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

October 9, 2012
July 16, 2014
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 Wireless Instantaneous Neurotransmitter Concentration System (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?

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Essential Tremor
  • Parkinson's Disease
  • Dystonia
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
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).
Intervention: Device: WINCS (Wireless Instantaneous Neurochemical Concentration Sensing System)
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
United States
 
NCT01705301
09-007441
No
Su-Youne Chang, Mayo Clinic
Mayo Clinic
Not Provided
Not Provided
Mayo Clinic
July 2014

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