Stimulus-Evoked Directional Field Potentials to Guide Subthalamic and Pallidal DBS for PD (NCT06169852)
🩺 Plain-English Summary (8th-Grade Level)
Our goal is to better understand how DBS modifies local neuronal activity and to pioneer device technologies that can record local DBS-evoked potentials (DLEPs) to guide therapy. Our vision is for a patient's unique electrophysiology to guide both electrode targeting during surgery and programming in clinic, eventually as an integrated component of the implanted pulse generator. Our 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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (18 items) and avoid the listed exclusions (27 items).
Location: University of Alabama at Birmingham — Birmingham, Alabama
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion criteria:
- Age \<18 years.
- Participant's insurance will not cover the costs of surgery with an investigational device (Aims 2 and 3 only).
- Medical contraindications such as current uncontrolled hypertension, heart disease, coagulopathy, or other conditions contraindicating DBS surgery or stimulation.
- Duration of disease of \<4 years
- Clinical team suspects patient will need staged contralateral DBS for clinical symptoms within 1 year of unilateral DBS surgery.
- Diagnosis or suspicion of atypical parkinsonism (progressive supranuclear palsy, multiple system atrophy, corticobasal syndrome) or drug-induced parkinsonism, or significant neurological disease other than Parkinson's disease.
- Diagnosis of psychogenic movement disorder based on consensus criteria.
- Dual-target implant cannot be performed safely from a single burr hole because of anatomic constraints or cortical vascular anatomy, based upon the pre-operative neurosurgery plan.
- Patient is undergoing DBS electrode placement under general anesthesia without awake electrophysiological and clinical testing during implant.
- Score of \>25 on the Beck Depression Inventory II, with scores ranging from 0 to 63 and higher scores indicating worse functioning), or history of suicide attempt.
- An indication of suicidal ideation or active suicide planning as assessed on the Columbia-Suicide Severity Rating Scale.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- University of Alabama at Birmingham — Birmingham, Alabama
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.