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

Trial ID: NCT04650932

Interventional - Phase Unknown - Recruiting

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.

Conditions

• Parkinson Disease

Interventions

• Deep brain stimulation

Eligibility

Inclusion criteria

• Individuals who are 18 years and older
• Individuals with idiopathic Parkinson's Disease who previously underwent implantation with the Boston Scientific VerciseTM DBS system
• Individuals who have been implanted with the Boston Scientific VerciseTM DBS system for at least 3 months
• Individuals diagnosed with advanced PD who had bilateral dorsal subthalamic nucleus DBS surgery, as standard of care for motor improvement, with distal contacts of the electrodes implanted into the ventral STN

Exclusion criteria

• Individuals unable to provide consent and/or lack capacity to consent
• Individuals diagnosed with any cognitive or physical impairments that would limit their ability to participate in the cognitive testing
• Individuals who score below 15 on the Montreal Cognitive Assessment Test-Blind
• Individuals who score above 20 on the Center for Epidemiologic Studies Depression Scale
• Pregnant women (note: pregnant women are not candidates for DBS surgery), and prisoners
• Non-English speaking individuals. Cognitive tasks will only be conducted in English.

Sponsor

University of California, Davis

Source: ClinicalTrials.gov

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