EpilepsyCoRaVNStiRNCT02089243
Controlled Randomized Vagus Nerve Stimulation (VNS) Therapy Versus Resection (CoRaVNStiR)
A study testing Vagus nerve stimulation therapy and Resective surgery in people with Epilepsy, run by Xijing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Vagus nerve stimulation therapy and Resective surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
the Department of Neurology, Xijing Hospital
Xi'an, Shaanxi, 710032
Yanchun YC Deng, MD, PhD, +86 29 84773994, yanchund@fmmu.edu.cn
About this study
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)
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.
Read the 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
- Being tested
- Vagus nerve stimulation therapy, Resective surgery
- Keywords
- Epilepsy,Temporal Lobe, Brain Diseases
- Medical subject headings
- Epilepsy, Epilepsy, Temporal Lobe, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagus nerve stimulation therapyProcedure or surgery
The adjustments in device parameters were performed, individually, and solely at the discretion of the primary epileptologist with a formal protocol guiding changes.
Resective surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Resective surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
seizure frequency
Measured: 3 months
Secondary outcomes (6)
neuropsychological examination
Measured: 12 months
responder rates
Measured: during 3 month intervals
mean seizure free interval
Measured: during 3 month intervals
seizure severity
Measured: during 3-month intervals
quality of life
Measured: 3 months, 6 months, 9 months and 12 months
complications
Measured: during twelve months after inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startJun 2014
- Primary completionJul 2016 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yanchun YC Deng, MD, PhD, Study director, the Department of Neurology, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02089243
- Sponsor's protocol ID
- xijing-009
- Acronym
- CoRaVNStiR
- Status last verified
- Mar 2014
- First submitted
- 10 Apr 2013
- Last updated
- 17 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02089243
- Acronym / sponsor ID
- CoRaVNStiR / xijing-009
- Conditions
- Epilepsy
- Keywords
- Epilepsy,Temporal Lobe, Brain Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 17 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vagus nerve stimulation therapy | Experimental | Procedure: Vagus nerve stimulation therapySurgical 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. |
| Resective surgery | Experimental | Procedure: Resective surgeryThe 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. |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vagus nerve stimulation therapyThe adjustments in device parameters were performed, individually, and solely at the discretion of the primary epileptologist with a formal protocol guiding changes. | Procedure or surgery | Vagus nerve stimulation therapy |
| Resective surgeryThe 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. | Procedure or surgery | Resective surgery |
Primary outcome
seizure frequency
Time frame: 3 months
6 secondary outcomes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2014.
Related trials for Epilepsy
Enrolling by invitation
Neural Mechanisms for Stopping Ongoing Speech Production (Study 2)
Epilepsy, Speech
Recruiting
Identification of Biomarkers for Vagus Nerve Stimulation in Patients With Refractory Epilepsy
Refractory Epilepsy
RecruitingObservational study
Tumor Related Epilepsy
Epilepsy, Cancer
RecruitingObservational study
Evaluation and Treatment of Neurosurgical Disorders
Neurologic Disorders
Active, not recruitingPhase 2
A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy
Focal Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanchun YC Deng, MD, PhD study director
the Department of Neurology, Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vagus nerve stimulation therapy and Resective surgery in people with Epilepsy, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanchun YC Deng, MD. PhD. (+86 29 84773994, yanchund@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
seizure frequency (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2014.