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Completed

NCT Number: NCT01705301

Neurotransmitter Measurements Using (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?

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

WINCS

Device

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

Primary outcomes

  1. adenosine release in brain as measured by WINCS (Wireless Instantaneous Neurochemical Concentration Sensing System)recording device

    Time frame: 30 minutes

    Pre, during, post DBS (deep brain stimulation)

Secondary outcomes

  1. dopamine release in brain as measured by WINCS (Wireless Instantaneous Neurochemical Concentration Sensing System)recording device

    Time frame: 30 minutes

    Pre, during, post DBS (deep brain stimulation)

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Oct 12, 2012
Registry last updated
Aug 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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