Clinical trial NCT02071446: Local Fields Potentials Recorded From Deep Brain Stimulating Electrodes
Official title: Local Field Potentials Recorded From Deep Brain Stimulating Electrodes Implanted for the Treatment of Parkinson's Disease, Essential Tremor or Dystonia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Essential Tremor
Dystonia
Keywords: Deep Brain Stimulation
Local Field Potential
Subthalamic Nucleus
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: University of Houston
name: U.S. National Science Foundation
First posted: 2014-02-25
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Movement disorder patients from primary care clinic.

Brief summary: Deep Brain Stimulation (DBS) is an FDA approved, and widely used method for treating the motor symptoms of Parkinson's Disease (PD), Essential Tremor (ET) and Dystonia. Over 100,000 patients worldwide have now been implanted with DBS devices. The DBS target regions in the brain are the Subthalamic nucleus (STN), the Internal Segment of Globus Pallidus (GPi), or the Ventral Intermediate Nucleus of the Thalamus (VIM). In order to place the DBS electrode in the target location, a combination of two 3D imaging techniques; 3D MRI and CT, are used. Data are also collected from individual nerve cells to help find the best location for the DBS electrode in each patient. This electrode recording takes place during the standard surgical implantation of the DBS electrode, and is part of the standard clinical technique. The investigators plan to collect additional data from populations of neurons during the DBS surgery in an effort to further improve the placement of the DBS electrode. These "Local Field Potentials", LFPs, represent the activity of the collection of neurons surrounding the tip of the electrode, and will be measured during surgery along the path used for the placement of the DBS electrode. The goal of this project is to determine whether this additional data from surrounding neurons will help with optimal placement of the DBS electrode.


Eligibility criteria: Inclusion Criteria:

* Subjects included in this study will be those who are planning to undergo DBS surgery because of their underlying idiopathic Parkinson's disease, Essential Tremor, or Dystonia--all FDA-approved indications for the implantation of DBS devices.

Exclusion Criteria:

* Subjects with the most advanced symptoms of PD (stage V in the Hoehn and Yahr rating scale).
* Subjects who are not planning to undergo DBS surgery.
* Subjects not candidates for DBS surgery based on clinical criteria.

Primary outcomes:
measure: Recording and evaluating LFPs from DBS electrodes
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Aviva Abosch, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References: