Back to results

Study Comparing Best Medical Practice With or Without VNS Therapy in Pharmacoresistant Partial Epilepsy Patients

Primary Purpose

Epilepsy, Partial Epilepsy

Status

Terminated

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Vagal Nerve Simulation (VNS) Therapy

Best Medical Practive

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy, VNS Therapy

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

ULB-Hôpital Erasme, Centre de référence pour le traitement de l'épilepsie réfractaire - Neurologie
UZ Gent, Department of Neurology, 1K12/A
Foothills Hospital, Neurology Department
QEII Health Sciences Centre
Hopital Notre Dame
Montreal Neurological Institute, Clinical Research
CHU Grenoble, Neurology Department
Hopital Roger Salengro, Service de Neurologie
Hôpital Neurologique, Untité d'épileptologie
Hôpital Gui De Chauliac, Service Explorations Neurologiques et Epileptologie
Hôpital Sainte-Anne, Service de Neurochirurgie
Service d'exploration des épilepsies
CHU Tours, Service de neurologie
Universitätskliniken Bonn, Klinik für Epileptologie
Universitätsklinik Erlangen, Zentrum für Epilepsie ZEE
Klinik der Ernst-Moritz-Arndt-Universität, Neurologische Klinik
Epilepsiezentrum Kork
Klinikum der Philips-Universität Marburg, Fachbereich, 20 - Medizin / Klinik Neurologie / Epilepsie Zentrum
Sächsisches Epilepsiezentrum Radeberg, Epilepsiezentrum Kleinwachau
Azienda Ospedaliero Universitaria - Ospedali Riuniti Umberto I - Lancisi - Salesi, NeuroPsichiatria Infantile
Universita di Bologna, Clinica Neurologica
Azienda Ospendaliero-Universitaria, Caressi Dep Neuroscience
Ospedale San Paolo, Centro Epilessia
Universita degli Studi di Cagliari - Policlinico Monserrato, Clinica Neurologica
Universita di Pisa, Clinica Neurologica
Ospedale F. Lotti, NeuroFisioPatalogia
Azienda Ospedaliera "Bianchi Melacrino Morelli", Centro Regionale Epilessie
Università Cattolica Del Sacro Cuore, Istituto di NeuroChirurgia
Centro Epilessia, Dipartimento di Neuroscienze
Tergooiziekenhuizen, Dienst Neurologie
Medisch Spectrum Twente, Dienst Neurologie
Stichting Epilepsie Instituut Nederland, Dienst Neurologie
Kempenhaeghe, Dienst Neurologie
Medisch Centrum Rijnmond-Zuid, locatie Clara, Dienst Neurologie
Spesialsykehuset for Epilepsi, Dep of Neurodiagnostics
Hospital Ruber Internacional, Servicio de neurología
Hospital Clínico de Santiago
Hospital Clínico Universitario, Servicio de neurología
Hospital General de Valencia, Neurology/Neurophisiology
Hospital General Basico De La Defensa de Valencia, Servicio de neurología
Institute of Neuroscience and Physiology, Clinical Neuroscience and Rehabilitation
Universitetssjukhuset i Lund, Neurologiska kliniken
Norrlands Universitetssjukhus, Neurocentrum
Akademiska sjukhuset, Neurocentrum
Addenbrookes Hospital, Dept of Neurosurgery
Walton Centre, Dept of Neurosciences, Clinical Sciences Centre
Kings College Hospital, Dept of Neurosurgery
National Hospital for Neurology and Neurosurgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

VNS Therapy

Best Medical Practice

Arm Description

VNS Therapy + Best Medical Practice

Best Medical Practice

Outcomes

Primary Outcome Measures

Overall Quality of Life in Epilepsy-89 (QOLIE-89) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment

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

Response Rate

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.

Percent of Patients That Are Seizure Free

Percent of patients that are seizure free as defined by no seizures during the preceding follow-up period.

Mean Percent Change in Seizure Frequency

Percent change in total seizuires per week from baseline at 12 months

Seizure Free Days

Seizure free days is defined as the time from last seizure to study exit date.

Seizure Free Days Over the Last 6 Months

Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Score

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.

Change From Baseline in Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score

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.

Mean Change From Beginning of Intervention Clinical Global Impression-Improvement Scale (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.

Change From Baseline in Adverse Event Profile (AEP) Score

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 AED medications by visit

Retention Rate

Percent of participants who were compliant with the protocol.

Treatment Emergent Adverse Events, Device Complications, and Premature Study Withdrawal

Number of participants with treatment emergent adverse events, device complications, and premature Study withdrawal.

Quality of Life in Epilepsy - 89 Items(QOLIE-89)in Patients With Less Than a 50% Reduction in Seizures

Centre for Epidemiologic Studies Depression Scale (CES-D) in Patients With Less Then a 50% Reduction

Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) in Patients With Less Then a 50% Reduction in Seizures

Adverse Event Profile (AEP) in Patients With Less Then a 50% Reduction in Seizures

Change in the Number of Anti-epileptic Drugs Prescribed

Changes in Anti-Epileptic Drugs (AEDs) in patients with less then a 50% reduction in seizures

Percent of Participants Who Were Compliant With the Protocol

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

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 QOLIE-89 Measures: Subgroup Analysis of Population With Baseline Adverse Event Profile Score < 40

Clinical Global Impressions Scale (CGI) in Patients With Less Then a 50% Reduction in Seizures

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.

Full Information

NCT ID

NCT00522418

First Posted

August 27, 2007

Last Updated

January 9, 2015

Sponsor

Cyberonics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00522418

Brief Title

Study Comparing Best Medical Practice With or Without VNS Therapy in Pharmacoresistant Partial Epilepsy Patients

Official Title

An Open Prospective Randomised Long-Term Effectiveness Study, Comparing Best Medical Practice With or Without Adjunctive VNS Therapy in Patients 16 Years and Older With Pharmaco-resistant Partial Epilepsy

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Terminated

Why Stopped

Insufficient enrollment

Study Start Date

February 2006 (undefined)

Primary Completion Date

July 2008 (Actual)

Study Completion Date

July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cyberonics, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epilepsy, Partial Epilepsy

Keywords

Epilepsy, VNS Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

122 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VNS Therapy

Arm Type

Experimental

Arm Description

VNS Therapy + Best Medical Practice

Arm Title

Best Medical Practice

Arm Type

Active Comparator

Arm Description

Best Medical Practice

Intervention Type

Device

Intervention Name(s)

Vagal Nerve Simulation (VNS) Therapy

Intervention Description

VNS Therapy + Best Medical Practice including anti-epileptic drugs

Intervention Type

Drug

Intervention Name(s)

Best Medical Practive

Intervention Description

Best Medical Practice including anti-Epileptic Drugs

Primary Outcome Measure Information:

Title

Overall Quality of Life in Epilepsy-89 (QOLIE-89) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment

Description

Time Frame

Mean change from baseline QOLIE-89 Overall Score at 12 months

Secondary Outcome Measure Information:

Title

Response Rate

Description

Time Frame

Number of Responders at 12 Months

Title

Percent of Patients That Are Seizure Free

Description

Percent of patients that are seizure free as defined by no seizures during the preceding follow-up period.

Time Frame

3, 6, 9, 12, 15, 18, 21, 24 months

Title

Mean Percent Change in Seizure Frequency

Description

Percent change in total seizuires per week from baseline at 12 months

Time Frame

Mean percent change from baseline in seizure frequency at 12 months

Title

Seizure Free Days

Description

Seizure free days is defined as the time from last seizure to study exit date.

Time Frame

From the patient's last seizure to the study exit date

Title

Seizure Free Days Over the Last 6 Months

Time Frame

Over the last 6 months

Title

Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Score

Description

Time Frame

Mean change from baseline CES-D Score at 12 months

Title

Change From Baseline in Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score

Description

Time Frame

Mean change from baseline NDDI-E Score at 12 months

Title

Mean Change From Beginning of Intervention Clinical Global Impression-Improvement Scale (CGI-I) Score at 12 Months

Description

Time Frame

Mean change from baseline CGI-I Score at 12 months

Title

Change From Baseline in Adverse Event Profile (AEP) Score

Description

Time Frame

Mean change from baseline AEP Score at 12 months

Title

Changes in Anti-epileptic Drugs (AEDs)

Description

Change from baseline in number of AED medications by visit

Time Frame

Change from baseline in number of AEDs at 12 months

Title

Retention Rate

Description

Percent of participants who were compliant with the protocol.

Time Frame

At 12 and 24 months

Title

Treatment Emergent Adverse Events, Device Complications, and Premature Study Withdrawal

Description

Number of participants with treatment emergent adverse events, device complications, and premature Study withdrawal.

Time Frame

At 12 and 24 months

Title

Quality of Life in Epilepsy - 89 Items(QOLIE-89)in Patients With Less Than a 50% Reduction in Seizures

Description

Time Frame

At 12 and 24 months

Title

Centre for Epidemiologic Studies Depression Scale (CES-D) in Patients With Less Then a 50% Reduction

Description

Time Frame

At 12 and 24 months

Title

Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) in Patients With Less Then a 50% Reduction in Seizures

Description

Time Frame

At 12 and 24 months

Title

Adverse Event Profile (AEP) in Patients With Less Then a 50% Reduction in Seizures

Description

Time Frame

At 12 and 24 months

Title

Change in the Number of Anti-epileptic Drugs Prescribed

Description

Changes in Anti-Epileptic Drugs (AEDs) in patients with less then a 50% reduction in seizures

Time Frame

At 12 and 24 months

Title

Percent of Participants Who Were Compliant With the Protocol

Description

Retention rate in patients with less then a 50% reduction in seizures

Time Frame

At 12 and 24 months

Title

Change From Baseline in QOLIE-89 Measures: Subgroup Analysis of Population With Baseline Adverse Event Profile Score >= 40

Description

Time Frame

Change from baseline up to 12 months

Title

Change From Baseline in QOLIE-89 Measures: Subgroup Analysis of Population With Baseline Adverse Event Profile Score < 40

Description

Time Frame

Change from baseline up to 12 months

Title

Clinical Global Impressions Scale (CGI) in Patients With Less Then a 50% Reduction in Seizures

Description

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.

Time Frame

At 12 and 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Phillippe Ryvlin, MD

Organizational Affiliation

Hopital Neurologique, Lyon, France

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sophie Leyman, MD

Organizational Affiliation

Cyberonics Europe

Official's Role

Study Director

Facility Information:

Facility Name

ULB-Hôpital Erasme, Centre de référence pour le traitement de l'épilepsie réfractaire - Neurologie

City

Brussels

ZIP/Postal Code

1070

Country

Belgium

Facility Name

UZ Gent, Department of Neurology, 1K12/A

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Foothills Hospital, Neurology Department

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T1Y6J4

Country

Canada

Facility Name

QEII Health Sciences Centre

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 3A7

Country

Canada

Facility Name

Hopital Notre Dame

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2L 4M1

Country

Canada

Facility Name

Montreal Neurological Institute, Clinical Research

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3A 2B4

Country

Canada

Facility Name

CHU Grenoble, Neurology Department

City

Grenoble

ZIP/Postal Code

38043

Country

France

Facility Name

Hopital Roger Salengro, Service de Neurologie

City

Lille

ZIP/Postal Code

59037

Country

France

Facility Name

Hôpital Neurologique, Untité d'épileptologie

City

Lyon

ZIP/Postal Code

69003

Country

France

Facility Name

Hôpital Gui De Chauliac, Service Explorations Neurologiques et Epileptologie

City

Montpellier

ZIP/Postal Code

34295

Country

France

Facility Name

Hôpital Sainte-Anne, Service de Neurochirurgie

City

Paris

ZIP/Postal Code

75674

Country

France

Facility Name

Service d'exploration des épilepsies

City

Strasbourg

ZIP/Postal Code

67091

Country

France

Facility Name

CHU Tours, Service de neurologie

City

Tours

ZIP/Postal Code

37044

Country

France

Facility Name

Universitätskliniken Bonn, Klinik für Epileptologie

City

Bonn

ZIP/Postal Code

53105

Country

Germany

Facility Name

Universitätsklinik Erlangen, Zentrum für Epilepsie ZEE

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Klinik der Ernst-Moritz-Arndt-Universität, Neurologische Klinik

City

Greifswald

ZIP/Postal Code

17487

Country

Germany

Facility Name

Epilepsiezentrum Kork

City

Kehl-Kork

ZIP/Postal Code

77694

Country

Germany

Facility Name

Klinikum der Philips-Universität Marburg, Fachbereich, 20 - Medizin / Klinik Neurologie / Epilepsie Zentrum

City

Marburg

ZIP/Postal Code

35039

Country

Germany

Facility Name

Sächsisches Epilepsiezentrum Radeberg, Epilepsiezentrum Kleinwachau

City

Radeberg

ZIP/Postal Code

01465

Country

Germany

Facility Name

Azienda Ospedaliero Universitaria - Ospedali Riuniti Umberto I - Lancisi - Salesi, NeuroPsichiatria Infantile

City

Ancona

ZIP/Postal Code

60100

Country

Italy

Facility Name

Universita di Bologna, Clinica Neurologica

City

Bologna

ZIP/Postal Code

40123

Country

Italy

Facility Name

Azienda Ospendaliero-Universitaria, Caressi Dep Neuroscience

City

Firenze

ZIP/Postal Code

50100

Country

Italy

Facility Name

Ospedale San Paolo, Centro Epilessia

City

Milano

ZIP/Postal Code

20142

Country

Italy

Facility Name

Universita degli Studi di Cagliari - Policlinico Monserrato, Clinica Neurologica

City

Monserrato

ZIP/Postal Code

09042

Country

Italy

Facility Name

Universita di Pisa, Clinica Neurologica

City

Pisa

ZIP/Postal Code

56126

Country

Italy

Facility Name

Ospedale F. Lotti, NeuroFisioPatalogia

City

Pontedera

ZIP/Postal Code

56025

Country

Italy

Facility Name

Azienda Ospedaliera "Bianchi Melacrino Morelli", Centro Regionale Epilessie

City

Reggio Calabria

ZIP/Postal Code

89100

Country

Italy

Facility Name

Università Cattolica Del Sacro Cuore, Istituto di NeuroChirurgia

City

Roma

ZIP/Postal Code

00168

Country

Italy

Facility Name

Centro Epilessia, Dipartimento di Neuroscienze

City

Torino

ZIP/Postal Code

10126

Country

Italy

Facility Name

Tergooiziekenhuizen, Dienst Neurologie

City

Blaricum

ZIP/Postal Code

1261, AN

Country

Netherlands

Facility Name

Medisch Spectrum Twente, Dienst Neurologie

City

Enschede

ZIP/Postal Code

7513 R

Country

Netherlands

Facility Name

Stichting Epilepsie Instituut Nederland, Dienst Neurologie

City

Heemstede

ZIP/Postal Code

8025 BV

Country

Netherlands

Facility Name

Kempenhaeghe, Dienst Neurologie

City

Oosterhout

ZIP/Postal Code

4901 ZG

Country

Netherlands

Facility Name

Medisch Centrum Rijnmond-Zuid, locatie Clara, Dienst Neurologie

City

Rotterdam

ZIP/Postal Code

3078 HT

Country

Netherlands

Facility Name

Spesialsykehuset for Epilepsi, Dep of Neurodiagnostics

City

Sandvika

ZIP/Postal Code

1306

Country

Norway

Facility Name

Hospital Ruber Internacional, Servicio de neurología

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Hospital Clínico de Santiago

City

Santiago de Compostela

ZIP/Postal Code

15706

Country

Spain

Facility Name

Hospital Clínico Universitario, Servicio de neurología

City

Valencia

ZIP/Postal Code

46010

Country

Spain

Facility Name

Hospital General de Valencia, Neurology/Neurophisiology

City

Valencia

ZIP/Postal Code

46014

Country

Spain

Facility Name

Hospital General Basico De La Defensa de Valencia, Servicio de neurología

City

Valencia

ZIP/Postal Code

46930

Country

Spain

Facility Name

Institute of Neuroscience and Physiology, Clinical Neuroscience and Rehabilitation

City

Goteborg

ZIP/Postal Code

41345

Country

Sweden

Facility Name

Universitetssjukhuset i Lund, Neurologiska kliniken

City

Lund

ZIP/Postal Code

221 85

Country

Sweden

Facility Name

Norrlands Universitetssjukhus, Neurocentrum

City

Umea

ZIP/Postal Code

901 85

Country

Sweden

Facility Name

Akademiska sjukhuset, Neurocentrum

City

Uppsala

ZIP/Postal Code

751 85

Country

Sweden

Facility Name

Addenbrookes Hospital, Dept of Neurosurgery

City

Cambridge

ZIP/Postal Code

CB2 2QQ

Country

United Kingdom

Facility Name

Walton Centre, Dept of Neurosciences, Clinical Sciences Centre

City

Fazakerley

ZIP/Postal Code

L97LJ

Country

United Kingdom

Facility Name

Kings College Hospital, Dept of Neurosurgery

City

London

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

Facility Name

National Hospital for Neurology and Neurosurgery

City

London

ZIP/Postal Code

WC1N3B

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

11971128

Citation

Gilliam F. Optimizing health outcomes in active epilepsy. Neurology. 2002 Apr 23;58(8 Suppl 5):S9-20. doi: 10.1212/wnl.58.8_suppl_5.s9.

Results Reference

background

PubMed Identifier

10660394

Citation

Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000 Feb 3;342(5):314-9. doi: 10.1056/NEJM200002033420503.

Results Reference

background

PubMed Identifier

9624191

Citation

Sillanpaa M, Jalava M, Kaleva O, Shinnar S. Long-term prognosis of seizures with onset in childhood. N Engl J Med. 1998 Jun 11;338(24):1715-22. doi: 10.1056/NEJM199806113382402.

Results Reference

background

PubMed Identifier

3925335

Citation

Mattson RH, Cramer JA, Collins JF, Smith DB, Delgado-Escueta AV, Browne TR, Williamson PD, Treiman DM, McNamara JO, McCutchen CB, et al. Comparison of carbamazepine, phenobarbital, phenytoin, and primidone in partial and secondarily generalized tonic-clonic seizures. N Engl J Med. 1985 Jul 18;313(3):145-51. doi: 10.1056/NEJM198507183130303.

Results Reference

background

PubMed Identifier

1298221

Citation

Mattson RH, Cramer JA, Collins JF. A comparison of valproate with carbamazepine for the treatment of complex partial seizures and secondarily generalized tonic-clonic seizures in adults. The Department of Veterans Affairs Epilepsy Cooperative Study No. 264 Group. N Engl J Med. 1992 Sep 10;327(11):765-71. doi: 10.1056/NEJM199209103271104.

Results Reference

background

PubMed Identifier

8710127

Citation

Mattson RH, Cramer JA, Collins JF. Prognosis for total control of complex partial and secondarily generalized tonic clonic seizures. Department of Veterans Affairs Epilepsy Cooperative Studies No. 118 and No. 264 Group. Neurology. 1996 Jul;47(1):68-76. doi: 10.1212/wnl.47.1.68.

Results Reference

background

PubMed Identifier

12151114

Citation

Schmidt D. The clinical impact of new antiepileptic drugs after a decade of use in epilepsy. Epilepsy Res. 2002 Jun;50(1-2):21-32. doi: 10.1016/s0920-1211(02)00065-7.

Results Reference

background

PubMed Identifier

11114218

Citation

Lhatoo SD, Wong IC, Polizzi G, Sander JW. Long-term retention rates of lamotrigine, gabapentin, and topiramate in chronic epilepsy. Epilepsia. 2000 Dec;41(12):1592-6. doi: 10.1111/j.1499-1654.2000.001592.x.

Results Reference

background

PubMed Identifier

10563620

Citation

Morris GL 3rd, Mueller WM. Long-term treatment with vagus nerve stimulation in patients with refractory epilepsy. The Vagus Nerve Stimulation Study Group E01-E05. Neurology. 1999 Nov 10;53(8):1731-5. doi: 10.1212/wnl.53.8.1731. Erratum In: Neurology 2000 Apr 25;54(8):1712.

Results Reference

background

PubMed Identifier

11552020

Citation

Malow BA, Edwards J, Marzec M, Sagher O, Ross D, Fromes G. Vagus nerve stimulation reduces daytime sleepiness in epilepsy patients. Neurology. 2001 Sep 11;57(5):879-84. doi: 10.1212/wnl.57.5.879.

Results Reference

background

PubMed Identifier

12609137

Citation

Harden CL, Pulver MC, Ravdin LD, Nikolov B, Halper JP, Labar DR. A Pilot Study of Mood in Epilepsy Patients Treated with Vagus Nerve Stimulation. Epilepsy Behav. 2000 Apr;1(2):93-99. doi: 10.1006/ebeh.2000.0046.

Results Reference

background

PubMed Identifier

11074193

Citation

Elger G, Hoppe C, Falkai P, Rush AJ, Elger CE. Vagus nerve stimulation is associated with mood improvements in epilepsy patients. Epilepsy Res. 2000 Dec;42(2-3):203-10. doi: 10.1016/s0920-1211(00)00181-9.

Results Reference

background

PubMed Identifier

10195186

Citation

Clark KB, Naritoku DK, Smith DC, Browning RA, Jensen RA. Enhanced recognition memory following vagus nerve stimulation in human subjects. Nat Neurosci. 1999 Jan;2(1):94-8. doi: 10.1038/4600.

Results Reference

background

PubMed Identifier

12824707

Citation

McLachlan RS, Sadler M, Pillay N, Guberman A, Jones M, Wiebe S, Schneiderman J. Quality of life after vagus nerve stimulation for intractable epilepsy: is seizure control the only contributing factor? Eur Neurol. 2003;50(1):16-9. doi: 10.1159/000070853.

Results Reference

background

PubMed Identifier

11673017

Citation

Cramer JA, Ben Menachem E, French J. Review of treatment options for refractory epilepsy: new medications and vagal nerve stimulation. Epilepsy Res. 2001 Nov;47(1-2):17-25. doi: 10.1016/s0920-1211(01)00286-8.

Results Reference

background

PubMed Identifier

14718691

Citation

Gilliam FG, Fessler AJ, Baker G, Vahle V, Carter J, Attarian H. Systematic screening allows reduction of adverse antiepileptic drug effects: a randomized trial. Neurology. 2004 Jan 13;62(1):23-7. doi: 10.1212/wnl.62.1.23.

Results Reference

background

PubMed Identifier

24754318

Citation

Ryvlin P, Gilliam FG, Nguyen DK, Colicchio G, Iudice A, Tinuper P, Zamponi N, Aguglia U, Wagner L, Minotti L, Stefan H, Boon P, Sadler M, Benna P, Raman P, Perucca E. The long-term effect of vagus nerve stimulation on quality of life in patients with pharmacoresistant focal epilepsy: the PuLsE (Open Prospective Randomized Long-term Effectiveness) trial. Epilepsia. 2014 Jun;55(6):893-900. doi: 10.1111/epi.12611. Epub 2014 Apr 22. Erratum In: Epilepsia. 2014 Sep;55(9):1476. Epilepsia. 2015 Jun;56(6):983.

Results Reference

result

Learn more about this trial

Study Comparing Best Medical Practice With or Without VNS Therapy in Pharmacoresistant Partial Epilepsy Patients

We'll reach out to this number within 24 hrs