Neurotransmitter Measurements Using (WINCS) During Deep Brain Stimulation Neurosurgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Kendall H. Lee, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01705301
First received: October 9, 2012
Last updated: May 22, 2015
Last verified: May 2015

October 9, 2012
May 22, 2015
January 2010
January 2016   (final data collection date for primary outcome measure)
adenosine release in brain as measured by WINCS (Wireless Instantaneous Neurochemical Concentration Sensing System)recording device [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
Pre, during, post DBS (deep brain stimulation)
Same as current
Complete list of historical versions of study NCT01705301 on ClinicalTrials.gov Archive Site
dopamine release in brain as measured by WINCS (Wireless Instantaneous Neurochemical Concentration Sensing System)recording device [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
Pre, during, post DBS (deep brain stimulation)
Same as current
Not Provided
Not Provided
 
Neurotransmitter Measurements Using (WINCS) During Deep Brain Stimulation Neurosurgery
Neurotransmitter Measurements Using Wireless Instantaneous Neurotransmitter Concentration System (WINCS) During Deep Brain Stimulation Neurosurgery.

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?

In this study, we 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 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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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.

  • Essential Tremor
  • Parkinson's Disease
  • Dystonia
Device: WINCS
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
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
Intervention: Device: WINCS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
January 2016
January 2016   (final data collection date for primary outcome measure)

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:

  • pregnant patients,
  • prisoners,
  • children (age less than 18), and
  • any patients identified as unsuitable for these protocol by the Mayo DBS committee.
Both
18 Years to 90 Years
No
Contact: Paul Min, PhD min.paul@mayo.edu
Contact: Kendall Lee, MD, PhD
United States
 
NCT01705301
09-007441
No
Kendall H. Lee, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Kendall Lee, MD, PhD Mayo Clinic
Mayo Clinic
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP