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

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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

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
Parkinson's Disease Essential Tremor Dystonia Obsessive Compulsive Disorder

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.

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Study Type : Observational
Estimated 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 : December 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021


Group/Cohort
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.



Primary Outcome Measures :
  1. Changes in EEG (Measurement in response to paired auditory clicks.) [ Time Frame: 20 min to 2 hours ]
    Measurement in response to paired auditory clicks.

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

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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

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): NCT02320266


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

Locations
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United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Pamela David Gerecht, Ph.D.    303-724-4134    pamela.davidgerecht@ucdenver.edu   
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Judith M Gault, Ph.D. University of Colorado, Denver

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02320266     History of Changes
Other Study ID Numbers: 14-0358
First Posted: December 19, 2014    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Keywords provided by University of Colorado, Denver:
Deep Brain Stimulation Surgery
Additional relevant MeSH terms:
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Parkinson Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Personality Disorders
Mental Disorders
Anxiety Disorders
Dystonia
Essential Tremor
Dyskinesias
Neurologic Manifestations
Signs and Symptoms