NCT06872203

LFP Sensing From Directional Leads in the Acute Clinical Setting

LFP Sensing From Directional Leads and Associated Clinical Outcomes in the Acute Clinical Setting

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 10 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study plans to learn more about the optimal way to program the Medtronic Deep Brain Stimulation system in patients with Parkinson's Disease.

Detailed description

The investigators will conduct a prospective study in patients with Parkinson's disease (PD) implanted with standard of care, subthalamic nucleus (STN) deep brain stimulation (DBS) electrodes, to test whether monopolar sensing of the maximal power in the beta frequency range (in STN) predicts the optimal therapeutic stimulation setting for alleviation of PD motor symptoms. Participants in this study will have been implanted with a Medtronic DBS system consisting of a PerceptTM PC neurostimulator (battery) and SenSight™ DBS leads (implanted electrodes) with BrainSenseTM technology. The DBS surgery is a standard of care procedure, and no alteration of the surgical plan will occur for research purposes . The ranked response between the clinical profile (therapeutic benefit and adverse effects) and beta power will be compared for all electrical contacts on the implanted electrode. Additional analysis of monopolar sensing compared to differential bipolar sensing, location/distance and volume of neural activation (VNA) of optimal contacts identified by beta power or therapeutic window will be estimated with respect to the STN. Aim 1- Determine whether monopolar sensing of beta power, in the outpatient clinic setting, will predict the optimal therapeutic contact for electrical stimulation of the STN. Aim 2 - Long Term Follow Up (\>12 months) of the same consented study participants to determine the stability of the beta power to determine the optimal contact for therapeutic stimulation.

Conditions

• Parkinson Disease, Idiopathic
• Parkinson Disease

Interventions

Type	Name	Description
DEVICE	Deep brain stimulation	Deep Brain Stimulation programming

Timeline

• Start date: 2022-06-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2025-03-12
• Last updated: 2025-03-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study