Local Fields Potentials Recorded From Deep Brain Stimulating Electrodes

NCT02071446 | Completed

• 1 other identifier: 13-3197
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease; Essential Tremor; Dystonia

Keywords

Deep Brain Stimulation; Local Field Potential; Subthalamic Nucleus

Outcome Measures

Primary Outcomes (1)

• Recording and evaluating LFPs from DBS electrodes

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

  at baseline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Movement disorder patients from primary care clinic.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• University of Houston: collaborator
• U.S. National Science Foundation: collaborator

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Essential Tremor; Dystonia

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aviva Abosch, MD, PhD.

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2014
• First Posted: February 25, 2014
• Study Start: March 1, 2014
• Primary Completion: November 29, 2017
• Study Completion: November 29, 2017
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

US (1)