Evaluating brain stimulation effects on cognition in Parkinson's Disease
Theta Burst Subthalamic Nucleus Deep Brain Stimulation for Cognitive and Motor Improvements in Parkinson's Disease
This study is testing if a new type of brain stimulation can improve thinking skills in people with Parkinson's Disease who already have a deep brain stimulator.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Southern California Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT05307055 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of low frequency burst stimulation on cognitive function in individuals with Parkinson's Disease who already have a deep brain stimulator implanted. A total of 32 participants will undergo a randomized double-blind crossover design, where they will experience changes in their stimulation settings and complete neurocognitive assessments. The study will also utilize fMRI scans at baseline and at specified intervals to monitor changes in brain activity. The aim is to compare the effects of theta burst stimulation against standard gamma stimulation on both cognitive and motor performance.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with a history of bilateral STN deep brain stimulation implantation and stable medication regimens.
Not a fit: Patients with a history of epilepsy, dementia, or major substance abuse may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cognitive function in patients with Parkinson's Disease through optimized brain stimulation techniques.
How similar studies have performed: While the approach of using theta burst stimulation is relatively novel, similar studies have shown promise in enhancing cognitive functions through brain stimulation techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female patients who had previously undergone bilateral STN deep brain stimulation implantation 2. Age \>18 years old 3. Stable medication regimen for at least 3 months. 4. Patient informed and able to give written consent 5. Able to comply with all testing, follow-ups and study appointments and protocols Exclusion Criteria: 1. History of epilepsy or seizure 2. History of dementia 3. History of major substance abuse
Where this trial is running
Los Angeles, California
- University of Southern California Keck School of Medicine — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Darrin Lee, MD PhD — University of Southern California, Keck School of Medicine
- Study coordinator: Darrin Lee, MD PhD
- Email: darrin.lee@med.usc.edu
- Phone: 9495220866
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.