Evaluation of Neurocognitive Changes in Parkinson's Disease After Low Frequency Burst Stimulation
Recruiting · NCT05307055 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Southern California
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This study aims to determine whether direct brain stimulation of specific regions and ranges improves cognition in people with Parkinsons Disease (PD) who already have a deep brain stimulator implanted. Research activities consist of 32 subjects undergoing stimulation changes to their device and being administered neurocognitive tests to evaluate the changes. An fMRI scan will also be done at baseline and at weeks 15 and 27. All subjects will undergo the stimulation changes in a randomized double blind crossover study. Evaluation of stimulation changes will be assessed through analysis of neurocognitive data.
Who can take part
Inclusion criteria
- Male or female patients who had previously undergone bilateral STN deep brain stimulation implantation
- Age \>18 years old
- Stable medication regimen for at least 3 months.
- Patient informed and able to give written consent
- Able to comply with all testing, follow-ups and study appointments and protocols
Exclusion criteria
- History of epilepsy or seizure
- History of dementia
- History of major substance abuse
Where it is running
1 location listed across 1 US state.
- University of Southern California Keck School of Medicine - Los Angeles, California, United States