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Electrophysiological Recordings of Deep Brain Stimulation in the Basal Ganglia

NCT03088592 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2022-10-28

No results posted yet for this study

Summary

The pathology of Parkinson's disease (PD) and the mechanism of Deep Brain Stimulation surgery (DBS) are not completely understood. The recording data that is used routinely as part of the procedure to map the target structures, however, may be analyzed in order to better understand the neural network dynamics in PD. The purpose of the study is to perform simultaneous neural recordings from sub-cortical structures (e.g. subthalamic nucleus \[STN\] or globus pallidus internus \[GPi\]) and the cerebral cortex. These simultaneous recordings may provide insight in the pathology of PD and the mechanism of DBS. The researchers will also study the effects of anesthesia level on neuron synchronization . Recordings with micro-ECoG grid electrodes in the cortex show improved spatial resolution and these will be used to gain better understanding of cortical network dynamics and the synchronization with subcortical structures.

Conditions

  • Parkinson Disease

Interventions

DEVICE

Deep Brain Stimulation

Subjects will have awake or asleep DBS surgery with STN or GPi placement. Microelectrode recordings will define the electrophysiological target prior to lead implantation. Cortical recordings will be done using µECoG grids (2.0 x 0.8 cm) placed over the cortex through the same burr hole used for lead implantation. Neural recordings will be made continuously throughout the procedure: before, during, and after DBS, and at all levels of anesthesia. A pulse generator will be connected and implanted either during the operation or within 7-10 days post-operatively. Subjects will be admitted overnight for observation with anticipated discharge the next morning. The researchers will also be collecting other routine data points (length of surgery, stereotactic accuracy, length of hospital stay, and post-operative complications).

Sponsors & Collaborators

  • Arizona State University

    collaborator OTHER

  • St. Joseph's Hospital and Medical Center, Phoenix

    lead OTHER

Principal Investigators

  • Francisco A Ponce, MD · Barrow Brain and Spine physician with SJHMC privileges

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-01
Primary Completion
2022-03-31
Completion
2022-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03088592 on ClinicalTrials.gov