RecruitingNot ApplicableNCT04650932

Dual Frequency Stimulation in Parkinson's Disease

Dual Frequency, Dual Region Deep Brain Stimulation of the Subthalamic Nucleus in Parkinson's Disease

Sponsor

University of California, Davis

Enrollment

10 participants

Start Date

Oct 22, 2022

Study Type

INTERVENTIONAL

Conditions

Parkinson Disease

Summary

Deep brain stimulation (DBS) in the dorsal region of the subthalamic nucleus (STN) is very effective for reducing motor symptoms of Parkinson's disease (PD). Modeling studies suggest that this therapy may result in current spread into the ventral STN, causing altered cognitive processes. As a result, current stimulation parameters often lead to worsening in verbal fluency, executive function, and, particularly, cognitive control. There is evidence suggesting that low frequency oscillatory activity occurs across brain circuits important in integrating information for cognition. Preclinical studies and human recording studies indicate these low frequency theta oscillations drive cognitive control during cognitive tasks. Thus, the purpose of this study is to determine the safety, tolerability, and efficacy of low frequency stimulation (LFS) of the ventral STN alongside standard high frequency stimulation (HFS) of the dorsal STN in patients with PD.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new way of programming deep brain stimulation (DBS) devices in people with advanced Parkinson's disease, using two different electrical frequencies at the same time to try to improve both movement and thinking. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of Parkinson's disease - You previously had a specific brand of DBS device implanted (Boston Scientific Vercise) - Your DBS device has been in place for at least 3 months - You had bilateral DBS surgery in a specific brain region (the subthalamic nucleus) **You may NOT be eligible if...** - You are unable to give consent - You have significant cognitive or physical difficulties that would prevent participation in mental tests - Your cognitive score (MoCA-Blind) is below 15 - Your depression score is high (above 20 on the CES-D scale) - You are pregnant - You do not speak English 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

DEVICEDeep brain stimulation

Patients with idiopathic Parkinson's disease who have previously been implanted with the Boston Scientific VerciseTM DBS system for at least 3 months. These patients will already be receiving high-frequency dorsal STN stimulation as part of the standard of care for PD. Once patients have provided consent and are enrolled in this study, they will receive simultaneous low-frequency stimulation of the ventral STN to examine if there are any effects on cognitive performance.