Seizure Detection and Automatic Magnet Mode Performance Study (E-36)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
PRA Health Sciences
Information provided by (Responsible Party):
Cyberonics, Inc.
ClinicalTrials.gov Identifier:
NCT01325623
First received: March 23, 2011
Last updated: October 20, 2014
Last verified: October 2014

March 23, 2011
October 20, 2014
March 2011
July 2013   (final data collection date for primary outcome measure)
Seizure Detection Performance evaluation of the Model 106 VNS Therapy® System [ Time Frame: up to 26 months ] [ Designated as safety issue: No ]
The primary study objective is to evaluate the Model 106 VNS Therapy® System cardiac-based seizure detection and Automatic Magnet Mode (AMM) stimulation in epilepsy patients.
Algorithm Detection Performance evaluation of the Model 106 VNS Therapy® System [ Time Frame: Evaluation of the seizure detection and AMM stimulation will be completed March 2012 (1 yr) ] [ Designated as safety issue: No ]
The primary study objective is to evaluate the Model 106 VNS Therapy® System cardiac-based seizure detection and Automated Magnet Mode (AMM) stimulation in epilepsy patients. These two new features will be evaluated using continuous observational video electroencephalogram (vEEG) and electrocardiogram (ECG) data in ictal and non-ictal events during an Epilepsy Monitoring Unit (EMU) stay.
Complete list of historical versions of study NCT01325623 on ClinicalTrials.gov Archive Site
  • Assess stimulation-related adverse event rates to outline the tolerability profile of Model 106 device. [ Time Frame: up to 26 months ] [ Designated as safety issue: No ]
  • Evaluation of human factors and usability of the system. [ Time Frame: up to 26 months ] [ Designated as safety issue: No ]
  • Assess Characterization of Seizures [ Time Frame: up to 26 months ] [ Designated as safety issue: No ]
  • Assess changes from baseline in quality of life [ Time Frame: up to 26 months ] [ Designated as safety issue: No ]
  • Latency [ Time Frame: Timing of detection will be completed December 2012 (21 months) ] [ Designated as safety issue: No ]
    Timing of detection will also be assessed as latency between the seizure onset (either clinical or electroencephalographic, whichever comes first) and the time of AMM stimulation.
  • Characterization of cardiac R-wave detection behavior over time. [ Time Frame: Characterization of R-wave detection behavior will be completed December 2012 (21 months) ] [ Designated as safety issue: No ]
    During the implant procedure, patient heart rates will be calculated using detected R-waves from the Implantable Pulse Generator (IPG) and from a standard ECG monitor during a pre-specified time interval. R-wave detection will also be evaluated postoperatively when the patient awakens, during the titration visit, and during the EMU stay. See Appendix E. ECG Data Collection for more information.
  • Evaluation of new parameters such as post-stimulation refractory period. [ Time Frame: Evaluation of new parameters will be completed December 2012 (21 months) ] [ Designated as safety issue: No ]
    At the beginning of the EMU stay, 60 minutes of Normal Mode VNS stimulation will be recorded on vEEG and ECG. This data will be used to evaluate heart rate changes during stimulation and optimize recommendations for the post-stimulation refractory period setting. See Section VIII.A.4 for more information.
  • Evaluation of human factors and usability of the system. [ Time Frame: Evaluation of human factors and usability of the testing system will be completed December 2012 (21 months) ] [ Designated as safety issue: No ]
    A Usability Survey will be collected from all site personnel who use the handheld programmer to evaluate the usability of the Model 106 VNS Therapy System.
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Seizure Detection and Automatic Magnet Mode Performance Study
Seizure Detection and Automatic Magnet Mode Performance Study

The purpose of this study is to confirm cardiac-based seizure detection in Cyberonics Model 106 VNS Therapy System.

Prospective, observational, unblinded, multi-site study designed to collect data on patients implanted with a Model 106 VNS Therapy System from baseline through an EMU stay of up to 5 days. After the EMU stay, patients will continue follow-up for safety for approximately two years or until final regulatory approval of the product.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

Epileptics

Epilepsy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
35
August 2015
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with a clinical diagnosis of medically refractory epilepsy dominated by partial seizures suitable for implantation with the Model 106 VNS Therapy System.
  • Patients willing to undergo an EMU evaluation for a period of at least three days with activation of the AMM feature during that time.
  • Patients must be at least 18 years old.
  • Patients must be in good general health and ambulatory.
  • Patient or guardian must be willing and able to complete informed consent.

Exclusion Criteria:

  • Patients have had a bilateral or left cervical vagotomy.
  • Patients currently use, or are expected to use, 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.
  • Patients expected to require full body magnetic resonance imaging.
  • Patients have a history of VNS Therapy.
  • Patients with a significant psychiatric disorder, significant cognitive impairment, history of major depression, or suicidality as defined by DSM IV-TR that in the investigator's judgment would pose an unacceptable risk for the patient or prevent the patient's successful completion of the study.
  • Patients with a history of status epileptic within 3 months of study enrollment.
  • Patients with known clinically meaningful cardiovascular arrhythmias as well as patients with clinically meaningful cardiovascular arrhythmias determined by a 24-hour Holter recording obtained at the baseline visit.
  • Patients dependent on alcohol or narcotic drugs as defined by DSM IV-TR within the past 2 years.
  • Patients with a history of only psychogenic or pseudo seizures.
  • Women who are pregnant. Women of childbearing age must take a pregnancy test.
  • Patients currently enrolled in another investigational study.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Belgium,   United Kingdom,   Netherlands,   Norway
 
NCT01325623
Epilepsy (E)-36
Yes
Cyberonics, Inc.
Cyberonics, Inc.
PRA Health Sciences
Study Director: Bryan Olin Cyberonics, Inc.
Principal Investigator: Paul Boon Universitair Ziekenhuis Gent
Cyberonics, Inc.
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP