NCT04650932 Dual Frequency Stimulation in Parkinson's Disease
| NCT ID | NCT04650932 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Davis |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2022-10-22 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2022-10-22 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Kiarash Shahlaie, MD, PhD
PRINCIPAL INVESTIGATOR
University of California, Davis
Frequently Asked Questions
Who can join the NCT04650932 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04650932 currently recruiting?
Yes, NCT04650932 is actively recruiting participants. Contact the research team at krshahlaie@ucdavis.edu for enrollment information.
Where is the NCT04650932 trial being conducted?
This trial is being conducted at Sacramento, United States.
Who is sponsoring the NCT04650932 clinical trial?
NCT04650932 is sponsored by University of California, Davis. The principal investigator is Kiarash Shahlaie, MD, PhD at University of California, Davis. The trial plans to enroll 10 participants.
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