Stimulus-Evoked Directional Field Potentials to Guide Subthalamic and Pallidal DBS for PD
Purpose
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.
Condition
- Parkinson Disease
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Device Feasibility
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Aim 1 - |
Elicit and measure interactions between DBS and target neuronal populations |
|
Recruiting Locations
University of Alabama at Birmingham
Birmingham, Alabama 35233
Birmingham, Alabama 35233
More Details
- Status
- Recruiting
- Sponsor
- University of Alabama at Birmingham
Detailed Description
The investigator's goal is to better understand how deep brain stimulation (DBS) modifies local neuronal activity and to pioneer device technologies that can record local DBS-evoked potentials (DLEPs) to guide therapy. Together, Neuromodulation eXperiment Testbed system (NEXT) with a novel 16-contact directional lead (Argyle) are uniquely suited for these purposes. The investigator's vision is for NEXT to guide both electrode targeting during surgery and programming in clinic, eventually as an integrated component of the implanted pulse generator. The results will inform directional DBS for PD and serve as a model for translation to other diseases where knowledge on DBS circuit interactions is at an even earlier stage.