RecruitingNot ApplicableNCT06169852

Stimulus-Evoked Directional Field Potentials to Guide Subthalamic and Pallidal DBS for PD

Sponsor

University of Alabama at Birmingham

Enrollment

36 participants

Start Date

Jan 12, 2024

Study Type

INTERVENTIONAL

Conditions

Parkinson Disease

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.

Eligibility

Min Age: 18 YearsMax Age: 89 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a specialized brain recording technique during deep brain stimulation (DBS) surgery for Parkinson's disease. The goal is to use electrical signals generated when the brain is stimulated to better identify the ideal location for placing the DBS device. **You may be eligible if...** - You are over 18 years old with advanced Parkinson's disease (showing at least 2 of the classic features: tremor, rigidity, or slowness of movement) - You have had Parkinson's for 4 or more years - You have been recommended for awake DBS surgery by a specialist team - Your PD motor symptoms have not been well-controlled by medications alone - Your Parkinson's medication improves your motor function by at least 30% - Your health insurance covers DBS surgery as routine care **You may NOT be eligible if...** - Your symptoms do not improve enough with Parkinson's medications - You are unable to cooperate during awake surgery or follow-up - Your brain MRI shows significant abnormalities Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEUnilateral dual-target (STN/GPi) DBS

Participants will be randomly assigned either DBS stimulation in the STN alone, GPi alone, or a combination of stimulation in the STN and GPi.

Locations(1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

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NCT06169852

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