Acute Recording of Stereotyped High-Frequency Oscillations

StatusActive, Not Recruiting
PhaseNot applicable
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint added 2 → 3 primary endpoints
See other at-risk trials from Mayo Clinic

Record History

See every version on ClinicalTrials.gov ↗

  1. Results posted: Oct 15, 2026 Show 5 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment increased: 12 → 17 participants
    • Study completion pushed from Aug 11, 2026 to Oct 31, 2026
    • Publications: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 5 words
  2. Primary completion moved earlier from Aug 28, 2026 to Aug 11, 2025
    • Study completion moved earlier from Mar 31, 2027 to Aug 11, 2026
    v8
  3. Primary completion date: Aug 4, 2025 to Aug 28, 2026
    • Trial status: Completed to Active, Not Recruiting
    • Study completion date: Aug 4, 2025 to Mar 31, 2027
    v7
  4. Trial status: Recruiting to Completed
    • Primary completion date changed from estimate of Jul 1, 2026 to Aug 4, 2025
    • Study completion date changed from estimate of Aug 31, 2026 to Aug 4, 2025
    • Site details revised at 2 of 2 sites
    v6
  5. Enrollment target: 20 to 12
    • Primary endpoints: 3 to 2
    • Site contacts updated at 1 of 2 sites
    • Study title revised
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites revised (2)v4
  2. Phase: Early Phase 1 to Not applicable
    • Lead sponsor: University of Houston to Mayo Clinic
    v3
  3. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised at 2 of 2 sites
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Mayo Clinic
1,027 trials monitored
See 130 trials at risk
Epilepsy
783 trials monitored
See 48 trials at risk
Overall, this study will investigate the functional utility of stereotyped HFOs by capturing them with a new implantable system (Brain Interchange - BIC of CorTec), which can sample neural data at higher rates \>=1kHz and deliver targeted electrical stimulation to achieve seizure control. In contrast to current closed-loop systems (RNS), which wait for the seizure to start before delivering stimulation, the BIC system will monitor the spatial topography and rate of stereotyped HFOs and deliver targeted stimulation to these HFO generating areas to prevent seizures from occurring. If the outcomes of our research in an acute setting become successful, the investigators will execute a clinical trial and run the developed methods with the implantable BIC system in a chronic ambulatory setting.
Trial Details
NCT Number NCT05439655
Lead Sponsor Mayo Clinic
Collaborators: Baylor College of Medicine, CorTec GmbH, National Institute of Neurological Disorders and Stroke (NINDS)
Conditions
(from sponsor)		 Epilepsy
Related terms Epilepsy
Enrollment 17 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov