Electrophysiological Recordings of Deep Brain Stimulation in the Basal Ganglia

Status: Completed
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Parkinson's disease per Queens Square criteria

• Appropriate DBS candidate for multi-disciplinary team consensus

• Age 18 - 85 years of age

• Motor skills allowing for capability to complete evaluations

• Medically cleared for undergoing anesthesia and DBS surgery

Locations
United States
Arizona
St. Joseph's Hospital and Medical Center
Phoenix
Time Frame
Start Date: 2016-02-01
Completion Date: 2022-03
Participants
Target number of participants: 34
Treatments
Other: Deep Brain Stimulation
After informed consent is obtained, the patients will undergo routine DBS pre-operative evaluation and diagnostic testing. This includes a pre-operative 3T-MRI with and without gadolinium as well as pre-operative medical clearance by the patient's PCP or general practitioner and/or other medical specialist if necessary. They will also receive a baseline clinical evaluation including both motor function (Unified Parkinson's Disease Rating Scale on and off anti-parkinsonian medication) quality of life assessment (Parkinson's disease Questionnaire-39) and a full neuropsychological evaluation, if not already completed as part of the routine DBS candidacy evaluation within 2 months of surgery. Subjects will have medical clearance from their specialists and be be evaluated by an internal medicine physician prior to surgery and cleared to proceed.
Sponsors
Collaborators: Arizona State University
Leads: St. Joseph's Hospital and Medical Center, Phoenix

This content was sourced from clinicaltrials.gov