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OpenTrials
Completed

NCT Number: NCT02071446

Local Fields Potentials Recorded From Deep Brain Stimulating Electrodes

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.

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Key information

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. Recording and evaluating LFPs from DBS electrodes

    Time frame: at baseline

    Recording and evaluating LFPs from DBS electrodes in patients with Parkinson's Disease, Essential Tremor or Dystonia

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • U.S. National Science Foundation
  • University of Houston

Registry information

Official study title

Local Field Potentials Recorded From Deep Brain Stimulating Electrodes Implanted for the Treatment of Parkinson's Disease, Essential Tremor or Dystonia

Acronym: LFP DBS

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Feb 25, 2014
Registry last updated
Jan 23, 2018

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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