RNS System RESPONSE Study (RESPONSE)
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|ClinicalTrials.gov Identifier: NCT04839601|
Recruitment Status : Not yet recruiting
First Posted : April 9, 2021
Last Update Posted : July 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy Partial Seizure Neurostimulator; Complications Drug Resistant Epilepsy Focal Epilepsy||Device: RNS System||Phase 3|
NeuroPace is sponsoring the RESPONSE Study with the RNS System in individuals age 12 through 17 with partial (focal) onset seizures who have undergone diagnostic testing that localized no more than 2 epileptogenic foci, are refractory to two or more antiepileptic medications, and currently have frequent and disabling seizures. For the purposes of this study, disabling seizures are defined as motor partial seizures, complex partial seizures, and/or secondarily generalized seizures. The RNS System is currently approved by the FDA for use in patients 18 years and older with hard-to-treat partial-onset seizures. The same device will be used in the RESPONSE Study.
The study is a prospective open label single arm pivotal study and participants will be followed for 2 years after placement of the RNS System. The study will enroll a maximum of 200 subjects within the United States to ensure that at least 150 subjects are implanted with the RNS System.
The study design includes one interim analysis which will occur after the 75th implanted patient reaches 12 months post-implant. If the study achieves its primary safety and effectiveness endpoint goals at the interim analysis, the study will be considered successful and enrollment will be stopped.
If the interim analysis does not achieve the primary safety and effectiveness endpoint goals, the study will continue enrolling up to the maximum of 200 patients. A final analysis will be conducted after the 150th implanted patient reaches 12 months post-implant.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||RNS® System Responsive Stimulation for Adolescents With Epilepsy Study|
|Estimated Study Start Date :||August 1, 2021|
|Estimated Primary Completion Date :||July 1, 2026|
|Estimated Study Completion Date :||December 31, 2027|
Experimental: Evaluation Group (stimulation ON)
Group of participants that have an RNS System implanted and are being treated with responsive stimulation.
Device: RNS System
The RNS System provides closed loop responsive brain stimulation. The Neurostimulator monitors the electrical activity of the brain to detect abnormal activity that could lead to a seizure. If abnormal activity is detected, the neurostimulator delivers electrical stimulation to the brain through the leads to help prevent the seizure before it occurs.
- Short-term chronic serious adverse device effect (SADE) rate [ Time Frame: 84-days post-implant ]The primary safety endpoint is the percent of subjects with serious device-related adverse events at 84 days (12 weeks) post-implant.
- Responder rate at 12 months post implant [ Time Frame: The primary effectiveness endpoint is the percent of subjects with a ≥ 50% reduction in seizures at 12 months post-implant compared to the pre-implant baseline. ]12 months post-implant
- Device-related Serious Adverse Event (SADE) event rate [ Time Frame: Implant through 2 years post-implant ]The annual SADE event rate over time in subjects age 12 - 17 years implanted with the neurostimulator and/or leads during study participation will be calculated
- Event rate of Serious Adverse Events (SAEs) of particular relevance [ Time Frame: Implant through 2 years post-implant ]
The annual event rate of SAEs of particular relevance (device-related or not) will be calculated over time in subjects age 12 - 17 years implanted with the neurostimulator and/or leads during study participation.
SAEs of particular relevance include those related to:
- intracranial hemorrhage
- new more disabling seizure types
- Affective status as measured by the Beck Depression Inventory [ Time Frame: Implant through 2 years post-implant ]Affective status (by summary scores from the Beck Depression Inventory (BDI), either the BDI-II or Beck Youth Inventory (BYI-II), depending on age at time of the initial clinic appointment) will be described pre-implant, as well as for the post-implant months 3, 6, 9, 12 and then every four months.
- Neuropsychological functioning as assessed by a sub-set of tests in the NIH Toolbox Cognition Battery [ Time Frame: Implant through 2 years post-implant ]Neuropsychological functioning as assessed by neuropsychological testing with pediatric validated, standardized inventories to assess 3 domains that include attention, memory, and vocabulary (Flanker Inhibitory Control and Attention Test, Picture Sequence Memory Test, and Picture Vocabulary Test, respectively). These inventories are taken from the NIH Toolbox Cognition Battery and will be described by presenting summary scores for the pre-neurostimulator implant period, as well as for the annual appointments.
- Percentage change in seizure frequency [ Time Frame: Implant through 2 years post-implant ]The percentage change in seizure frequency will be summarized and reported by medians and responder rates for each 3-month interval beginning 4 months post-implant.
- Quality of life as assessed by the Quality of Life in Epilepsy Inventory (QOLIE) [ Time Frame: Implant through 2 years post-implant ]Quality of life [by summary scores from the QOLIE-AD-48 (validated for ages 12 - 17 years) or QOLIE-31-P (validated for ages 18 and older), depending on age at time of assessment] will be described pre-neurostimulator implant, as well as at yearly time points.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04839601
|Contact: Kerry Flynnemail@example.com|
|Contact: Tracy Courtneyfirstname.lastname@example.org|
|Principal Investigator:||Martha Morrell, MD||NeuroPace, Inc.|