Concurrent DBS Local Field Potential Analysis and Stimulation in a Closed-Loop Neuromodulation Device
Parkinson's Disease
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's Disease
Eligibility Criteria
Inclusion Criteria:
- Participants who are candidates for DBS surgery.
- Age 22-90 years of age
- Participant is willing to comply with all follow-up evaluations at the specified study time points.
- Participant is able to provide informed consent prior to enrollment in the study.
- The participant is fluent in English.
Exclusion Criteria:
- Significant cognitive impairment or dementia.
- Uncontrolled depression, anxiety or other mood disorder.
- Medical contraindications for general anesthesia, craniotomy, or DBS surgery.
- Diagnosis of acute myocardial infarction or cardiac arrest within previous 6 months.
- Condition requiring diathermy after DBS implantation.
- Subjects with any type of destruction and/or damage to the STN as determined by brain imaging.
- Co-morbid conditions that would interfere with study activities or response to treatment, which may include:
- Life expectancy < 3 years
- Severe Chronic pulmonary disease
- Intractable seizure disorders
- Local, systemic acute or chronic infectious illness
- Life threatening cardiac arrhythmias
- Severe collagen vascular disorder
- Kidney failure or other major organ systems failures
- History of a neurological ablation procedure.
- Labeled contraindication for MRI.
- History of hemorrhagic stroke.
- History of HIV infection or ongoing chronic infection (such as tuberculosis). Participation in another FDA device or medication trial that would interfere with the current study.
Sites / Locations
- The Ohio State University Wexner Medical Center - Center for Neuromodulation
Arms of the Study
Arm 1
Experimental
DBS LFP Activa PC+S
The study aims at testing a slightly modified device (battery) that is similar to the approved system that has the potential of offering future patients a closed loop system with automatic adjustments of stimulation. The purpose of this clinical study is to allow the investigation of local field potential (LFP) signals in patients treated with DBS of the STN. This study will identify common LFP biomarkers observed as a function of disease symptoms, medication effect, fluctuations in disease, and changes resulting from adjustments from current standard practices of DBS programming.