- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02320266
Sensory Gating Measured With Microelectrode Recording (MER) During Deep Brain Stimulation (DBS) Surgery
March 30, 2023 updated by: University of Colorado, Denver
Sensory Gating Measured With Microelectrode Recording During Deep Brain Stimulation Surgery
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.
Study Overview
Status
Enrolling by invitation
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
Enrollment (Anticipated)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Pamela David Gerecht, Ph.D.
- Phone Number: 303-724-4134
- Email: pamela.davidgerecht@ucdenver.edu
Study Locations
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Parkinson's Disease
Patients diagnosed with Parkinson's Disease undergoing DBS surgery.
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Control
Age matched controls without Parkinson's Disease and no history of mental illness.
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Essential Tremor
Patients diagnosed with Essential Tremor undergoing DBS surgery.
|
Dystonia
Patients diagnosed with Dystonia undergoing DBS surgery.
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Obsessive-Compulsive disorder
Patients diagnosed with Obsessive-Compulsive disorder undergoing DBS surgery.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in EEG (Measurement in response to paired auditory clicks.)
Time Frame: 20 min to 2 hours
|
Measurement in response to paired auditory clicks.
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20 min to 2 hours
|
Evaluation of SUA (Single unit analysis of brain response.)
Time Frame: 20 min
|
Single unit analysis of brain response.
|
20 min
|
Evaluation of LFP (Local field potential of brain response.)
Time Frame: 20 min
|
Local field potential of brain response.
|
20 min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2014
Primary Completion (Anticipated)
December 1, 2024
Study Completion (Anticipated)
December 1, 2025
Study Registration Dates
First Submitted
December 16, 2014
First Submitted That Met QC Criteria
December 18, 2014
First Posted (Estimate)
December 19, 2014
Study Record Updates
Last Update Posted (Actual)
April 3, 2023
Last Update Submitted That Met QC Criteria
March 30, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Anxiety Disorders
- Dyskinesias
- Parkinson Disease
- Obsessive-Compulsive Disorder
- Dystonia
- Essential Tremor
Other Study ID Numbers
- 14-0358
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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