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Local Fields Potentials Recorded From Deep Brain Stimulating Electrodes (LFP in DBS)

This study is currently recruiting participants.
Verified September 2017 by University of Colorado, Denver
Sponsor:
ClinicalTrials.gov Identifier:
NCT02071446
First Posted: February 25, 2014
Last Update Posted: September 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
University of Houston
U.S. National Science Foundation
Information provided by (Responsible Party):
University of Colorado, Denver
  Purpose
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.

Condition
Parkinson's Disease Essential Tremor Dystonia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Local Field Potentials Recorded From Deep Brain Stimulating Electrodes Implanted for the Treatment of Parkinson's Disease, Essential Tremor or Dystonia

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Recording and evaluating LFPs from DBS electrodes in patients with Parkinson's Disease, Essential Tremor or Dystonia [ Time Frame: at baseline ]

Estimated Enrollment: 50
Study Start Date: March 2014
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Movement disorder patients from primary care clinic.
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02071446


Contacts
Contact: Pamela D Gerecht, PhD 303-724-4134 pamela.davidgerecht@ucdenver.edu

Locations
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Pamela David Gerecht, Ph.D.    303-724-4134    pamela.davidgerecht@ucdenver.edu   
Principal Investigator: Aviva Abosch, MD, Ph.D.         
Sponsors and Collaborators
University of Colorado, Denver
University of Houston
U.S. National Science Foundation
Investigators
Principal Investigator: Aviva Abosch, MD, PhD. University of Colorado, Denver
  More Information

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02071446     History of Changes
Other Study ID Numbers: 13-3197
First Submitted: February 21, 2014
First Posted: February 25, 2014
Last Update Posted: September 29, 2017
Last Verified: September 2017

Keywords provided by University of Colorado, Denver:
Deep Brain Stimulation
Local Field Potential
Subthalamic Nucleus

Additional relevant MeSH terms:
Tremor
Essential Tremor
Parkinson Disease
Dystonia
Dystonic Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations
Signs and Symptoms