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

This study is currently recruiting participants.

Verified April 2013 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: April 26, 2013

Last verified: April 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	October 9, 2012
Last Updated Date	April 26, 2013
Start Date ^ICMJE	January 2010
Estimated Primary Completion Date	January 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 11, 2012)	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)
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01705301 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 11, 2012)	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)
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Neurotransmitter Measurements Using Wireless Instantaneous Neurotransmitter Concentration System (WINCS) During Deep Brain Stimulation Neurosurgery
Official Title ^ICMJE	Neurotransmitter Measurements Using Wireless Instantaneous Neurotransmitter Concentration System (WINCS) During Deep Brain Stimulation Neurosurgery.
Brief 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?
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science
Condition ^ICMJE	Essential Tremor Parkinson's Disease Dystonia
Intervention ^ICMJE	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
Study Arm (s)	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)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	45
Estimated Completion Date	January 2014
Estimated Primary Completion Date	January 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 90 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01705301
Other Study ID Numbers ^ICMJE	09-007441
Has Data Monitoring Committee	No
Responsible Party	Su-Youne Chang, Mayo Clinic
Study Sponsor ^ICMJE	Mayo Clinic
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Mayo Clinic
Verification Date	April 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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