CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 230 enrolled
Drug / intervention
RNS® Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00572195
NCT00572195Phase 4Completed
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RNS® System Long-term Treatment (LTT) Clinical Investigation

NeuroPace·interventional·Posted Dec 12, 2007·Updated Jun 26, 2019

In Brief

A Phase 4 clinical trial evaluating RNS® System for Epilepsy. Completed, enrolled 230 participants across 33 sites.

Detailed Summary

The RNS® System LTT 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 seizures in individuals 18 years of age or older with partial onset seizures that are refractory to two or more antiepileptic medications. Candidates will continue to receive their epilepsy medications while participating in the trial.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 12, 2007
Enrollment StartApr 1, 2006
Primary CompletionMay 1, 2018
TodayJul 2, 2026
Enrollment to primary: 12.1 yearsPosted 18.6 years ago

Interventions

RNS® Systemdevice

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.