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RNS® System Feasibility Study

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ClinicalTrials.gov Identifier: NCT00079781
Recruitment Status : Completed
First Posted : March 16, 2004
Results First Posted : December 24, 2013
Last Update Posted : January 29, 2014
Sponsor:
Information provided by (Responsible Party):
NeuroPace

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Epilepsy
Interventions Procedure: RNS® System implantation
Device: RNS® System responsive stimulation
Enrollment 70
Recruitment Details 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 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.
Arm/Group Title Open Label Group Treatment Group Sham Group
Hide Arm/Group Description 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. 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. 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.
Period Title: Pre-implant Period
Started 45 [1] 10 [1] 15 [1]
Completed 42 [1] 9 [1] 14 [1]
Not Completed 3 1 1
Reason Not Completed
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 Title: Evaluation Period
Started 42 9 14
Completed 42 9 14
Not Completed 0 0 0
Period Title: Follow-up Period
Started 42 9 14
Completed 38 9 12
Not Completed 4 0 2
Reason Not Completed
Withdrawal by Subject             3             0             1
Lost to Follow-up             1             0             0
Death             0             0             1
Arm/Group Title Open Label Group Treatment Group Sham Group Total
Hide Arm/Group Description 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 42 9 14 65
Hide Baseline Analysis Population Description
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.
Age, Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants 9 participants 14 participants 65 participants
<=18 years 0 1 1 2
Between 18 and 65 years 38 7 13 58
>=65 years 0 0 0 0
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 9 participants 14 participants 65 participants
31.2  (9.5) 27.5  (7.6) 36.2  (12.7) 31.9  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 9 participants 14 participants 65 participants
Female
21
  50.0%
6
  66.7%
7
  50.0%
34
  52.3%
Male
21
  50.0%
3
  33.3%
7
  50.0%
31
  47.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 42 participants 9 participants 14 participants 65 participants
42 9 14 65
Duration of epilepsy  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 9 participants 14 participants 65 participants
17.6  (10.4) 17.4  (8.9) 17.1  (10.3) 17.5  (10.1)
Number of antiepileptic drugs (AEDs) used over lifetime  
Mean (Standard Deviation)
Unit of measure:  AEDs
Number Analyzed 42 participants 9 participants 14 participants 65 participants
8.0  (2.6) 7.3  (2.4) 6.6  (2.7) 7.6  (2.6)
Seizure onset location  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants 9 participants 14 participants 65 participants
Mesial temporal lobe ONLY 8 2 6 16
Other 34 7 8 49
Number of seizure foci  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants 9 participants 14 participants 65 participants
Bifocal 15 5 6 26
Unifocal 27 4 8 39
Prior intracranial monitoring for seizure localization  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants 9 participants 14 participants 65 participants
Prior intracranial monitoring 32 8 13 53
NO prior intracranial monitoring 10 1 1 12
Prior therapeutic surgery for epilepsy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants 9 participants 14 participants 65 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)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants 9 participants 14 participants 65 participants
Yes 16 0 2 18
No 26 9 12 47
Anatomical brain abnormality (by neuroimaging)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants 9 participants 14 participants 65 participants
Yes 18 6 7 31
No 24 3 7 34
1.Primary Outcome
Title Acute SAE Rate
Hide Description

RNS® System Acute SAE Rate = the percentage of subjects having a serious adverse event (SAE) for the surgical implant procedure and the following month (28 days), whether reported as device-related or not.

This outcome measure is met when the upper limit of the one-sided 95% confidence interval of the observed RNS® System Acute SAE Rate does not exceed the upper limit of the one-sided 95% confidence interval of the literature-based acute SAE rate associated with the implantation of intracranial electrodes for localization procedures and epilepsy surgery combined as documented in the literature (rate = 19%; upper CI = 28%). The comparator was calculated based upon the literature, therefore the number of participants analyzed is unknown/not applicable.

The primary safety outcome measure was met.

Time Frame Initial implant through 1 month post-implant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Participants
Hide Arm/Group Description:
Open Label Group, Treatment Group, and Sham Group combined.
Overall Number of Participants Analyzed 65
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
6.2
(2.4 to 14.8)
2.Primary Outcome
Title Short-term Chronic SAE Rate
Hide Description

The RNS® System Short-term Chronic SAE rate = the percentage of implanted subjects having a serious adverse event (SAE) for the surgical implant procedure and the following 3 months (84 days), whether reported as device-related or not.

This outcome measure is met when the upper limit of the one-sided 95% confidence interval of the observed RNS® System Short-term Chronic SAE Rate does not exceed the upper limit of the one-sided 95% confidence interval of the historical short-term chronic SAE rate for deep brain stimulation for movement disorders from the published literature (rate = 36%; upper CI = 46%). The comparator was calculated based upon the literature, therefore the number of participants analyzed is unknown/not applicable.

The primary safety outcome measure was met.

Time Frame Initial implant through 3 months post-implant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Participants
Hide Arm/Group Description:
Open Label Group, Treatment Group, and Sham Group combined.
Overall Number of Participants Analyzed 65
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
9.2
(4.3 to 18.7)
3.Primary Outcome
Title Responder Rate
Hide Description

Percentage of subjects with a 50% or greater reduction in mean seizure frequency during the post-implant Evaluation Period (4 months or 112 days) compared to pre-implant baseline (collected during the Prospective Seizure Frequency study). The primary effectiveness endpoint would be met with an observed responder rate of 13% or more.

The effectiveness endpoint was only calculated for the Treatment Population. The endpoint was used to support a Pivotal Study, not to demonstrate efficacy when compared to a control/sham group.

The primary effectiveness endpoint was met.

Time Frame Pre-implant baseline through 4 months post-implant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Population
Hide Arm/Group Description:
Open Label Group and Treatment Group combined.
Overall Number of Participants Analyzed 51
Measure Type: Number
Unit of Measure: Percent of participants
24
Time Frame Initial implant through 2 years post-implant
Adverse Event Reporting Description

SAE = a positive or negative change in subject‘s physical/mental health as experienced by subject or observed by physician, during any part of the study, that resulted in:

  • significant risks/consequences to patient’s acute or long-term health
  • serious injury or death
  • hospitalization or invasive medical intervention required to alleviate event
 
Arm/Group Title Treatment Population Sham Group
Hide Arm/Group Description Open Label Group and Treatment Group combined. 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.
All-Cause Mortality
Treatment Population Sham Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Population Sham Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/51 (43.14%)      7/14 (50.00%)    
Gastrointestinal disorders     
Vomiting * 1  1/51 (1.96%)  1 0/14 (0.00%)  0
General disorders     
Death * 1  0/51 (0.00%)  0 1/14 (7.14%)  1
Infections and infestations     
Appendicitis * 1  1/51 (1.96%)  1 0/14 (0.00%)  0
Cystitis * 1  1/51 (1.96%)  1 0/14 (0.00%)  0
Upper respiratory tract infection * 1  1/51 (1.96%)  1 0/14 (0.00%)  0
Injury, poisoning and procedural complications     
Contusion (due to seizure) * 1  1/51 (1.96%)  1 0/14 (0.00%)  0
Device lead damage * 1  0/51 (0.00%)  0 1/14 (7.14%)  1
Implant site erosion * 1  1/51 (1.96%)  1 0/14 (0.00%)  0
Joint injury (due to seizure) * 1  1/51 (1.96%)  1 0/14 (0.00%)  0
Lower limb fracture * 1  0/51 (0.00%)  0 1/14 (7.14%)  1
Premature battery depletion * 1  6/51 (11.76%)  6 2/14 (14.29%)  2
Skin laceration (due to seizure) * 1  1/51 (1.96%)  1 0/14 (0.00%)  0
Therapeutic agent toxicity * 1  1/51 (1.96%)  1 1/14 (7.14%)  1
Investigations     
Biopsy lung * 1  0/51 (0.00%)  0 1/14 (7.14%)  1
EEG monitoring * 1  2/51 (3.92%)  2 0/14 (0.00%)  0
Psychiatric evaluation * 1  1/51 (1.96%)  1 0/14 (0.00%)  0
Metabolism and nutrition disorders     
Hyperammonaemia * 1  0/51 (0.00%)  0 1/14 (7.14%)  1
Musculoskeletal and connective tissue disorders     
Back pain * 1  1/51 (1.96%)  1 0/14 (0.00%)  0
Osteonecrosis * 1  1/51 (1.96%)  1 0/14 (0.00%)  0
Nervous system disorders     
Coma * 1  0/51 (0.00%)  0 1/14 (7.14%)  1
Complex partial seizures increased * 1  3/51 (5.88%)  3 0/14 (0.00%)  0
Confusional state * 1  1/51 (1.96%)  1 0/14 (0.00%)  0
Headache * 1  1/51 (1.96%)  1 0/14 (0.00%)  0
Nonconvulsive status epilepticus * 1  1/51 (1.96%)  1 1/14 (7.14%)  1
Postictal paralysis * 1  0/51 (0.00%)  0 1/14 (7.14%)  1
Simple partial seizures increased (motor) * 1  1/51 (1.96%)  5 2/14 (14.29%)  3
Tonic-clonic seizures * 1  1/51 (1.96%)  1 0/14 (0.00%)  0
Tonic-clonic seizures exacerbated * 1  1/51 (1.96%)  1 0/14 (0.00%)  0
Tonic-clonic seizures increased * 1  1/51 (1.96%)  1 2/14 (14.29%)  2
Pregnancy, puerperium and perinatal conditions     
Live birth * 1  1/51 (1.96%)  1 0/14 (0.00%)  0
Psychiatric disorders     
Depression * 1  1/51 (1.96%)  1 0/14 (0.00%)  0
Suicide attempt * 1  1/51 (1.96%)  2 0/14 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pneumonia aspiration * 1  0/51 (0.00%)  0 1/14 (7.14%)  1
Surgical and medical procedures     
Medical device removal * 1  3/51 (5.88%)  3 1/14 (7.14%)  1
Vascular disorders     
Deep vein thrombosis * 1  1/51 (1.96%)  1 0/14 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Ver 10.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2.5%
Treatment Population Sham Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   48/51 (94.12%)      14/14 (100.00%)    
Eye disorders     
Diplopia * 1  5/51 (9.80%)  5 0/14 (0.00%)  0
Eye pain * 1  2/51 (3.92%)  2 1/14 (7.14%)  1
Vision blurred * 1  4/51 (7.84%)  5 1/14 (7.14%)  1
Visual acuity reduced * 1  0/51 (0.00%)  0 2/14 (14.29%)  2
Visual disturbance * 1  0/51 (0.00%)  0 2/14 (14.29%)  2
Gastrointestinal disorders     
Diarrhoea * 1  4/51 (7.84%)  6 1/14 (7.14%)  2
Gastroenteritis * 1  3/51 (5.88%)  3 0/14 (0.00%)  0
Nausea * 1  3/51 (5.88%)  3 1/14 (7.14%)  1
Toothache * 1  1/51 (1.96%)  1 1/14 (7.14%)  1
Vomiting * 1  3/51 (5.88%)  5 1/14 (7.14%)  2
General disorders     
Adverse drug reaction * 1  6/51 (11.76%)  7 0/14 (0.00%)  0
Device interaction * 1  6/51 (11.76%)  6 0/14 (0.00%)  0
Fatigue * 1  4/51 (7.84%)  4 3/14 (21.43%)  4
Gait disturbance * 1  0/51 (0.00%)  0 2/14 (14.29%)  2
Implant site discharge * 1  3/51 (5.88%)  4 0/14 (0.00%)  0
Implant site pain * 1  10/51 (19.61%)  11 5/14 (35.71%)  5
Implant site paraesthesia * 1  4/51 (7.84%)  4 1/14 (7.14%)  1
Night sweats * 1  2/51 (3.92%)  2 0/14 (0.00%)  0
Oedema peripheral * 1  1/51 (1.96%)  1 1/14 (7.14%)  2
Pyrexia * 1  2/51 (3.92%)  3 0/14 (0.00%)  0
Immune system disorders     
Drug hypersensitivity * 1  3/51 (5.88%)  4 1/14 (7.14%)  1
Seasonal allergy * 1  6/51 (11.76%)  8 0/14 (0.00%)  0
Infections and infestations     
Ear infection * 1  2/51 (3.92%)  2 1/14 (7.14%)  1
Influenza * 1  5/51 (9.80%)  9 3/14 (21.43%)  7
Nasopharyngitis * 1  15/51 (29.41%)  21 3/14 (21.43%)  6
Pneumonia * 1  2/51 (3.92%)  2 2/14 (14.29%)  2
Respiratory tract infection * 1  2/51 (3.92%)  2 0/14 (0.00%)  0
Sinusitis * 1  2/51 (3.92%)  2 0/14 (0.00%)  0
Tooth infection * 1  2/51 (3.92%)  4 1/14 (7.14%)  1
Upper respiratory tract infection * 1  7/51 (13.73%)  10 1/14 (7.14%)  2
Urinary tract infection * 1  1/51 (1.96%)  1 1/14 (7.14%)  1
Injury, poisoning and procedural complications     
Back injury (due to seizure) * 1  3/51 (5.88%)  3 0/14 (0.00%)  0
Concussion (due to seizure) * 1  2/51 (3.92%)  3 0/14 (0.00%)  0
Contusion * 1  3/51 (5.88%)  4 1/14 (7.14%)  1
Contusion (due to seizure) * 1  3/51 (5.88%)  4 1/14 (7.14%)  1
Fall * 1  2/51 (3.92%)  2 0/14 (0.00%)  0
Hand fracture (due to seizure) * 1  2/51 (3.92%)  2 0/14 (0.00%)  0
Head injury (due to seizure) * 1  4/51 (7.84%)  4 0/14 (0.00%)  0
Implant site swelling * 1  6/51 (11.76%)  6 1/14 (7.14%)  1
Joint injury * 1  2/51 (3.92%)  2 0/14 (0.00%)  0
Joint injury (due to seizure) * 1  3/51 (5.88%)  3 0/14 (0.00%)  0
Multiple injuries (due to seizure) * 1  2/51 (3.92%)  2 0/14 (0.00%)  0
Postoperative fever * 1  3/51 (5.88%)  3 1/14 (7.14%)  1
Procedural dizziness * 1  2/51 (3.92%)  2 0/14 (0.00%)  0
Procedural headache * 1  24/51 (47.06%)  24 8/14 (57.14%)  8
Procedural nausea * 1  4/51 (7.84%)  4 1/14 (7.14%)  1
Procedural vomiting * 1  4/51 (7.84%)  4 2/14 (14.29%)  2
Road traffic accident * 1  1/51 (1.96%)  1 1/14 (7.14%)  1
Skin laceration * 1  3/51 (5.88%)  4 1/14 (7.14%)  1
Skin laceration (due to seizure) * 1  2/51 (3.92%)  9 1/14 (7.14%)  1
Therapeutic agent toxicity * 1  12/51 (23.53%)  17 7/14 (50.00%)  9
Investigations     
Weight increased * 1  1/51 (1.96%)  1 1/14 (7.14%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  2/51 (3.92%)  2 0/14 (0.00%)  0
Back pain * 1  8/51 (15.69%)  8 2/14 (14.29%)  2
Muscle twitching * 1  5/51 (9.80%)  5 0/14 (0.00%)  0
Musculoskeletal pain * 1  3/51 (5.88%)  3 1/14 (7.14%)  1
Musculoskeletal stiffness * 1  2/51 (3.92%)  2 0/14 (0.00%)  0
Neck pain * 1  1/51 (1.96%)  1 1/14 (7.14%)  1
Pain in extremity * 1  2/51 (3.92%)  2 0/14 (0.00%)  0
Pain in jaw * 1  2/51 (3.92%)  2 1/14 (7.14%)  1
Nervous system disorders     
Aphasia * 1  1/51 (1.96%)  1 1/14 (7.14%)  1
Ataxia * 1  1/51 (1.96%)  1 2/14 (14.29%)  2
Balance disorder * 1  2/51 (3.92%)  2 0/14 (0.00%)  0
Bradyphrenia * 1  3/51 (5.88%)  3 0/14 (0.00%)  0
Complex partial seizures * 1  3/51 (5.88%)  5 2/14 (14.29%)  2
Complex partial seizures exacerbated * 1  1/51 (1.96%)  1 1/14 (7.14%)  1
Complex partial seizures increased * 1  13/51 (25.49%)  19 6/14 (42.86%)  6
Confusional state * 1  3/51 (5.88%)  4 0/14 (0.00%)  0
Dizziness * 1  7/51 (13.73%)  8 1/14 (7.14%)  2
Dysaesthesia * 1  7/51 (13.73%)  7 1/14 (7.14%)  1
Dysarthria * 1  3/51 (5.88%)  3 0/14 (0.00%)  0
Eyelid ptosis * 1  1/51 (1.96%)  1 1/14 (7.14%)  1
Headache * 1  14/51 (27.45%)  22 5/14 (35.71%)  9
Hypoaesthesia * 1  5/51 (9.80%)  5 1/14 (7.14%)  1
Insomnia * 1  5/51 (9.80%)  6 4/14 (28.57%)  5
Memory impairment * 1  5/51 (9.80%)  5 3/14 (21.43%)  5
Migraine * 1  2/51 (3.92%)  2 1/14 (7.14%)  1
Nystagmus * 1  3/51 (5.88%)  3 1/14 (7.14%)  1
Paraesthesia * 1  3/51 (5.88%)  4 1/14 (7.14%)  1
Photophobia * 1  1/51 (1.96%)  1 1/14 (7.14%)  1
Photopsia * 1  2/51 (3.92%)  2 2/14 (14.29%)  2
Post-traumatic headache * 1  2/51 (3.92%)  2 0/14 (0.00%)  0
Postictal headache * 1  0/51 (0.00%)  0 2/14 (14.29%)  2
Simple partial seizures (motor) * 1  5/51 (9.80%)  7 1/14 (7.14%)  4
Simple partial seizures (sensory) * 1  3/51 (5.88%)  3 1/14 (7.14%)  1
Simple partial seizures increased (motor) * 1  1/51 (1.96%)  1 2/14 (14.29%)  3
Simple partial seizures increased (sensory) * 1  2/51 (3.92%)  3 0/14 (0.00%)  0
Somnolence * 1  4/51 (7.84%)  4 1/14 (7.14%)  2
Tonic-clonic seizures * 1  1/51 (1.96%)  1 2/14 (14.29%)  2
Tonic-clonic seizures exacerbated * 1  3/51 (5.88%)  4 0/14 (0.00%)  0
Tonic-clonic seizures increased * 1  3/51 (5.88%)  3 4/14 (28.57%)  4
Tremor * 1  8/51 (15.69%)  9 0/14 (0.00%)  0
Psychiatric disorders     
Affect lability * 1  2/51 (3.92%)  4 1/14 (7.14%)  1
Agitation * 1  3/51 (5.88%)  3 1/14 (7.14%)  1
Anxiety * 1  2/51 (3.92%)  2 0/14 (0.00%)  0
Depression * 1  8/51 (15.69%)  9 2/14 (14.29%)  2
Depression suicidal * 1  1/51 (1.96%)  1 2/14 (14.29%)  2
Libido decreased * 1  5/51 (9.80%)  5 0/14 (0.00%)  0
Renal and urinary disorders     
Dysuria * 1  1/51 (1.96%)  1 1/14 (7.14%)  1
Respiratory, thoracic and mediastinal disorders     
Bronchitis * 1  1/51 (1.96%)  1 1/14 (7.14%)  1
Dyspnoea * 1  1/51 (1.96%)  1 1/14 (7.14%)  1
Nasal congestion * 1  1/51 (1.96%)  1 1/14 (7.14%)  1
Pharyngolaryngeal pain * 1  4/51 (7.84%)  5 1/14 (7.14%)  1
Skin and subcutaneous tissue disorders     
Acne * 1  0/51 (0.00%)  0 2/14 (14.29%)  2
Ingrown hair * 1  2/51 (3.92%)  2 0/14 (0.00%)  0
Pain of skin * 1  1/51 (1.96%)  1 1/14 (7.14%)  1
Pruritus * 1  2/51 (3.92%)  3 0/14 (0.00%)  0
Rash * 1  7/51 (13.73%)  7 0/14 (0.00%)  0
Swelling face * 1  4/51 (7.84%)  4 0/14 (0.00%)  0
Surgical and medical procedures     
Endodontic procedure * 1  1/51 (1.96%)  1 1/14 (7.14%)  1
Vascular disorders     
Hypertension * 1  3/51 (5.88%)  3 0/14 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Ver 10.1
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.
Each Investigator, Coordinator, and Institution agree to submit publications to the RNS® System Study Publication Committee for review prior to submission for publication (at least 30 days for manuscripts and at least 7 days for abstracts) to assure that publication does not compromise the scientific integrity of the study or contain confidential NeuroPace information. NeuroPace may require that presentation/publication be withheld for up to 60 days to allow for filing of a patent application.
Results Point of Contact
Name/Title: Dr. Martha Morrell, Chief Medical Officer
Organization: NeuroPace, Inc.
Phone: 650-237-2776
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
First Submitted: March 12, 2004
First Posted: March 16, 2004
Results First Submitted: November 6, 2013
Results First Posted: December 24, 2013
Last Update Posted: January 29, 2014