CClinicalTrials.gg
CompletedNCT01705301Updated Aug 3, 2017

Neurotransmitter Measurements Using (WINCS) During Deep Brain Stimulation Neurosurgery

An observational study in Essential Tremor, Parkinson's Disease and Dystonia, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2017-08-03.

Sponsored by Mayo Clinic · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
36
Ages
18 Years to 90 Years
Sex
All
01

Study summary

In this study, the investigators will monitor extracellular neurotransmitter levels using a probe that is able to perform real time electrochemical detection during deep brain stimulation surgery. The overall question this study is designed to answer is: Are there neurotransmitters released during deep brain stimulation?

Read the detailed description

In this study, the investigators will monitor extracellular neurotransmitter levels using a probe that is able to perform realtime electrochemical detection during DBS neurosurgery. The overall question this study is designed to answer is: Are there neurotransmitters released during deep brain stimulation? We propose to enroll 45 patients (15 patients each at the three targets for DBS) with Essential Tremor, Parkinson's Disease, and Dystonia who are undergoing DBS neurosurgery. This will be an acute study. Patients with medically identifiable symptoms of the above diseases who have been approved by Mayo DBS committee for implantation of DBS will be selected for this study. These patients will then be consented preoperatively to undergo extracellular electrophysiology which is typical in these cases to determine the target site for implantation of the DBS electrodes. Following this electrophysiologic procedure, the patient will have electrochemical electrode implanted to (1) determine whether there is adenosine release at the site of stimulation during ventral intermediate nucleus (VIM) thalamic DBS, (2) determine whether there is dopamine and adenosine release within the caudate nucleus or putamen during subthalamic nucleus DBS, and (3) determine whether there is dopamine and adenosine release at the site of stimulation during Globus Pallidus DBS.

02

Conditions studied

  • Essential Tremor
  • Parkinson's Disease
  • Dystonia
03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 36 is below the median of 96 across 1,057 observational studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adult Patients with medically intractable Essential Tremor, Parkinson's Disease, and Dystonia who have been approved for DBS surgery by the interdisciplinary Mayo DBS committee.

Inclusion criteria

  • adult Patients with medically intractable Essential Tremor, Parkinson's Disease, and Dystonia who have been approved for DBS surgery by the interdisciplinary Mayo DBS committee.

Exclusion criteria

Exclusion Criteria:

  • pregnant patients,
  • prisoners,
  • children (age less than 18), and
  • any patients identified as unsuitable for these protocol by the Mayo DBS committee.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
36 participants (actual)
Patient registry
No

Groups and cohorts

  • Deep Brain Stimulation

    Patient's undergoing the clinical procedure of Deep Brain Stimulation will have the experimental protocol that involves, after implantation of the DBS electrodes, a single electrochemical recording electrode, from the WINCS system, implanted along the same trajectory path as the electrophysiology and the DBS electrode

    Device: WINCS

Interventions

  • DeviceWINCS

    The experimental protocol will involve, after implantation of the DBS electrodes, the patient will have a single electrochemical recording electrode will be implanted along the same trajectory path as the electrophysiology and the DBS electrode

06

What researchers measure

Primary outcomes

  1. adenosine release in brain as measured by WINCS (Wireless Instantaneous Neurochemical Concentration Sensing System)recording device

    Pre, during, post DBS (deep brain stimulation)

    Time frame: 30 minutes

Secondary outcomes

  1. dopamine release in brain as measured by WINCS (Wireless Instantaneous Neurochemical Concentration Sensing System)recording device

    Pre, during, post DBS (deep brain stimulation)

    Time frame: 30 minutes

07

Study locations

1 site
  • Mayo Clinic
    Rochester, Minnesota 55901, United States
08

References and documents

Publications

  • Bennet KE, Tomshine JR, Min HK, Manciu FS, Marsh MP, Paek SB, Settell ML, Nicolai EN, Blaha CD, Kouzani AZ, Chang SY, Lee KH. A Diamond-Based Electrode for Detection of Neurochemicals in the Human Brain. Front Hum Neurosci. 2016 Mar 15;10:102. doi: 10.3389/fnhum.2016.00102. eCollection 2016. PubMed 27014033 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01705301
Lead sponsor
Mayo Clinic
Responsible party
Kendall H. Lee (PI, Mayo Clinic) — Principal investigator
First posted
Oct 12, 2012
Start date
Jan 2010
Primary completion
Jul 27, 2017
Completion
Jul 27, 2017
Last update
Aug 3, 2017

Study contacts

Kendall Lee, MD, PhD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion