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

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:

Genetics Home Reference related topics: dopa-responsive dystonia early-onset primary dystonia essential tremor Parkinson disease Perry syndrome

MedlinePlus related topics: Dystonia Parkinson's Disease Tremor

U.S. FDA Resources

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 2014
Estimated Primary Completion Date:	January 2014 (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

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:	April 26, 2013
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Tremor
Essential Tremor
Dystonia
Dystonic Disorders
Parkinson Disease
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders

Central Nervous System Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Neurodegenerative Diseases
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013

To Top