RNS® System LTT Study
Açar sözlər
Mücərrəd
Təsvir
NeuroPace, Inc. is sponsoring an investigational device study of the RNS® System, the first closed loop responsive brain stimulator designed to treat refractory epilepsy. The RNS® System LTT study is an open-label multi-center prospective 7-year clinical investigation which follows completion of the RNS® System Pivotal or Feasibility study. Data regarding safety and efficacy are collected at 6-month intervals, and data regarding quality of life are collected at yearly intervals.
The study is designed to assess the ongoing safety and to evaluate the long-term efficacy of the RNS® System as an adjunctive therapy in reducing the frequency of medically uncontrolled and disabling partial onset seizures that start from one or two areas of the brain.
The RNS® System LTT study will provide additional data on the safety and efficacy of the RNS® System for 7 years following a subject's completion of the RNS® System Feasibility or Pivotal studies. Data from the RNS® System LTT study will be combined with data collected during the RNS® System Feasibility and Pivotal studies, resulting in 9 total years of post-implant follow-up data. These data will be used to calculate long-term SAE rate, percent change in seizure frequency (from pre-implant baseline), as well as the frequency of sudden unexplained death in epilepsy (SUDEP).
The RNS® Neurostimulator (a pacemaker-like device) and NeuroPace® Leads (tiny wires with electrodes) are implanted in the head. The Neurostimulator is a battery powered, microprocessor controlled device that detects and stores records of electrographic patterns (such as epileptiform, or seizure-like, activity) from the Leads within the brain. When the device detects an electrographic pattern, it responds by sending electrical stimulation through the Leads to a small part of the patient's brain to interrupt the electrographic pattern. This type of treatment is called responsive stimulation, but it is not yet known if it will work for the treatment of epilepsy. Direct brain stimulation therapy has already received approval in the United States, Europe, Canada, and Australia for the treatment of Essential Tremor and Parkinson's disease. Direct brain stimulation is not approved for the treatment of epilepsy.
Tarixlər
| Son Doğrulandı: | 04/30/2019 |
| İlk təqdim: | 12/09/2007 |
| Təxmini qeydiyyat təqdim edildi: | 12/09/2007 |
| İlk Göndərmə: | 12/11/2007 |
| Son Yeniləmə Göndərildi: | 05/30/2019 |
| Son Yeniləmə Göndərildi: | 06/25/2019 |
| İlk təqdim edilmiş nəticələrin tarixi: | 04/24/2019 |
| İlk təqdim edilmiş QC nəticələrinin tarixi: | 05/30/2019 |
| İlk göndərilən nəticələrin tarixi: | 06/25/2019 |
| Həqiqi Təhsilin Başlama Tarixi: | 03/31/2006 |
| Təxmini İlkin Tamamlanma Tarixi: | 04/30/2018 |
| Təxmini İşin Tamamlanma Tarixi: | 04/30/2018 |
Vəziyyət və ya xəstəlik
Müdaxilə / müalicə
Device: Evaluation Group (stimulation ON)
Faza
Qol Qrupları
| Qol | Müdaxilə / müalicə |
|---|---|
| Experimental: Evaluation Group (stimulation ON) Group of subjects that have an RNS® System implanted, completed the RNS® System Pivotal or Feasibility study, and elected to continue to receive RNS® System responsive stimulation for the long term. | Device: Evaluation Group (stimulation ON) The previously implanted RNS® System is programmed to provide responsive stimulation. Upon detecting electrographic patterns, previously identified by the neurologist or neurosurgeon as abnormal, the Neurostimulator provides brief pulses of electrical stimulation through the Leads to interrupt those patterns. Patients with epilepsy treated with responsive direct-brain stimulation with the RNS System typically receive less than 6 minutes of stimulation a day. |
Uyğunluq Kriteriyaları
| Təhsil üçün uyğun yaşlar | 18 Years Üçün 18 Years |
| Təhsilə Uyğun Cinslər | All |
| Sağlam Könüllüləri qəbul edir | Bəli |
| Kriteriyalar | Inclusion Criteria: 1. Subject has completed either the RNS® System Pivotal or Feasibility study 2. Subject has an implanted RNS® System 3. Subject has elected to continue to receive responsive neurostimulation therapy after completion of the RNS® System Pivotal or Feasibility study 4. Subject is able to attend scheduled appointments for the RNS® System LTT study Exclusion Criteria: 1. Subject has active psychiatric or medical illness that makes it inadvisable for the subject to continue to receive responsive neurostimulation therapy with the RNS® System 2. Subject has been diagnosed with psychogenic or non-epileptic seizures, or primarily generalized seizures during the RNS® System Pivotal or Feasibility study 3. Subject has been noncompliant with scheduled appointments during the RNS® System Pivotal or Feasibility study 4. Subject has been noncompliant with maintaining seizure diaries during the RNS® System Pivotal or Feasibility study 5. Informed consent cannot be obtained from subject or caregiver |
Nəticə
İlkin nəticə tədbirləri
1. Number of Participants With Serious Adverse Events (SAE) [2 years post-implant through 9 years post-implant (7 years)]
2. Percentage Change From Baseline in Seizure Frequency [6 months post-implant through 9 years post-implant (8.5 years)]
İkincili Nəticə Tədbirləri
1. Responder Rate [6 months post-implant through 9 years post-implant (8.5 years)]
2. QOLIE (Quality of Life in Epilepsy) [1 year post-implant through 9 years post-implant (8 years)]
3. Adverse Event Rate [6 months post-implant through 9 years post-implant (8.5 years)]
