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NCT05339126

RNS System LGS Feasibility Study

StatusActive, Not Recruiting
PhasePhase 2
SponsorNeuroPace
Primary completion (estimated)

At risk: Primary completion moved at least 6 months later.

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Record History

All 16 versions: 15 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from May 31, 2026 to Nov 30, 2026
    • Eligibility criteria expanded, about 24 words
    • Study description expanded, about 9 words
    • Publications: details revised at 1 of 1 entry
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 6 of 6 sites
    v15
  3. Trial status: Active, Not Recruiting to Recruiting
    • Enrollment target: 22 to 24
    • Primary completion date: Nov 30, 2026 to May 31, 2026
    • Site details revised at 6 of 6 sites
    v14
  4. Primary completion date: May 31, 2026 to Nov 30, 2026v13
  5. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 24 to confirmed 22
    • Site details revised at 6 of 6 sites
    v12
Show 9 earlier versionsHide 9 earlier versions
  1. Primary completion date: Nov 30, 2026 to May 31, 2026
    • Study completion date: May 31, 2027 to Dec 31, 2026
    v11
  2. Site contacts updated at 3 of 6 sitesv10
  3. Primary completion date: Jun 1, 2024 to Nov 30, 2026
    • Enrollment target: 20 to 24
    • Study completion date: Jun 1, 2026 to May 31, 2027
    v9
  4. Site details revised at 4 of 6 sitesv8
  5. Site details revised at 1 of 6 sitesv7
  6. Start date changed from estimate of Oct 1, 2022 to Oct 4, 2022
    • Site details revised at 4 of 6 sites
    v6
  7. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Aug 19, 2022 to Oct 1, 2022
    • Site details revised at 6 of 6 sites
    v5
  8. Start date: Jun 1, 2022 to Aug 19, 2022v4
  9. Study sites: 0 to 6v3
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Safety: Annual device-related serious adverse event (SADE) rate
Timeframe: 12 months post-implant
Effectiveness: Blinded evaluation period (BEP) responder rate
Timeframe: 12 months post-implant

Secondary (1)

Safety: Post-op SAE rate

Arms and interventions

Condition AActive comparator

high-frequency short bursts (HFSB: 100 Hz, 160 µs pulse width, 200 msec burst)

Condition BActive comparator

low-frequency long bursts (LFLB: 5 Hz, 160 µs pulse width, 5 sec burst)

Devices: RNS System

Sites

6 sites in 1 country