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

• Conditions: Essential Tremor; Obsessive Compulsive Disorder; Parkinson's Disease; Dystonia

• Registration Number: NCT02320266
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-16
• Study First Submitted QC: 2014-12-18
• Study First Posted: 2014-12-19
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-13
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

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Exclusion Criteria

• subjects with hearing impairment
• illicit drug use
• marijuana use

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of SUA (Single unit analysis of brain response.)	20 min	Single unit analysis of brain response.
Changes in EEG (Measurement in response to paired auditory clicks.)	20 min to 2 hours	Measurement in response to paired auditory clicks.
Evaluation of LFP (Local field potential of brain response.)	20 min	Local field potential of brain response.

Trial Locations

Locations (1)

University of Colorado; 🇺🇸 Aurora, Colorado, United States