RNS® System Feasibility Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NeuroPace
ClinicalTrials.gov Identifier:
NCT00079781
First received: March 12, 2004
Last updated: December 23, 2013
Last verified: December 2013
Results First Received: November 6, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Epilepsy
Interventions: Procedure: RNS® System implantation
Device: RNS® System responsive stimulation

  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
Subjects were recruited at Level 4 epilepsy centers, as categorized by the National Association of Epilepsy Centers (NAEC), through the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In order to undergo initial implant, subjects were required to have successfully completed the non-significant risk Prospective Seizure Frequency (PSF) study, which gathered baseline characteristics and data including (pre-implant) seizure frequency. Subjects were required to maintain a minimum seizure frequency and remain on the same AED regimen.

Reporting Groups
  Description
Open Label Group Group of subjects who underwent RNS® System implantation who were not randomized or blinded to therapy status during the Evaluation Period. Stimulation may have been enabled during the first month post-implant and may have continued throughout the subject's participation in the study.
Treatment Group Group of subjects who underwent RNS® System implantation who were randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the blinded Evaluation Period. Stimulation was enabled during the first month post-implant and may have continued throughout the subject's participation in the study.
Sham Group Group of subjects who underwent RNS® System implantation who were randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the blinded Evaluation Period. Stimulation may have been enabled after transition into the Follow-Up Period (5th month post-implant) and may have continued for the remainder of the subject's participation in the study.

Participant Flow for 3 periods

Period 1:   Pre-implant Period
    Open Label Group     Treatment Group     Sham Group  
STARTED     45 [1]   10 [1]   15 [1]
COMPLETED     42 [1]   9 [1]   14 [1]
NOT COMPLETED     3     1     1  
Withdrawal by Subject                 2                 0                 0  
Did not meet I/E criteria                 1                 1                 1  
[1] Subjects were not assigned to a group until after initial implant.

Period 2:   Evaluation Period
    Open Label Group     Treatment Group     Sham Group  
STARTED     42     9     14  
COMPLETED     42     9     14  
NOT COMPLETED     0     0     0  

Period 3:   Follow-up Period
    Open Label Group     Treatment Group     Sham Group  
STARTED     42     9     14  
COMPLETED     38     9     12  
NOT COMPLETED     4     0     2  
Withdrawal by Subject                 3                 0                 1  
Lost to Follow-up                 1                 0                 0  
Death                 0                 0                 1  



  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.
Date of birth was not provided for 5 subjects (4 in the Open Label Group and 1 in the Treatment Group), therefore baseline characteristics calculations requiring age/DOB were derived using an N = 60.

Reporting Groups
  Description
Open Label Group Group of subjects who underwent RNS® System implantation who were not randomized or blinded to therapy status during the Evaluation Period. Stimulation may have been enabled during the first month post-implant and may have continued throughout the subject's participation in the study.
Treatment Group Group of subjects who underwent RNS® System implantation who were randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the blinded Evaluation Period. Stimulation was enabled during the first month post-implant and may have continued throughout the subject's participation in the study.
Sham Group Group of subjects who underwent RNS® System implantation who were randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the blinded Evaluation Period. Stimulation may have been enabled after transition into the Follow-Up Period (5th month post-implant) and may have continued for the remainder of the subject's participation in the study.
Total Total of all reporting groups

Baseline Measures
    Open Label Group     Treatment Group     Sham Group     Total  
Number of Participants  
[units: participants]
  42     9     14     65  
Age  
[units: participants]
       
<=18 years     0     1     1     2  
Between 18 and 65 years     38     7     13     58  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  31.2  ± 9.5     27.5  ± 7.6     36.2  ± 12.7     31.9  ± 10.3  
Gender  
[units: participants]
       
Female     21     6     7     34  
Male     21     3     7     31  
Region of Enrollment  
[units: participants]
       
United States     42     9     14     65  
Duration of epilepsy  
[units: years]
Mean ± Standard Deviation
  17.6  ± 10.4     17.4  ± 8.9     17.1  ± 10.3     17.5  ± 10.1  
Number of antiepileptic drugs (AEDs) used over lifetime  
[units: AEDs]
Mean ± Standard Deviation
  8.0  ± 2.6     7.3  ± 2.4     6.6  ± 2.7     7.6  ± 2.6  
Seizure onset location  
[units: participants]
       
Mesial temporal lobe ONLY     8     2     6     16  
Other     34     7     8     49  
Number of seizure foci  
[units: participants]
       
Bifocal     15     5     6     26  
Unifocal     27     4     8     39  
Prior intracranial monitoring for seizure localization  
[units: participants]
       
Prior intracranial monitoring     32     8     13     53  
NO prior intracranial monitoring     10     1     1     12  
Prior therapeutic surgery for epilepsy  
[units: participants]
       
Prior therapeutic surgery for epilepsy     18     2     4     24  
NO prior therapeutic surgery for epilepsy     24     7     10     41  
Prior vagal nerve stimulator (VNS)  
[units: participants]
       
Yes     16     0     2     18  
No     26     9     12     47  
Anatomical brain abnormality (by neuroimaging)  
[units: participants]
       
Yes     18     6     7     31  
No     24     3     7     34  



  Outcome Measures
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1.  Primary:   Acute SAE Rate   [ Time Frame: Initial implant through 1 month post-implant ]

2.  Primary:   Short-term Chronic SAE Rate   [ Time Frame: Initial implant through 3 months post-implant ]

3.  Primary:   Responder Rate   [ Time Frame: Pre-implant baseline through 4 months post-implant ]


  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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dr. Martha Morrell, Chief Medical Officer
Organization: NeuroPace, Inc.
phone: 650-237-2776
e-mail: mmorrell@neuropace.com


Publications of Results:
Barkley GL, Smith B, Bergey G, Worrell G, Chabolla D, Drazkowski J, Labar D, Duckrow R, Murro A, Smith M, Gwinn R, Fisch B, Hirsch L, and Morrell M. Safety and Preliminary Efficacy of the RNS Responsive Neurostimulator for the Treatment of Intractable Epilepsy in Adults. Epilepsia 2006; 47(S4):5.


Responsible Party: NeuroPace
ClinicalTrials.gov Identifier: NCT00079781     History of Changes
Other Study ID Numbers: NP10003
Study First Received: March 12, 2004
Results First Received: November 6, 2013
Last Updated: December 23, 2013
Health Authority: United States: Food and Drug Administration