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

This study has been completed.
Sponsor:
Collaborator:
PRA Health Sciences
Information provided by (Responsible Party):
Cyberonics, Inc.
ClinicalTrials.gov Identifier:
NCT01325623
First received: March 23, 2011
Last updated: December 21, 2015
Last verified: December 2015
Results First Received: December 21, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Epilepsy
Intervention: Device: Model 106 VNS Therapy System

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Eligible subjects were at least 18 years old, with a clinical diagnosis of medically refractory epilepsy dominated by partial seizures suitable for implantation with the Model 106 VNS Therapy System and a history of ictal tachycardia, defined as heart rate above 100 bpm during a seizure and at least a 55% increase or 35 bpm increase from baseline.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 35 subjects were screened; (4) did not meet study criteria, (31) were treated/implanted with the AspireSR® VNS Therapy® System, of which (1) was implanted with version 1 of the AspireSR® VNS Therapy® System and (30) were implanted with version 2 (= ITT population).

Reporting Groups
  Description
Enrolled and Treated Population (Safety Population)

Consists of all patients who provided consent and were implanted with the AspireSR VNS Therapy System version 1 or version 2. The safety population will be used for all safety analyses. (N=31 subjects).

In version 2 of the AspireSR VNS Therapy System, the TVS diodes (present in version 1) were removed from the electrical circuit to address the accumulation of electrical charge on the sensing node (e.g. generator-can) following delivery of a stimulation.


Participant Flow:   Overall Study
    Enrolled and Treated Population (Safety Population)  
STARTED     31  
COMPLETED     28  
NOT COMPLETED     3  
Withdrawal by Subject                 3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects who provided consent and were implanted with the AspireSR VNS Therapy System version 1 or version 2.

Reporting Groups
  Description
VNS Therapy (Safety Population) The safety population consists of all patients who provided consent and were implanted with the AspireSR VNS Therapy System version 1 or version 2.

Baseline Measures
    VNS Therapy (Safety Population)  
Number of Participants  
[units: participants]
  31  
Age  
[units: years]
Mean (Standard Deviation)
  39.6  (13.4)  
Age, Customized  
[units: years]
Median (Full Range)
  38   (19 to 66)  
Age, Customized  
[units: participants]
 
18-29 years     10  
30-39 years     8  
40-49 years     5  
50-59 years     5  
60 years or older     3  
Gender  
[units: participants]
 
Female     19  
Male     12  
Race/Ethnicity, Customized  
[units: participants]
 
White     31  
Other     0  
Region of Enrollment  
[units: participants]
 
Netherlands     3  
Belgium     10  
Norway     1  
United Kingdom     7  
Germany     10  
Cognitive Status  
[units: participants]
 
Normal     20  
Minimal Impairment     8  
Moderate Impairment     3  
Severe Impairment     0  
Age at Epilepsy Onset  
[units: years]
Median (Full Range)
  14   (2 to 43)  
Age at Epilepsy Onset  
[units: years]
Mean (Standard Deviation)
  15.9  (10.9)  
Previous Brain or Epilepsy Surgery  
[units: participants]
 
    22  
Yes     9  
Etiology  
[units: participants]
 
Idiopathic     3  
Symptomatic     16  
Cryptogenic     12  
Family History of Seizures  
[units: participants]
 
    24  
Yes     7  
Seizures with Auras in the Past 2 Months  
[units: participants]
 
    15  
Yes     16  



  Outcome Measures
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1.  Primary:   Summary of Seizures Reported by Investigators and Triple Review   [ Time Frame: Epilepsy Monitoring Unit Stay ]

2.  Primary:   Observed Sensitivity Based on Heart Rate Increase Associated With Seizures by Randomized SDA Setting   [ Time Frame: Epilepsy Monitoring Unit (EMU) Stay ]

3.  Primary:   Modeled Sensitivity Based on Heart Rate Increase Associated With Seizures by SDA Setting Post-Processed Through Bench-top Device Simulant   [ Time Frame: Epilepsy Monitoring Unit (EMU) Stay ]

4.  Primary:   Potential False Positives Based on Heart Rate Increase Associated With Seizures by Randomized SDA Setting   [ Time Frame: Epilepsy Monitoring Unit (EMU) Stay ]

5.  Secondary:   Validation of Cardiac R-Wave Detection   [ Time Frame: At Implant, First Titration Visit, Day 1 EMU and 12 Months ]

6.  Secondary:   Characterization of Latency Period: Analysis of Observed Latency for True Positive Detections by Randomized SDA Setting   [ Time Frame: Epilepsy Monitoring Unit (EMU) Stay ]

7.  Secondary:   Human Factors and Usability of the AspireSR® VNS Therapy® System.   [ Time Frame: At implant/recovery up to EMU Discharge (2 to 4 weeks) ]

8.  Secondary:   Changes From Baseline in Seizure Frequency   [ Time Frame: Up to 24 Month visit ]

9.  Secondary:   Changes in Seizure Severity Based on Physician Reported Questionnaire (NHS3)   [ Time Frame: up to 24 Months Visit ]

10.  Secondary:   Changes in Seizures Severity, Intensity & Post-Ictal Recovery Based on Patient Completed Seizure Severity Questionnaire (SSQ)   [ Time Frame: Up to 24 Month visit ]

11.  Secondary:   Proportion of Seizures Ending During Stimulation by Type   [ Time Frame: Epilepsy Monitoring Unit (EMU) Stay ]

12.  Secondary:   Summary of Seizure Duration (Seconds) for All Seizure Types by Subgroup(ITT Population) (Only Seizures With Post Ictal Duration (Seconds) Annotated)   [ Time Frame: Historical Seizures and Seizures during Epilepsy Monitoring Unit Stay ]

13.  Secondary:   Summary of Post Ictal Duration (Seconds) for All Seizure Types (ITT Population) (Only Seizures With Post Ictal Duration (Seconds) Annotated)   [ Time Frame: Historical Seizures and Seizures during Epilepsy Monitoring Unit Stay ]

14.  Secondary:   Changes in Quality of Life on Patient Reported Questionnaire (QOLIE-31-P)   [ Time Frame: up to 24 Months Visit ]

15.  Secondary:   Overall Summary of Seizure Intensity by Subgroup   [ Time Frame: Historical Seizures and Seizures during Epilepsy Monitoing Unit Stay ]

16.  Secondary:   Post-stimulation Heart Rate Changes   [ Time Frame: EMU stay ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Wim Van Grunderbeek, Clinical Operations Manager Cyberonics Europe
Organization: Cyberonics Europe BVBA
phone: +32 2 720 95 93 ext 312
e-mail: wim.vangrunderbeek@cyberonics.com


Publications of Results:

Responsible Party: Cyberonics, Inc.
ClinicalTrials.gov Identifier: NCT01325623     History of Changes
Other Study ID Numbers: Epilepsy (E)-36
Study First Received: March 23, 2011
Results First Received: December 21, 2015
Last Updated: December 21, 2015
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products