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BTSEENCT06424977

Biomarker Targeted Stimulation for Epileptiform Events

StatusNot Yet Recruiting
PhaseNot applicable
Primary completion (estimated)
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Record History

All 4 versions: 4 with changes below. See every version on ClinicalTrials.gov ↗

  1. Start date: Sep 1, 2026 to Nov 1, 2026 Show 5 more changesShow less
    • Primary completion moved earlier from Sep 1, 2028 to May 1, 2028
    • Study completion pushed from Feb 14, 2030 to Nov 1, 2030
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 1 of 8 entries
    • Publications: details revised at 5 of 5 entries
  2. Primary completion date: Dec 1, 2027 to Sep 1, 2028
    • Start date: Sep 1, 2025 to Sep 1, 2026
    • Study completion date: Sep 1, 2029 to Feb 14, 2030
    v3
  3. Primary completion date: Dec 1, 2026 to Dec 1, 2027
    • Start date: Sep 1, 2024 to Sep 1, 2025
    • Study completion date: Sep 1, 2028 to Sep 1, 2029
    v2
  4. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Adverse event rate
Timeframe: Intervals through 7, 12, and 24 months post-implant

Secondary (8)

Seizure frequency
Neurocognitive testing
Depression testing
Anxiety testing
Quality of life testing
Show 3 moreShow less
Sleep testing
Seizure severity testing
Caregiver burden testing

Arms and interventions

TreatmentExperimental

Devices: Biomarker Targeted Stimulation (BTS)