Neurotransmitter Measurements Using Wireless Instantaneous Neurotransmitter Concentration System (WINCS) During Deep Brain Stimulation Neurosurgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Su-Youne Chang, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01705301
First received: October 9, 2012
Last updated: July 16, 2014
Last verified: July 2014
  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 (Wireless Instantaneous Neurochemical Concentration Sensing System)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
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)
Arms Assigned Interventions
Experimental: WINCS
WINCS (Wireless Instantaneous Neurochemical Concentration Sensing System), which is capable of wireless control and data transmission; and in addition is capable of detecting by fast scan cyclic voltametry (FSCV).
Device: WINCS (Wireless Instantaneous Neurochemical Concentration Sensing System)
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55901
Contact: Debra Gorman, RN    507-266-3044    gorman.deborah@mayo.edu   
Principal Investigator: Kendall H Lee, MD, PhD         
Principal Investigator: Su-youne Chang, PhD         
Sponsors and Collaborators
Mayo Clinic
  More Information

No publications provided

Responsible Party: Su-Youne Chang, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01705301     History of Changes
Other Study ID Numbers: 09-007441
Study First Received: October 9, 2012
Last Updated: July 16, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 22, 2014