NCT07348705

Electrophysiology-based DBS Programming for PD

Electrophysiology-based Deep Brain Stimulation Programming for Parkinson's Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 21 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

Deep brain stimulation (DBS) effectively alleviates motor symptoms in Parkinson's disease (PD). However, current programming is manual and time-consuming. This study will evaluate physiology-based programming using local field potentials (LFPs) to identify optimal stimulation parameters. Specifically, DBS contact selection based on beta power and a broad-band approach will be compared with conventional clinician-based programming.

Detailed description

Up to thirty patients with DBS (unilateral or bilateral leads) attached to a bidirectional implantable pulse generator will be enrolled in this study. This commercially available IPG allows both therapeutic stimulation and chronic sensing. It has been designed to capture local field potentials (LFPs) from implanted DBS leads while delivering stimulation both inside and outside the clinic. After recording LFP data, then, the physician will perform the traditional clinical monopolar review and determine the optimized DBS settings ('clinician-based' settings) following standard clinical procedures, and without looking at the physiology data. In parallel, the LFP data will be analyzed to identify the 'optimal' therapy contact based on 1) maximum beta power, and 2 ) broad-band multi-frequency analysis. The physician will then setup up to 4 stimulation programs will be set up: 1. Clinician-based programming (standard of care), 2. Maximum Beta power-based programming, 3. Broad-band programming. 4. If needed, second-best clinician-based programming (standard of care) In this study, settings 1, 2, and 4 (optional) are determined based on established standards of care or manufacturer guidelines. Setting 3, however, is derived using our novel electrophysiology-based algorithm. While the method for determining this setting is innovative, the resulting parameter may be identical to those obtained through conventional approaches (settings 1, 2, or 4). Therefore, although the methodology introduces a new process, the final settings remain within clinically accepted ranges and do not exceed standard clinician-based practices.

Conditions

• Parkinson's Disease (PD)

Interventions

Type	Name	Description
DEVICE	Clinician-based DBS programming	Contacts, amplitude, pulse width, and frequency are chosen by the treating physician during a conventional monopolar review.
DEVICE	Maximum Beta power-based DBS programming	The contact that shows the strongest beta activity (13-30 Hz) in the local field potentials is selected for stimulation.
DEVICE	Broad-band electrophysiology-based DBS programming	A multi-frequency algorithm that integrates beta, theta/alpha, finely tuned gamma, and other relevant bands is used to identify the optimal contact.

Timeline

• Start date: 2026-01-15
• Primary completion: 2027-01-15
• Completion: 2031-01-15
• First posted: 2026-01-16
• Last updated: 2026-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study