Dual frequency stimulation for improving Parkinson's disease symptoms
Dual Frequency, Dual Region Deep Brain Stimulation of the Subthalamic Nucleus in Parkinson's Disease
NA · University of California, Davis · NCT04650932
This study is testing if a new way of combining two types of brain stimulation can help people with advanced Parkinson's disease feel better while reducing side effects from standard treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Davis (other) |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT04650932 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of combining low frequency stimulation (LFS) of the ventral subthalamic nucleus (STN) with standard high frequency stimulation (HFS) of the dorsal STN in patients with Parkinson's disease. The aim is to assess the safety, tolerability, and efficacy of this dual stimulation approach, which may help mitigate cognitive side effects associated with traditional DBS therapy. Participants must have previously undergone DBS implantation and be diagnosed with advanced Parkinson's disease. The study will evaluate cognitive control and other cognitive processes during stimulation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with idiopathic Parkinson's disease who have been implanted with the Boston Scientific VerciseTM DBS system for at least 3 months.
Not a fit: Patients with significant cognitive or physical impairments that limit their ability to participate in cognitive testing may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance cognitive function in patients with Parkinson's disease while still providing motor symptom relief.
How similar studies have performed: While deep brain stimulation is a well-established treatment for Parkinson's disease, the specific combination of dual frequency stimulation is a novel approach that has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Sacramento, California
- UC Davis Health — Sacramento, California, United States (RECRUITING)
Study contacts
- Principal investigator: Kiarash Shahlaie, MD, PhD — University of California, Davis
- Study coordinator: Kiarash Shahlaie, MD, PhD
- Email: krshahlaie@ucdavis.edu
- Phone: 916-703-5505
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Parkinson Disease, DBS, Deep Brain Stimulation, STN, Subthalamic Nucleus, Parkinson disease, Dual frequency, Dual region