Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sensory Gating Measured With Microelectrode Recording (MER) During Deep Brain Stimulation (DBS) Surgery

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.
 
ClinicalTrials.gov Identifier: NCT02320266
Recruitment Status : Recruiting
First Posted : December 19, 2014
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date December 16, 2014
First Posted Date December 19, 2014
Last Update Posted Date September 26, 2019
Study Start Date December 2014
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 1, 2016)
  • Changes in EEG (Measurement in response to paired auditory clicks.) [ Time Frame: 20 min to 2 hours ]
    Measurement in response to paired auditory clicks.
  • Evaluation of SUA (Single unit analysis of brain response.) [ Time Frame: 20 min ]
    Single unit analysis of brain response.
  • Evaluation of LFP (Local field potential of brain response.) [ Time Frame: 20 min ]
    Local field potential of brain response.
Original Primary Outcome Measures
 (submitted: December 18, 2014)
  • EEG (Measurement in response to paired auditory clicks.) [ Time Frame: 20 min to 2 hours ]
    Measurement in response to paired auditory clicks.
  • SUA (Single unit analysis of brain response.) [ Time Frame: 20 min ]
    Single unit analysis of brain response.
  • LFP (Local field potential of brain response.) [ Time Frame: 20 min ]
    Local field potential of brain response.
Change History Complete list of historical versions of study NCT02320266 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Sensory Gating Measured With Microelectrode Recording (MER) During Deep Brain Stimulation (DBS) Surgery
Official Title Sensory Gating Measured With Microelectrode Recording During Deep Brain Stimulation Surgery
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), Dystonia and Obsessive Compulsive disorder (OCD). Over 100,000 patients worldwide have now been implanted with DBS devices. Current approved methods to locate the DBS target regions in the brain use a combination of stereotactic imaging techniques and measurements of the electrical activity of brain cells. As part of the standard clinical technique, electrical data are collected from individual nerve cells. The target brain region emits unique electrical signals. At certain brain locations, during DBS surgery, additional electrical data that are generated in response to sound will be collected. Regions of the brain that have a decreased response to repeated sound (auditory gating) may be important DBS targets for improving thinking. The aims are (i) during DBS surgery, in addition to EEG, use microelectrodes in the brain to find brain regions, along the normal path to the DBS target, where auditory gating occurs and then (ii) determine if stimulation of the identified region(s) alters auditory gating measured by EEG. Also an additional aim (iii) is to measure electrical activity at the scalp with EEG to characterize auditory gating in patients before and after DBS surgery and also a healthy control population.
Detailed Description 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), Dystonia and Obsessive Compulsive disorder (OCD). Over 100,000 patients worldwide have now been implanted with DBS devices. Current approved methods to locate the DBS target regions in the brain (subthalamic nucleus (STN) for PD) use a combination of stereotactic imaging techniques and measurements of the electrical activity of brain cells. As part of the standard clinical technique, electrical data are collected from individual nerve cells --in a procedure called microelectrode recording (MER). The target brain region emits unique electrical signals that are detected by MER during the standard DBS surgery. MER is done at stops along the way to the target. At the stops during DBS surgery, additional electrical data that are generated in response to sound will be collected. Regions of the brain that have a decreased response after repeated sound (auditory gating) may be important DBS targets for improving thinking. The aims are to:(Aim 1A) during DBS surgery, in addition to EEG, use microelectrodes in the brain to measure electrical activity with single unit activity (SUA) and local field potentials (LFP) to find brain regions along the path to the DBS target where auditory gating occurs (Aim 1A) and then determine if stimulation of the identified region(s) alters auditory gating measured by EEG(Aim 1B); and (Aim 2) measure electrical activity at the scalp with electroencephalography (EEG) to characterize auditory gating in patients before and after DBS surgery and also a healthy control population.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects with Parkinson's Disease who are planning to undergo DBS surgery. Age matched controls without Parkinson's Disease or a history of mental illness.
Condition
  • Parkinson's Disease
  • Essential Tremor
  • Dystonia
  • Obsessive Compulsive Disorder
Intervention Not Provided
Study Groups/Cohorts
  • Parkinson's Disease
    Patients diagnosed with Parkinson's Disease undergoing DBS surgery.
  • Control
    Age matched controls without Parkinson's Disease and no history of mental illness.
  • Essential Tremor
    Patients diagnosed with Essential Tremor undergoing DBS surgery.
  • Dystonia
    Patients diagnosed with Dystonia undergoing DBS surgery.
  • Obsessive-Compulsive disorder
    Patients diagnosed with Obsessive-Compulsive disorder undergoing DBS surgery.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 18, 2014)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • subjects with Parkinson's Disease planning to undergo DBS surgery
  • subjects without Parkinson's Disease
  • subjects without a history of mental illness.

Exclusion Criteria:

  • subjects with hearing impairment
  • illicit drug use
  • marijuana use
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Pamela David Gerecht, Ph.D. 303-724-4134 pamela.davidgerecht@ucdenver.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02320266
Other Study ID Numbers 14-0358
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Colorado, Denver
Study Sponsor University of Colorado, Denver
Collaborators Not Provided
Investigators
Principal Investigator: Judith M Gault, Ph.D. University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date September 2019