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Intraoperative Microelectrode Recordings Using MAVEN Compared to Standard Recording Apparatuses

NCT07868614 — Recruiting, 30 participants, Mayo Clinic

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RegistryNCT07868614
StatusRecruiting
Study typeObservational
Enrollment30 (Estimated)
SponsorMayo Clinic (Other)
ConditionsEssential Tremor, Parkinson's Disease, Dystonia
InterventionsMultifunctional Apparatus for Voltammetry, Electrophysiology, and Neuromodulation (MAVEN) (Device)
Datesstart 2025-07-29, primary completion 2028-12-01 (estimated), completion 2028-12-01 (estimated), first posted 2026-10-09, last updated 2026-10-09
Locations1 site in United States

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-Summary

The purpose of this research is to determine if the electrophysiologic data collected from standard-of-care microelectrode recordings during human deep brain stimulation (DBS) surgery will be the same using the MAVEN device compared with the standard Alpha Omega device with either a tungsten standard-of-care microelectrode (for microelectrode recordings), or a carbon-fiber microelectrode (for neurotransmitter recordings). The number of microelectrodes used for both the tungsten and the carbon-fiber version will be the same as the standard-of-care.

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+Arms and interventions

ArmTypeInterventionsDescription
Tungsten fiber microelectrodeDevice: Multifunctional Apparatus for Voltammetry, Electrophysiology, and Neuromodulation (MAVEN)Standard of care Tungsten microelectrode and cables will be utilized, and a splitter adaptor cable will route the data to both the standard Alpha Omega device and also to MAVEN, for comparison of MER readings.
Carbon fiber microelectrodeDevice: Multifunctional Apparatus for Voltammetry, Electrophysiology, and Neuromodulation (MAVEN)A carbon fiber microelectrode will be utilized (in lieu of the tungsten microelectrode) and a splitter adaptor cable will route the data to both the standard Alpha Omega device and also to MAVEN, for comparison of MER readings.
  • Multifunctional Apparatus for Voltammetry, Electrophysiology, and Neuromodulation (MAVEN) (Device): During deep brain stimulation (DBS) surgery, the MAVEN device will be used in parallel with the currently used Alpha Omega Device to compare the quality of electrophysiologic readings.

+Outcome measures

Primary outcomes

  • Agreement between MAVEN device and Alpha Omega device [Baseline]: Total number of times the MAVEN device is in agreement with the standard of care Alpha Omega device.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Mayo Clinic patients already scheduled to undergo DBS surgery with Dr. Kendall Lee fora movement disorder.

Exclusion Criteria:

* Patients not approved for DBS surgery by the multidisciplinary DBS committee.

+Locations (1)

FacilityCityCountryStatus
Mayo ClinicRochester, MinnesotaUnited StatesRecruiting

+Investigators

My Notes