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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Colorado, Denver
Sponsor:
Collaborators:
University of Houston
U.S. National Science Foundation
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT02071446
First received: February 21, 2014
Last updated: August 15, 2014
Last verified: August 2014
  Purpose

Deep Brain Stimulation 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. We 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. We will measure these Local Field Potentials, LFPs, representing the activity of the collection of neurons in the brain surrounding the tip of the electrode, during surgery 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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 candidates for 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 who are not candidates for DBS surgery, based on clinical criteria.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02071446

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

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02071446     History of Changes
Other Study ID Numbers: 13-3197
Study First Received: February 21, 2014
Last Updated: August 15, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 23, 2014