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

Sponsor
University of Colorado, Denver (Other)
Overall Status
Recruiting
CT.gov ID
NCT02320266
Collaborator
(none)
150
1
87
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Sensory Gating Measured With Microelectrode Recording During Deep Brain Stimulation Surgery
    Study Start Date :
    Dec 1, 2014
    Anticipated Primary Completion Date :
    Dec 1, 2021
    Anticipated Study Completion Date :
    Mar 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Changes in EEG (Measurement in response to paired auditory clicks.) [20 min to 2 hours]

      Measurement in response to paired auditory clicks.

    2. Evaluation of SUA (Single unit analysis of brain response.) [20 min]

      Single unit analysis of brain response.

    3. Evaluation of LFP (Local field potential of brain response.) [20 min]

      Local field potential of brain response.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Colorado Aurora Colorado United States 80045

    Sponsors and Collaborators

    • University of Colorado, Denver

    Investigators

    • Principal Investigator: Judith M Gault, Ph.D., University of Colorado, Denver

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT02320266
    Other Study ID Numbers:
    • 14-0358
    First Posted:
    Dec 19, 2014
    Last Update Posted:
    Feb 9, 2021
    Last Verified:
    Feb 1, 2021
    Keywords provided by University of Colorado, Denver
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 9, 2021