Clinical trial NCT01705301: Neurotransmitter Measurements Using (WINCS) During Deep Brain Stimulation Neurosurgery
Official title: Neurotransmitter Measurements Using Wireless Instantaneous Neurotransmitter Concentration System (WINCS) During Deep Brain Stimulation Neurosurgery.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Essential Tremor
Parkinson's Disease
Dystonia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-10-12
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility 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.

Primary outcomes:
measure: adenosine release in brain as measured by WINCS (Wireless Instantaneous Neurochemical Concentration Sensing System)recording device
timeFrame: 30 minutes
Secondary outcomes:
measure: dopamine release in brain as measured by WINCS (Wireless Instantaneous Neurochemical Concentration Sensing System)recording device
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Kendall Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bennet KE, Tomshine JR, Min HK, Manciu FS, Marsh MP, Paek SB, Settell ML, Nicolai EN, Blaha CD, Kouzani AZ, Chang SY, Lee KH. A Diamond-Based Electrode for Detection of Neurochemicals in the Human Brain. Front Hum Neurosci. 2016 Mar 15;10:102. doi: 10.3389/fnhum.2016.00102. eCollection 2016.