Neurotransmitter Measurements Using (WINCS) During Deep Brain Stimulation Neurosurgery
1 other identifier
observational
36
1 country
1
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 9, 2012
CompletedFirst Posted
Study publicly available on registry
October 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 27, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2017
CompletedAugust 3, 2017
August 1, 2017
7.6 years
October 9, 2012
August 1, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
adenosine release in brain as measured by WINCS (Wireless Instantaneous Neurochemical Concentration Sensing System)recording device
Pre, during, post DBS (deep brain stimulation)
30 minutes
Secondary Outcomes (1)
dopamine release in brain as measured by WINCS (Wireless Instantaneous Neurochemical Concentration Sensing System)recording device
30 minutes
Study Arms (1)
Deep Brain Stimulation
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
Interventions
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 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.
You may qualify if:
- 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.
You may not qualify if:
- pregnant patients,
- prisoners,
- children (age less than 18), and
- any patients identified as unsuitable for these protocol by the Mayo DBS committee.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55901, United States
Related Publications (1)
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.
PMID: 27014033DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kendall Lee, MD, PhD
Mayo Clinic
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
October 9, 2012
First Posted
October 12, 2012
Study Start
January 1, 2010
Primary Completion
July 27, 2017
Study Completion
July 27, 2017
Last Updated
August 3, 2017
Record last verified: 2017-08