Dual Frequency Stimulation in Parkinson's Disease

University of California (UC) Davis

Status: Enrolling

Conditions: Parkinson Disease

Treatments: Device: Deep brain stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04650932

1633883

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Sustained Dual Frequency, Dual Region, Stimulation

Experimental group

Treatment:

Device: Deep brain stimulation