Study Comparing Best Medical Practice With or Without VNS Therapy in Pharmacoresistant Partial Epilepsy Patients
- Conditions
- Partial EpilepsyEpilepsy
- Interventions
- Drug: Best Medical PractiveDevice: Vagal Nerve Simulation (VNS) Therapy
- Registration Number
- NCT00522418
- Lead Sponsor
- Cyberonics, Inc.
- Brief Summary
This is a post-market medical device study. This study will compare best medical practice with or without adjunctive VNS Therapy in patients who are 16 years and older with pharmacoresistant partial epilepsy.
- Detailed Description
This is a post-market medical device study. This study will compare best medical practice with or without adjunctive VNS Therapy in patients who are 16 years and older with pharmaco-resistant partial epilepsy. The Sponsor, Cyberonics, provides funding for this study. Patients are followed for 26 months, 24 of those months are following the initiation of treatment. No study sites will be permitted to enroll study subjects until Institutional Review Board (IRB)/Ethics Committee (EC) approval has been received.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 122
- Patient has confirmed partial onset seizures.
- Seizure activity is not adequately controlled by patient's current AED regimen.
- Patient is between 16 and 75 years of age.
- Patient is able to give accurate seizure counts and health outcomes information. Patient is able to complete study instruments with minimal assistance.
- Patient has previously failed at least 3 AEDs in single or combination use.
- During baseline evaluation period, patient should take at least 1 AED.
- Patient should have confirmed epilepsy for a minimum of 2 years.
- Patient's AED regimen is stable for at least 1 month prior to enrolment.
- Patient has at least 1 objective partial onset seizure per month during the 2 months prior to enrolment.
- Patient or legal guardian understands study procedures and has voluntarily signed an informed consent in accordance with institutional and local regulatory policies.
- Patient has pseudoseizures or a history of pseudoseizures.
- Patient has idiopathic generalised epilepsy or unclassified epilepsy.
- Patient has ever received direct brain stimulation (cerebella or thalamic) for treatment of epilepsy.
- Patient has had a unilateral or bilateral cervical vagotomy.
- Patient has a history of non-compliance with the completion of a seizure diary.
- Patient has taken an investigational drug within a period of 3 months prior to inclusion.
- Patient is currently using another investigational medical device.
- Patient has a significant cardiac or pulmonary condition currently under treatment.
- Patient has previously undergone brain surgery.
- Patient has a demand cardiac pacemaker, implantable defibrillator, or other implantable stimulator.
- Patient currently lives more than 2 hours from the study site or plans to relocate to a location more than 2 hours from the study site within one year of enrolment in the Study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Best Medical Practice Best Medical Practive Best Medical Practice VNS Therapy Vagal Nerve Simulation (VNS) Therapy VNS Therapy + Best Medical Practice
- Primary Outcome Measures
Name Time Method Overall Quality of Life in Epilepsy-89 (QOLIE-89) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment Mean change from baseline QOLIE-89 Overall Score at 12 months QOLIE-89 contains 17 multi-item measures of overall quality of life, emotional well-being, role limitations due to emotional problems, social support, social isolation, energy/fatigue, worry about seizure, medication effects, health discouragement, work/driving/social function, attention/concentration, language, memory, physical function, pain, role limitations due to physical problems, and health perceptions. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life.
- Secondary Outcome Measures
Name Time Method Percent of Patients That Are Seizure Free 3, 6, 9, 12, 15, 18, 21, 24 months Percent of patients that are seizure free as defined by no seizures during the preceding follow-up period.
Change From Baseline in Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score Mean change from baseline NDDI-E Score at 12 months The Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) is a 6-item questionnaire validated to screen for depression in people with epilepsy. Scores range from 6 to 24, with higher scores indicating more depressive symptoms.
Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) in Patients With Less Then a 50% Reduction in Seizures At 12 and 24 months The Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) is a 6-item questionnaire validated to screen for depression in people with epilepsy. Scores range from 6 to 24, with higher scores indicating more depressive symptoms.
Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Score Mean change from baseline CES-D Score at 12 months The Center for Epidemiologic Studies Depression Scale (CES-D) includes 20 items comprising six scales reflecting major dimensions of depression: depressed mood, feelings of guilt and worthlessness, feelings of helplessness and hopelessness, psychomotor retardation, loss of appetite, and sleep disturbance. Possible range of scores is 0 to 60, higher scores indicate more depressive symptoms.
Treatment Emergent Adverse Events, Device Complications, and Premature Study Withdrawal At 12 and 24 months Number of participants with treatment emergent adverse events, device complications, and premature Study withdrawal.
Clinical Global Impressions Scale (CGI) in Patients With Less Then a 50% Reduction in Seizures At 12 and 24 months The Clinical Global Impression scale (CGI-I)is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention Scores range from 1-7: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
Response Rate Number of Responders at 12 Months Response Rate is defined as the percent of participants who are responders. A Responder is defined as participants with a reduction of at least 50% or 75% in seizure frequency from baseline to the seizure count evaluation period.
Mean Percent Change in Seizure Frequency Mean percent change from baseline in seizure frequency at 12 months Percent change in total seizuires per week from baseline at 12 months
Seizure Free Days Over the Last 6 Months Over the last 6 months Mean Change From Beginning of Intervention Clinical Global Impression-Improvement Scale (CGI-I) Score at 12 Months Mean change from baseline CGI-I Score at 12 months The Clinical Global Impression scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention Scores range from 1-7: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
Seizure Free Days From the patient's last seizure to the study exit date Seizure free days is defined as the time from last seizure to study exit date.
Change in the Number of Anti-epileptic Drugs Prescribed At 12 and 24 months Changes in Anti-Epileptic Drugs (AEDs) in patients with less then a 50% reduction in seizures
Change From Baseline in QOLIE-89 Measures: Subgroup Analysis of Population With Baseline Adverse Event Profile Score >= 40 Change from baseline up to 12 months QOLIE-89 contains 17 multi-item measures of overall quality of life. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life. Adverse Events Profile (AEP) is a 19-item scale used as a systematic measure of adverse effects from antiepileptic drugs (AEDs). Scores range from 19-76; higher scores indicate high prevelance and severity of adverse events.
Change From Baseline in Adverse Event Profile (AEP) Score Mean change from baseline AEP Score at 12 months Adverse Events Profile (AEP) is a 19-item scale used as a systematic measure of adverse effects from antiepileptic drugs (AEDs). Scores range from 19-76; higher scores indicate high prevelance and severity of adverse events.
Changes in Anti-epileptic Drugs (AEDs) Change from baseline in number of AEDs at 12 months Change from baseline in number of AED medications by visit
Retention Rate At 12 and 24 months Percent of participants who were compliant with the protocol.
Quality of Life in Epilepsy - 89 Items(QOLIE-89)in Patients With Less Than a 50% Reduction in Seizures At 12 and 24 months QOLIE-89 contains 17 multi-item measures of overall quality of life, emotional well-being, role limitations due to emotional problems, social support, social isolation, energy/fatigue, worry about seizure, medication effects, health discouragement, work/driving/social function, attention/concentration, language, memory, physical function, pain, role limitations due to physical problems, and health perceptions. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life.
Adverse Event Profile (AEP) in Patients With Less Then a 50% Reduction in Seizures At 12 and 24 months Adverse Events Profile (AEP) is a 19-item scale used as a systematic measure of adverse effects from antiepileptic drugs (AEDs). Scores range from 19-76; higher scores indicate high prevelance and severity of adverse events.
Centre for Epidemiologic Studies Depression Scale (CES-D) in Patients With Less Then a 50% Reduction At 12 and 24 months The Center for Epidemiologic Studies Depression Scale (CES-D) includes 20 items comprising six scales reflecting major dimensions of depression: depressed mood, feelings of guilt and worthlessness, feelings of helplessness and hopelessness, psychomotor retardation, loss of appetite, and sleep disturbance. Possible range of scores is 0 to 60, higher scores indicate more depressive symptoms.
Percent of Participants Who Were Compliant With the Protocol At 12 and 24 months Retention rate in patients with less then a 50% reduction in seizures
Change From Baseline in QOLIE-89 Measures: Subgroup Analysis of Population With Baseline Adverse Event Profile Score < 40 Change from baseline up to 12 months QOLIE-89 contains 17 multi-item measures of overall quality of life. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life. Adverse Events Profile (AEP) is a 19-item scale used as a systematic measure of adverse effects from antiepileptic drugs (AEDs). Scores range from 19-76; higher scores indicate high prevelance and severity of adverse events.
Trial Locations
- Locations (48)
ULB-Hôpital Erasme, Centre de référence pour le traitement de l'épilepsie réfractaire - Neurologie
🇧🇪Brussels, Belgium
UZ Gent, Department of Neurology, 1K12/A
🇧🇪Gent, Belgium
Foothills Hospital, Neurology Department
🇨🇦Calgary, Alberta, Canada
Hopital Notre Dame
🇨🇦Montreal, Quebec, Canada
QEII Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada
Montreal Neurological Institute, Clinical Research
🇨🇦Montreal, Quebec, Canada
CHU Grenoble, Neurology Department
🇫🇷Grenoble, France
Hopital Roger Salengro, Service de Neurologie
🇫🇷Lille, France
Hôpital Neurologique, Untité d'épileptologie
🇫🇷Lyon, France
Hôpital Sainte-Anne, Service de Neurochirurgie
🇫🇷Paris, France
Service d'exploration des épilepsies
🇫🇷Strasbourg, France
CHU Tours, Service de neurologie
🇫🇷Tours, France
Universitätskliniken Bonn, Klinik für Epileptologie
🇩🇪Bonn, Germany
Universitätsklinik Erlangen, Zentrum für Epilepsie ZEE
🇩🇪Erlangen, Germany
Klinik der Ernst-Moritz-Arndt-Universität, Neurologische Klinik
🇩🇪Greifswald, Germany
Epilepsiezentrum Kork
🇩🇪Kehl-Kork, Germany
Sächsisches Epilepsiezentrum Radeberg, Epilepsiezentrum Kleinwachau
🇩🇪Radeberg, Germany
Klinikum der Philips-Universität Marburg, Fachbereich, 20 - Medizin / Klinik Neurologie / Epilepsie Zentrum
🇩🇪Marburg, Germany
Azienda Ospedaliero Universitaria - Ospedali Riuniti Umberto I - Lancisi - Salesi, NeuroPsichiatria Infantile
🇮🇹Ancona, Italy
Universita di Bologna, Clinica Neurologica
🇮🇹Bologna, Italy
Azienda Ospendaliero-Universitaria, Caressi Dep Neuroscience
🇮🇹Firenze, Italy
Ospedale San Paolo, Centro Epilessia
🇮🇹Milano, Italy
Universita degli Studi di Cagliari - Policlinico Monserrato, Clinica Neurologica
🇮🇹Monserrato, Italy
Universita di Pisa, Clinica Neurologica
🇮🇹Pisa, Italy
Ospedale F. Lotti, NeuroFisioPatalogia
🇮🇹Pontedera, Italy
Azienda Ospedaliera "Bianchi Melacrino Morelli", Centro Regionale Epilessie
🇮🇹Reggio Calabria, Italy
Università Cattolica Del Sacro Cuore, Istituto di NeuroChirurgia
🇮🇹Roma, Italy
Kempenhaeghe, Dienst Neurologie
🇳🇱Oosterhout, Netherlands
Centro Epilessia, Dipartimento di Neuroscienze
🇮🇹Torino, Italy
Stichting Epilepsie Instituut Nederland, Dienst Neurologie
🇳🇱Heemstede, Netherlands
Medisch Centrum Rijnmond-Zuid, locatie Clara, Dienst Neurologie
🇳🇱Rotterdam, Netherlands
Spesialsykehuset for Epilepsi, Dep of Neurodiagnostics
🇳🇴Sandvika, Norway
Hospital Ruber Internacional, Servicio de neurología
🇪🇸Madrid, Spain
Hospital Clínico Universitario, Servicio de neurología
🇪🇸Valencia, Spain
Hospital Clínico de Santiago
🇪🇸Santiago de Compostela, Spain
Hospital General de Valencia, Neurology/Neurophisiology
🇪🇸Valencia, Spain
Hospital General Basico De La Defensa de Valencia, Servicio de neurología
🇪🇸Valencia, Spain
Institute of Neuroscience and Physiology, Clinical Neuroscience and Rehabilitation
🇸🇪Goteborg, Sweden
Universitetssjukhuset i Lund, Neurologiska kliniken
🇸🇪Lund, Sweden
Norrlands Universitetssjukhus, Neurocentrum
🇸🇪Umea, Sweden
Akademiska sjukhuset, Neurocentrum
🇸🇪Uppsala, Sweden
Walton Centre, Dept of Neurosciences, Clinical Sciences Centre
🇬🇧Fazakerley, United Kingdom
Addenbrookes Hospital, Dept of Neurosurgery
🇬🇧Cambridge, United Kingdom
Kings College Hospital, Dept of Neurosurgery
🇬🇧London, United Kingdom
National Hospital for Neurology and Neurosurgery
🇬🇧London, United Kingdom
Tergooiziekenhuizen, Dienst Neurologie
🇳🇱Blaricum, Netherlands
Medisch Spectrum Twente, Dienst Neurologie
🇳🇱Enschede, Netherlands
Hôpital Gui De Chauliac, Service Explorations Neurologiques et Epileptologie
🇫🇷Montpellier, France