Overview

The purpose of the study is to determine whether new deep brain stimulation (DBS) device technologies can generate and record brain rhythms to reveal the best location for clinical stimulation.

Eligibility

Inclusion Criteria:

1. Age >18 years and older
2. Clinically definite, advanced idiopathic PD based on at least 2 of 3 cardinal PD features
3. Disease duration of 4 years or more
4. Participant has elected to undergo awake DBS surgery as part of routine care, and the subthalamic nucleus (STN) or globus pallidus interna (GPi) are recommended by the multidisciplinary DBS committee as the surgical target.
5. Participant is healthy enough to undergo surgery and the research protocol
6. Normal, or essentially normal, preoperative brain MRI, except for expected mild abnormalities associated with advanced PD
7. Willingness and ability to cooperate during awake DBS surgery, as well as during post-operative evaluations, adjustments of medications and stimulator settings
8. Participant's health insurance and/or Medicare covers DBS surgery as part of routine care
9. Refractory motor symptoms such as tremors, dyskinesias, wearing off, and/or motor fluctuations, causing significant disability or occupational dysfunction, despite reasonable attempts at medical management, as determined by our consensus DBS committee
10. Stable doses of PD medications for at least 28 days prior to baseline assessments
11. Improvement of motor signs ≥30% with dopaminergic medication as assessed with the use of the Movement Disorders - Unified Parkinson's Disease Rating Scale, part III as performed at baseline visit
12. Disease severity ratings above Hoehn and Yahr stage 1, defined as unilateral involvement only with minimal or no functional disability, with scores ranging from 0 to 5 and higher scores indicating more severe disease as performed at baseline visit.
13. Score of more than 6 for activities of daily living in the worst "off" medication condition despite medical treatment, as assessed with the use of the MDS-UPDRS II, or mild-to-moderate impairment in social and occupational functioning as performed at baseline visit
14. Dementia Rating Scale-2 score of ≥130 on medications from routine care record review
15. Beck Depression Inventory II score of ≤25 on medications as performed at baseline visit
16. Participant expresses understanding of the consent process, terms of the study protocol, is available for follow-up over the length of the study, and signs informed consent

Exclusion Criteria:

1. Age <18 years
2. Participant's insurance will not cover the costs of surgery with an investigational device (Future exclusion for pending Aims 2 and 3 only)
3. Medical contraindications such as current uncontrolled hypertension, heart disease, coagulopathy, or other conditions contraindicating DBS surgery or stimulation
4. Duration of disease of <4 years
5. Diagnosis or suspicion of atypical parkinsonism or drug-induced parkinsonism, or significant neurological disease other than Parkinson's disease
6. Diagnosis of psychogenic movement disorder based on consensus criteria
7. Patient is undergoing DBS electrode placement under general anesthesia without awake electrophysiological and clinical testing during implant
8. Score of >25 on the Beck Depression Inventory II or history of suicide attempt
9. Any current acute psychosis, alcohol abuse or drug abuse
10. Clinical dementia
11. Ongoing or pervasive impulse control disorder not resolved by reduction of dopaminergic medications
12. Use of anticoagulant medications that cannot be discontinued during perioperative period
13. History of hemorrhagic stroke
14. Current or future risk of immunocompromise that might significantly increase infection risk
15. History of recurrent of unprovoked seizures
16. Lack of clear levodopa responsiveness
17. The presence of an implanted device whether turned on or off.
18. Prior DBS surgery or ablation within the affected basal ganglion
19. Prior DBS surgery on the opposite side of the brain (future pending Aims 2 and 3 only)
20. A condition requiring or likely to require the use of diathermy
21. Structural lesions such as basal ganglionic stroke, tumor, or vascular malformation as etiology of the movement disorder
22. Any medical or psychological problem that would interfere with completing the study protocol, as determined by the research team
23. A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test