Active Group (responsive stimulation ON) for Idiopathic Generalized Epilepsy

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Idiopathic Generalized Epilepsy+2 MoreResponsive stimulation - Device
Eligibility
Any Age
All Sexes
What conditions do you have?
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Study Summary

This trial shows that the RNS System for thalamic stimulation is safe and effective for reducing primary generalized seizures in individuals 12 years of age or older with drug-resistant idiopathic generalized epilepsy.

Eligible Conditions
  • Idiopathic Generalized Epilepsy
  • Grand Mal Seizure
  • Epilepsy

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: Implant through 2 years post-implant

Week 12
12-week post-operative serious device-related adverse event (SADE) rate
9-month Effectiveness Evaluation Period
Amenorrhea
Time to second generalized tonic-clonic (GTC) seizure
Month 3
Percent change in seizure frequency
Year 2
Annual event rate of Serious Adverse Device Effects (SADEs)
Annual event rate of Serious Adverse Events (SAEs) of particular relevance
Year 2
Affective status as assessed by the Beck Depression Inventory
Health affecting behaviors assessment
Neuropsychological functioning as assessed by a sub-set of tests in the NIH Toolbox Cognition Battery
Quality of life as assessed by the Quality of Life in Epilepsy Inventory
Sleep assessment as assessed by sleep habit questionnaires

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Active Group (responsive stimulation ON)
1 of 2
Sham Group (responsive stimulation OFF)
1 of 2

Active Control

Non-Treatment Group

100 Total Participants · 2 Treatment Groups

Primary Treatment: Active Group (responsive stimulation ON) · Has Placebo Group · Phase 3

Active Group (responsive stimulation ON)
Device
ActiveComparator Group · 1 Intervention: Responsive stimulation · Intervention Types: Device
Sham Group (responsive stimulation OFF)
Device
ShamComparator Group · 1 Intervention: Sham stimulation · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: implant through 2 years post-implant

Who is running the clinical trial?

NeuroPaceLead Sponsor
10 Previous Clinical Trials
1,395 Total Patients Enrolled
Martha Morrell, MDPrincipal InvestigatorNeuroPace, Inc.
2 Previous Clinical Trials
220 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

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