Intraoperative Microelectrode Recordings Using MAVEN Compared to Standard Recording Apparatuses
1 other identifier
observational
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2025
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 29, 2025
CompletedFirst Submitted
Initial submission to the registry
October 5, 2026
CompletedFirst Posted
Study publicly available on registry
October 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
October 9, 2026
October 1, 2026
3.3 years
October 5, 2026
October 5, 2026
Conditions
Keywords
Outcome Measures
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.
Baseline
Study Arms (2)
Tungsten fiber microelectrode
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 microelectrode
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.
Interventions
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.
Eligibility Criteria
Mayo Clinic patients undergoing deep brain stimulation (DBS) surgery with Dr. Kendall Lee.
You may qualify if:
- Mayo Clinic patients already scheduled to undergo DBS surgery with Dr. Kendall Lee fora movement disorder.
You may not qualify if:
- Patients not approved for DBS surgery by the multidisciplinary DBS committee.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kendall Lee, M.D.
Mayo Clinic
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 5, 2026
First Posted
October 9, 2026
Study Start
July 29, 2025
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
October 9, 2026
Record last verified: 2026-10
Data Sharing
- IPD Sharing
- Will not share