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
  Purpose

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?


Condition Intervention
Essential Tremor
Parkinson's Disease
Dystonia
Device: WINCS

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neurotransmitter Measurements Using Wireless Instantaneous Neurotransmitter Concentration System (WINCS) During Deep Brain Stimulation Neurosurgery.

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 45
Study Start Date: January 2010
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01705301

Contacts
Contact: Paul Min, PhD min.paul@mayo.edu
Contact: Kendall Lee, MD, PhD

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55901
Contact: Debra Gorman, RN    507-266-3044    gorman.deborah@mayo.edu   
Contact: Cindy Stoppel       stoppel.cynthia@mayo.edu   
Principal Investigator: Kendall H Lee, MD, PhD         
Principal Investigator: Paul Min, PhD         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Kendall Lee, MD, PhD Mayo Clinic
  More Information

No publications provided

Responsible Party: Kendall H. Lee, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01705301     History of Changes
Other Study ID Numbers: 09-007441
Study First Received: October 9, 2012
Last Updated: May 22, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Essential Tremor
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders

ClinicalTrials.gov processed this record on May 27, 2015