Essential TremorNCT07868614
Intraoperative Microelectrode Recordings Using MAVEN Compared to Standard Recording Apparatuses
An observational study of Essential Tremor and Parkinson's Disease, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Tremor, Parkinson's Disease, Dystonia
- What is being tested?
- Multifunctional Apparatus for Voltammetry, Electrophysiology, and Neuromodulation (MAVEN)
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2025to 1 Dec 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mayo Clinic patients undergoing deep brain stimulation (DBS) surgery with Dr. Kendall Lee.
Who may be able to join
- Mayo Clinic patients already scheduled to undergo DBS surgery with Dr. Kendall Lee fora movement disorder.
Who cannot join
- Patients not approved for DBS surgery by the multidisciplinary DBS committee.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Neurosurgery Study Team, 507-293-7354
Kendall Lee, M.D.
About this study
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.
- Conditions
- Essential Tremor, Parkinson's Disease, Dystonia
- Being tested
- Multifunctional Apparatus for Voltammetry, Electrophysiology, and Neuromodulation (MAVEN)
- Keywords
- Deep brain stimulation surgery
- Medical subject headings
- Essential Tremor, Parkinson Disease, Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Multifunctional Apparatus for Voltammetry, Electrophysiology, and Neuromodulation (MAVEN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start29 Jul 2025
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kendall H. Lee, Mayo Clinic
- Investigators
- Kendall Lee, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868614
- Sponsor's protocol ID
- 24-008786
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No