NCT07868614

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
26mo left

Started Jul 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress36%
Jul 2025Dec 2028

Study Start

First participant enrolled

July 29, 2025

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

October 9, 2026

Status Verified

October 1, 2026

Enrollment Period

3.3 years

First QC Date

October 5, 2026

Last Update Submit

October 5, 2026

Conditions

Keywords

Deep brain stimulation surgery

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.

Device: Multifunctional Apparatus for Voltammetry, Electrophysiology, and Neuromodulation (MAVEN)

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.

Device: Multifunctional Apparatus for Voltammetry, Electrophysiology, and Neuromodulation (MAVEN)

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.

Carbon fiber microelectrodeTungsten fiber microelectrode

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Essential TremorParkinson DiseaseDystonia

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System DiseasesParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesSynucleinopathiesNeurodegenerative DiseasesDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kendall Lee, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Neurosurgery Study Team

CONTACT

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

Locations