Status:
TERMINATED
RNS System RESPONSE Study
Lead Sponsor:
NeuroPace
Conditions:
Epilepsy
Partial Seizure
Eligibility:
All Genders
12-17 years
Phase:
NA
Brief Summary
To demonstrate that the RNS System is safe and effective as an adjunctive therapy in individuals age 12 through 17 years with medically refractory partial onset epilepsy.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Subject has disabling motor simple partial seizures, complex partial seizures, and/or secondarily generalized seizures. Disabling refers to seizures that are severe enough to cause injuries, or significantly impair functional ability in domains including employment, psychosocial education and mobility.
- Subject has seizures that are distinct, stereotypical events that can be reliably counted, in the opinion of the investigator, by the subject or parent/caregiver.
- Subject had an average of three or more disabling motor simple partial seizures, complex partial seizures and/or secondarily generalized seizures over the two most recent consecutive 30-day periods, with no 30-day period with less than two seizures per subject and/or parent/caregiver report.
- Subject failed treatment with a minimum of two anti-seizure medications (used in appropriate doses) with adequate monitoring of compliance and the effects of treatment, as determined by the investigator.
- Subject has undergone diagnostic testing as part of his/her standard care that has identified no more than two epileptogenic regions.
- Subject is male or a female of childbearing potential using a reliable method of contraception (hormonal, barrier method, surgical or abstention).
- Subject is age 12 or older but will be less than age 18 (has not reached 18th birthday) at the time of implantation with the RNS System.
- Subject is able to maintain an electronic diary alone or with the assistance of a competent individual.
- Subject is able to attend clinic appointments in accordance with the study schedule.
- Subject and/or parent/guardian must be willing and able to provide informed consent and assent when appropriate.
- Subject is not currently implanted with an RNS Neurostimulator or NeuroPace Leads.
- In the investigator's opinion, subject is able to tolerate a neurosurgical procedure.
Exclusion
- Subject has been diagnosed with primarily generalized seizures.
- Subject requires procedures that are contraindicated based on current RNS System labeling.
- In the opinion of the investigator, the subject has a clinically significant or unstable medical condition (including alcohol and/or drug abuse) or a progressive central nervous system disease.
- Subject has been diagnosed with active psychosis, major depression or suicidal ideation in the preceding year. Subjects with post-ictal psychiatric symptoms need not be excluded.
- Subject is pregnant.
- Subject is participating in a therapeutic investigational drug or other device study.
- Subject is implanted with an electronic medical device that delivers electrical energy to the brain.
- Subject has been diagnosed with psychogenic or non-epileptic seizures.
- Subject has experienced unprovoked status epilepticus in the preceding year.
- Subject is taking chronic anticoagulants.
- Note: For contraindications, refer to current physician labeling (manuals) for the RNS System available at the NeuroPace website (www.neuropace.com).
Key Trial Info
Start Date :
October 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2025
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04839601
Start Date
October 27 2021
End Date
May 1 2025
Last Update
May 22 2025
Active Locations (2)
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1
Spectrum Health System
Grand Rapids, Michigan, United States, 49503
2
Westchester Medical Center
Hawthorne, New York, United States, 10532