Stimulus-Evoked Directional Field Potentials to Guide Subthalamic and Pallidal DBS for PD
- Conditions
- Parkinson Disease
- Interventions
- Device: Neuromodulation eXperiment Testbed system (NEXT) stimulation
- Registration Number
- NCT06169852
- Lead Sponsor
- University of Alabama at Birmingham
- Brief Summary
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.
- Detailed Description
This study is an exploratory single center double-blind, randomized crossover study of unilateral STN versus GPi versus dual-target STN/GPi DBS for motor symptoms of PD. The dual-target approach will allow unique measures of connectivity between STN and GPi, and within-participant clinical contrasts of single target STN, single target GPi, and combined dual-target stimulation. Longitudinal encounters will measure changes in motor function, non-motor function, and patient reported outcomes versus pre-operative baseline in response to each of these stimulation conditions at 4-month intervals after surgery. These blinded encounters will be followed by an unblinded open-label encounter at 16 months utilizing optimized stimulation parameters. In addition to the clinical crossover design, we will retrospectively investigate the extent to which the spatial maps of local DBS-evoked potentials within and across brain targets predict stimulation sites chosen for clinical therapy at either brain target.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 36
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Aim 1 - Neuromodulation eXperiment Testbed system (NEXT) stimulation Elicit and measure interactions between DBS and target neuronal populations
- Primary Outcome Measures
Name Time Method Validate the biological origin of brain signals using an external stimulation/recording system during standard of care Deep Brain Stimulation surgery, both awake and under general anesthesia. At standard of care DBS surgery (awake) and approximately one week later at standard of care battery placement (under general anesthesia). The investigator will validate the biological origin of the signals using pairs of DBS pulses and neural refractoriness with an external stimulation/recording system at therapeutically relevant stimulus amplitudes (i.e., inside and outside the therapeutic window).
Test whether directional DBS leads elicit spatiotemporally distinct oscillations in subthalamic nucleus versus globus pallidus interna. At standard of care DBS surgery (awake) and approximately one week later at standard of care battery placement (under general anesthesia). This investigators efforts will yield granular spatial maps of neural engagement across the two canonical targets for PD to guide targeting (awake or under anesthesia) and clinical programming.
Test whether spatial maps of DBS-evoked oscillations predict clinically effective stimulation sites on a directional DBS lead. At standard of care DBS surgery (awake), approximately one week later at standard of care battery placement (under general anesthesia), at in a research clinical assessment at 16 months after DBS surgery. The investigator will test whether spatial maps of DBS-evoked neural activity predict clinically effective locations for directional DBS.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States