RNS System NAUTILUS Study (NCT05147571) | Clinical Trial Compass
Active ā Not RecruitingPhase 3
RNS System NAUTILUS Study
United States100 participantsStarted 2022-08-09
Plain-language summary
To demonstrate that the RNS System for thalamic stimulation is safe and effective as an adjunctive therapy for the reduction of primary generalized seizures in individuals 12 years of age or older who have drug-resistant idiopathic generalized epilepsy.
Who can participate
Age range12 Years
SexALL
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Inclusion Criteria:
* Participant is age 12 and older.
* Participant is male or is a female of childbearing potential who is surgically sterile, 2 years postmenopausal, or practices a reliable method of contraception (hormonal, barrier method or abstention).
* Participant failed treatment with a minimum of two antiseizure medications (used in appropriate doses) with adequate monitoring of compliance and the effects of treatment, as determined by the investigator.
* Participant is able to maintain an electronic diary alone or with the assistance of a competent individual.
* Participant is able to attend clinic appointments in accordance with the study schedule.
* Participant or parent(s) or legal representative have signed an IRB approved written informed consent/assent. The informed consent form or specific assent form, where required, will be signed and dated by minors.
* Participant is not currently implanted with an RNS Neurostimulator or NeuroPace Leads.
* In the investigator's opinion, participant is able to tolerate a neurosurgical procedure.
* Participant with a confirmed diagnosis of idiopathic generalized epilepsy experiencing primary generalized tonic-clonic seizures, with or without myoclonic or absence seizures, consistent with the International League against Epilepsy Revised Classification of Seizures (2017).
* Participant has had 2 or more generalized tonic-clonic seizures during the two month retrospective baseline.
* Participant has had a routine electroenceā¦