Neurotransmitter Measurements Using (WINCS) During Deep Brain Stimulation Neurosurgery

Completed

• Conditions: Parkinson's Disease; Dystonia; Essential Tremor
• Interventions: Device: WINCS

• Registration Number: NCT01705301
• Lead Sponsor: Mayo Clinic

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

In this study, the investigators 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 ventral intermediate nucleus (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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2012-10-09
• Study First Submitted QC: 2012-10-11
• Study First Posted: 2012-10-12
• Primary Completion: 2017-07-27
• Study Completion: 2017-07-27
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-01
• Last Update Posted: 2017-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

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Exclusion Criteria

• pregnant patients,
• prisoners,
• children (age less than 18), and
• any patients identified as unsuitable for these protocol by the Mayo DBS committee.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Deep Brain Stimulation	WINCS	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

Primary Outcome Measures

Name	Time	Method
adenosine release in brain as measured by WINCS (Wireless Instantaneous Neurochemical Concentration Sensing System)recording device	30 minutes	Pre, during, post DBS (deep brain stimulation)

Secondary Outcome Measures

Name	Time	Method
dopamine release in brain as measured by WINCS (Wireless Instantaneous Neurochemical Concentration Sensing System)recording device	30 minutes	Pre, during, post DBS (deep brain stimulation)

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States