Back to resultsNeurostimulation to the Vagus Nerve for the Reduction in Frequency of Seizures Associated With Epilepsy
Primary Purpose
Seizure
Status
Terminated
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
gammaCore
Sponsored by
About this trial
This is an interventional prevention trial for Seizure focused on measuring vagus nerve stimulation, vagal nerve stimulation, nVNS, VNS, epilepsy, non invasive, gammacore
Eligibility Criteria
Inclusion Criteria:
- The patient is diagnosed with epilepsy with; primary generalized tonic-clonic or partial complex or simple complex or focal onset seizures, with or without secondary generalization.
- The patient's present antiepileptic drug (AED) therapy is ineffective or intolerable
- The patient is receiving a stable dose of up to 2 oral AED medication(s) and is not expected to have any change in his/her baseline AED treatment during the treatment period.
- The patient is having more than 2 recordable seizures a month.
Exclusion Criteria:
- The patient has had status epilepticus within the last six months.
- The patient has had epilepsy surgery or a VNS implant.
- The patient has had a history or presence of seizures occurring only in clusters (too frequently or indistinctly separated to be reliably counted).
- The patient has had 4 weeks continuous seizure freedom last 2 months.
- The patient has psychogenic non-epileptic seizures (PNES) seizures.
- The patient has a concomitant progressive CNS disease including progressive myoclonus epilepsy.
- The patient has a significant history of cardiac, renal, neurologic (other than epilepsy), psychiatric, oncologic, endocrinologic, metabolic, or hepatic disease, which would adversely affect their participation in this study.
- The patient has had an episode of status epilepticus within 4 weeks of Screening.
10. Has a lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal anatomy at the GammaCore treatment site.
11. Has known or suspected severe atherosclerotic cardiovascular disease, severe carotid artery disease (e.g. bruits or history of TIA or CVA), congestive heart failure (CHF), known severe coronary artery disease or recent myocardial infarction.
12. Has an abnormal baseline ECG (e.g. second and third degree heart block, atrial fibrillation, atrial flutter, recent history of ventricular tachycardia or ventricular fibrillation, or clinically significant premature ventricular contraction).
13. Has had a previous bilateral, right, or left cervical vagotomy. 14. Has uncontrolled high blood pressure. 15. Is currently implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant.
16. Has a history of carotid endarterectomy or vascular neck surgery on the right side.
17. Has been implanted with metal cervical spine hardware or has a metallic implant near the GammaCore stimulation site.
18. Has a recent or repeated history of syncope. 19. Has a known history or suspicion of substance abuse or addiction. 20. In the opinion of the investigator/research staff the subject is incapable of operating the GammaCore device as intended and performing the data collection procedures.
21. Is pregnant, nursing, thinking of becoming pregnant in the next 9 months, or of childbearing years and is unwilling to use an accepted form of birth control.
Sites / Locations
- Southern Neurology
- Strategic Health Evaluators
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
gammaCore
sham gammaCore
Arm Description
Active stimulation treatment
Inactive stimulation treatment
Outcomes
Primary Outcome Measures
Frequency of Seizures
The seizure frequency was collected in the subject diary throughout Intervention 1/Phase 2 (8 weeks) and Intervention 2/Phase 3 (8 weeks).
Secondary Outcome Measures
Duration of Seizure
Duration of seizure was recorded by the subject in the subject diary throughout Intervention 1/Phase 2 (8 weeks) and Intervention 2/Phase 3 (8 weeks).
Severity of Seizure
The Seizure Severity Questionnaire (SSQ) is a self-reported assessment tool, which categorizes seizures into three phases: warning, ictal activity and postictal recovery. The recovery phase is subdivided into three components (cognitive, emotional and physical aspects of recovery), each of which is rated for frequency, severity and bothersome. Overall assessment of seizure severity is measured with the last two items.
Items are positively scored from a scale of 1-7, with lower scores representing a better status. 1 = none, never or mild and 7 = extremely frequent, severe or high.
The severity was reported for seizures occuring throughout Intervention 1/Phase 2 (8 weeks) and Intervention 2/Phase 3 (8 weeks).
Type of Adverse Events
Type of adverse events were split in to Adverse Events, Adverse Device Effects and Serious Adverse Events. Adverse events were reported throughout Intervention 1/Phase 2 (8 weeks) and Intervention 2/Phase 3 (8 weeks).
For frequency see the Adverse Event Table.
Number of Seizure Free Days
The number of seizure-free days was collected from the subjects' diary. The total number of days observed days for each phase and the total number of seizure free days for each phase are presented for the course of the study throughout Intervention 1/Phase 2 (8 weeks) and Intervention 2/Phase 3 (8 weeks).
Quality of Life in Epilepsy
The Quality of Life in Epilepsy-31 (QOLIE-31) instrument is a self- administered questionnaire. It includes seven subscales: Overall Quality of Life, Seizure Worry, Emotional Well-Being, Energy/Fatigue, Cognitive, Medication Effects, and Social Function. Questions 1-30 can yield seven individual scores (per subtest) and a total (composite) score. Higher scores indicate better QOL with values ranging from 1 to 100.
Question 31 is a subjective assessment of one's general health condition.Higher scores indicate a better-reported general health condition with the range being 1-10.
Scores are presented at end of Intervention 1/Phase 2 (8 weeks) and at the end of Intervention 2/Phase 3 (8 weeks).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01910129
Brief Title
Neurostimulation to the Vagus Nerve for the Reduction in Frequency of Seizures Associated With Epilepsy
Official Title
A Randomized, Multi-center, Double-blind, Parallel, Crossover Study of a Non-invasive Neurostimulation to the Vagus Nerve With the gammaCore Device for the Reduction in Frequency of Seizures Associated With Epilepsy.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment
Study Start Date
July 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ElectroCore INC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to see the effects of non-invasive vagal nerve stimulation for the reduction in frequency of seizure associated with epilepsy in subjects 18 or older.
Detailed Description
The purpose of the study is to determine the effects of non-invasive vagus nerve stimulation for the reduction in frequency of seizure associated with epilepsy in subjects 18 or older. Subjects will record 4 weeks of baseline seizure activity before being randomized for a period of 8 weeks to receive and active treatment to an active-sham treatment. All subjects will then receive another 8 weeks of active treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seizure
Keywords
vagus nerve stimulation, vagal nerve stimulation, nVNS, VNS, epilepsy, non invasive, gammacore
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
gammaCore
Arm Type
Active Comparator
Arm Description
Active stimulation treatment
Arm Title
sham gammaCore
Arm Type
Placebo Comparator
Arm Description
Inactive stimulation treatment
Intervention Type
Device
Intervention Name(s)
gammaCore
Intervention Description
vagal verve stimulation 3 times a day 8 hours apart
Primary Outcome Measure Information:
Title
Frequency of Seizures
Description
The seizure frequency was collected in the subject diary throughout Intervention 1/Phase 2 (8 weeks) and Intervention 2/Phase 3 (8 weeks).
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Duration of Seizure
Description
Duration of seizure was recorded by the subject in the subject diary throughout Intervention 1/Phase 2 (8 weeks) and Intervention 2/Phase 3 (8 weeks).
Time Frame
16 weeks
Title
Severity of Seizure
Description
The Seizure Severity Questionnaire (SSQ) is a self-reported assessment tool, which categorizes seizures into three phases: warning, ictal activity and postictal recovery. The recovery phase is subdivided into three components (cognitive, emotional and physical aspects of recovery), each of which is rated for frequency, severity and bothersome. Overall assessment of seizure severity is measured with the last two items.
Items are positively scored from a scale of 1-7, with lower scores representing a better status. 1 = none, never or mild and 7 = extremely frequent, severe or high.
The severity was reported for seizures occuring throughout Intervention 1/Phase 2 (8 weeks) and Intervention 2/Phase 3 (8 weeks).
Time Frame
16 weeks
Title
Type of Adverse Events
Description
Type of adverse events were split in to Adverse Events, Adverse Device Effects and Serious Adverse Events. Adverse events were reported throughout Intervention 1/Phase 2 (8 weeks) and Intervention 2/Phase 3 (8 weeks).
For frequency see the Adverse Event Table.
Time Frame
16 weeks
Title
Number of Seizure Free Days
Description
The number of seizure-free days was collected from the subjects' diary. The total number of days observed days for each phase and the total number of seizure free days for each phase are presented for the course of the study throughout Intervention 1/Phase 2 (8 weeks) and Intervention 2/Phase 3 (8 weeks).
Time Frame
16 weeks
Title
Quality of Life in Epilepsy
Description
The Quality of Life in Epilepsy-31 (QOLIE-31) instrument is a self- administered questionnaire. It includes seven subscales: Overall Quality of Life, Seizure Worry, Emotional Well-Being, Energy/Fatigue, Cognitive, Medication Effects, and Social Function. Questions 1-30 can yield seven individual scores (per subtest) and a total (composite) score. Higher scores indicate better QOL with values ranging from 1 to 100.
Question 31 is a subjective assessment of one's general health condition.Higher scores indicate a better-reported general health condition with the range being 1-10.
Scores are presented at end of Intervention 1/Phase 2 (8 weeks) and at the end of Intervention 2/Phase 3 (8 weeks).
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient is diagnosed with epilepsy with; primary generalized tonic-clonic or partial complex or simple complex or focal onset seizures, with or without secondary generalization.
The patient's present antiepileptic drug (AED) therapy is ineffective or intolerable
The patient is receiving a stable dose of up to 2 oral AED medication(s) and is not expected to have any change in his/her baseline AED treatment during the treatment period.
The patient is having more than 2 recordable seizures a month.
Exclusion Criteria:
The patient has had status epilepticus within the last six months.
The patient has had epilepsy surgery or a VNS implant.
The patient has had a history or presence of seizures occurring only in clusters (too frequently or indistinctly separated to be reliably counted).
The patient has had 4 weeks continuous seizure freedom last 2 months.
The patient has psychogenic non-epileptic seizures (PNES) seizures.
The patient has a concomitant progressive CNS disease including progressive myoclonus epilepsy.
The patient has a significant history of cardiac, renal, neurologic (other than epilepsy), psychiatric, oncologic, endocrinologic, metabolic, or hepatic disease, which would adversely affect their participation in this study.
The patient has had an episode of status epilepticus within 4 weeks of Screening.
10. Has a lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal anatomy at the GammaCore treatment site.
11. Has known or suspected severe atherosclerotic cardiovascular disease, severe carotid artery disease (e.g. bruits or history of TIA or CVA), congestive heart failure (CHF), known severe coronary artery disease or recent myocardial infarction.
12. Has an abnormal baseline ECG (e.g. second and third degree heart block, atrial fibrillation, atrial flutter, recent history of ventricular tachycardia or ventricular fibrillation, or clinically significant premature ventricular contraction).
13. Has had a previous bilateral, right, or left cervical vagotomy. 14. Has uncontrolled high blood pressure. 15. Is currently implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant.
16. Has a history of carotid endarterectomy or vascular neck surgery on the right side.
17. Has been implanted with metal cervical spine hardware or has a metallic implant near the GammaCore stimulation site.
18. Has a recent or repeated history of syncope. 19. Has a known history or suspicion of substance abuse or addiction. 20. In the opinion of the investigator/research staff the subject is incapable of operating the GammaCore device as intended and performing the data collection procedures.
21. Is pregnant, nursing, thinking of becoming pregnant in the next 9 months, or of childbearing years and is unwilling to use an accepted form of birth control.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy Beran, Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern Neurology
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Strategic Health Evaluators
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2067
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The study was prematurely discontinued
Learn more about this trial
Neurostimulation to the Vagus Nerve for the Reduction in Frequency of Seizures Associated With Epilepsy
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