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

NCT02320266 | Enrolling By Invitation

• 1 other identifier: 14-0358
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease; Essential Tremor; Dystonia; Obsessive Compulsive Disorder

Keywords

Deep Brain Stimulation Surgery

Outcome Measures

Primary Outcomes (3)

• Changes in EEG (Measurement in response to paired auditory clicks.)

  Measurement in response to paired auditory clicks.

  20 min to 2 hours

• Evaluation of SUA (Single unit analysis of brain response.)

  Single unit analysis of brain response.

  20 min

• Evaluation of LFP (Local field potential of brain response.)

  Local field potential of brain response.

  20 min

Study Arms (5)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Essential Tremor; Dystonia; Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Anxiety Disorders; Mental Disorders

Study Officials

• Judith M Gault, Ph.D.

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: December 19, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: May 13, 2024

Record last verified: 2024-05

Locations

US (1)