameters were performed, individually, and solely at the discretion of the primary epileptologist with a formal protocol guiding changes.
Intervention Type
Procedure
Intervention Name(s)
Resective surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
seizure frequency
Time Frame
3 months
Secondary Outcome Measure Information:
Title
neuropsychological examination
Time Frame
12 months
Title
responder rates
Time Frame
during 3 month intervals
Title
mean seizure free interval
Time Frame
during 3 month intervals
Title
seizure severity
Time Frame
during 3-month intervals
Title
quality of life
Time Frame
3 months, 6 months, 9 months and 12 months
Title
complications
Time Frame
during twelve months after inclusion.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 Patient is expected to require full body magnetic resonance imaging during the clinical study Patient has had a previous VNS Therapy System implant.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanchun YC Deng, MD. PhD.
Phone
+86 29 84773994
Email
yanchund@fmmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanchun YC Deng, MD, PhD
Organizational Affiliation
the Department of Neurology, Xijing Hospital
Official's Role
Study Director
Facility Information:
Facility Name
the Department of Neurology, Xijing Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanchun YC Deng, MD, PhD
Phone
+86 29 84773994
Email
yanchund@fmmu.edu.cn

12. IPD Sharing Statement

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

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