Intraoperative Microelectrode Recordings Using MAVEN Compared to Standard Recording Apparatuses
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Mayo Clinic patients already scheduled to undergo DBS surgery with Dr. Kendall Lee fora movement disorder.
Disqualifiers
Patients not approved for DBS surgery by the multidisciplinary DBS committee.
Trial population
Mayo Clinic patients undergoing deep brain stimulation (DBS) surgery with Dr. Kendall Lee.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Multifunctional Apparatus for Voltammetry, Electrophysiology, and Neuromodulation (MAVEN)
DeviceDuring 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Tungsten fiber microelectrode1 intervention
Group B: Carbon fiber microelectrode1 intervention
Trial outcomes
Primary outcomes
1
Agreement between MAVEN device and Alpha Omega device
Total number of times the MAVEN device is in agreement with the standard of care Alpha Omega device.
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov