Electrophysiological Recordings of Deep Brain Stimulation in the Basal Ganglia

NCT03088592 | Completed FDA Device

• 1 other identifier: PHX-16-0017-70-06
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Deep Brain Stimulation

Outcome Measures

Primary Outcomes (1)

• Neural Recordings

  Simultaneous neural recordings from sub-cortical structures (e.g. subthalamic nucleus \[STN\] or globus pallidus internus \[GPi\]) and the cerebral cortex will be collected. Recordings include action potentials and local field potentials from sub-cortical structures while subdural microelectrocorticography grids will be used to record local field potential from the cerebral cortex. Time, frequency, and phase relationships between action potentials and local field potentials will also be studied in the context of the level of anesthesia. Analysis of these simultaneous recordings, including assessing any changes, may provide insight in the pathology of PD and the mechanism of DBS.

  pre-operative; intra-operative ; 10-14 post-operative; 12 week post-operative; 6 months post-operative

Study Arms (1)

Deep Brain Stimulation

OTHER

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.

Device: Deep Brain Stimulation

Interventions

Deep Brain Stimulation DEVICE

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).

Also known as: Activa PC Neurostimulator Model 37601 (Medtronic)

Deep Brain Stimulation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Dementia per DSM-V criteria
• Medical or other condition precluding MRI
• History of supraspinal CNS disease other than PD
• Alcohol use of more than 4 drinks per day
• Pregnancy
• History of suicide attempt
• Currently uncontrolled clinically significant depression (BDI\>20)
• History of schizophrenia, delusions, or currently uncontrolled visual hallucinations

Sponsors & Collaborators

• St. Joseph's Hospital and Medical Center, Phoenix: lead
• Arizona State University: collaborator

Study Sites (1)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Francisco A Ponce, MD

  Barrow Brain and Spine physician with SJHMC privileges

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Manager

Study Record Dates

• First Submitted: March 2, 2017
• First Posted: March 23, 2017
• Study Start: February 1, 2016
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: October 28, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)