Electrophysiological Recordings of Deep Brain Stimulation in the Basal Ganglia

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.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

About this study

Subjects will be identified exclusively from the researchers' clinical practice for evaluation of DBS surgical candidacy for Parkinson's disease. Once it is determined that a patient is an appropriate candidate for DBS placement (multidisciplinary team consensus) and has met inclusion criteria,the researchers will discuss the study with the subject and explain the rationale for the study as well as the implications the subject's participation has to their treatment. Informed consent will be obtained prior to study procedures being performed. Subjects will be in the study from the time of enrollment before surgery until all post-operative visits and tests are completed, usually by 6 months after surgery. Follow-up during this time will consist of the standard follow-up schedule that all patients who undergo DBS follow. This includes a clinic visit at 10-14 days, 12 weeks, and 6 months after DBS surgery. Subjects will also have a follow-up neurocognitive evaluation consisting of the same evaluative tests administered pre-operatively. These post-operative visits are standard for all patients undergoing DBS for Parkinson's.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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).

Other names: Activa PC Neurostimulator Model 37601 (Medtronic)

Primary outcomes

Neural Recordings

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

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.

Sponsors and collaborators

Lead sponsor

St. Joseph's Hospital and Medical Center, Phoenix

Other

Collaborators

Arizona State University

Registry information

Acronym: DBSMER

Important dates

Study start: 2016
Primary completion: 2022
Study completion: 2022
First posted: Mar 23, 2017
Registry last updated: Oct 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed