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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Microelectrode Recordings Using MAVEN Compared to Standard Recording Apparatuses
- ClinicalTrials.gov ID
- NCT07868614
- Acronym / sponsor ID
- 24-008786
- Conditions
- Essential Tremor, Parkinson's Disease, Dystonia
- Keywords
- Deep brain stimulation surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 29 Jul 2025 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tungsten fiber microelectrode | – | Device: 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 microelectrode | – | Device: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mayo Clinic patients undergoing deep brain stimulation (DBS) surgery with Dr. Kendall Lee.
Key inclusion criteria (1 listed)
- Mayo Clinic patients already scheduled to undergo DBS surgery with Dr. Kendall Lee fora movement disorder.
Key exclusion criteria (1 listed)
- Patients not approved for DBS surgery by the multidisciplinary DBS committee.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multifunctional Apparatus for Voltammetry, Electrophysiology, and Neuromodulation (MAVEN)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. | Device | Carbon fiber microelectrode, Tungsten fiber microelectrode |
Primary outcome
Agreement between MAVEN device and Alpha Omega device
Time frame: Baseline
Total number of times the MAVEN device is in agreement with the standard of care Alpha Omega device.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kendall Lee, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Essential Tremor and Parkinson's Disease, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neurosurgery Study Team (507-293-7354, lee.kendall@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between MAVEN device and Alpha Omega device (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.