The purpose of this study is to assess the cognitive performance in patients with advanced Parkinson's disease receiving Deep Brain Stimulation (DBS) with settings predetermined clinically to settings derived from a patient-specific computational model.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
80
The GUIDE software uses computer-based models to determine the spread of stimulation from DBS therapy into surrounding nuclei of the brain. The software models stimulation and is not used to program or communicate with the patient's implanted DBS System. The software was recently validated in a multi-center clinical study.
Stimulation parameters clinically determined prior to start of clinical study
University of Florida
Gainesville, Florida, United States
North Shore University Hospital
Manhasset, New York, United States
Evergreen Healthcare
Kirkland, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
sustained improvement in working memory
The primary endpoint of this study is to determine whether or not sustained improvement in working memory can be obtained during DBS with stimulation settings derived from a patient-specific computer-based model (Model) as compared with stimulation settings predetermined clinically (Clinical).
Time frame: 2 Months
Quality of Life (QOL)improvements
The secondary endpoints will evaluate whether or not sustained cognitive improvements translate into other aspects of the patient's life (e.g. mood, activities of daily living, apathy, etc.) during DBS with stimulation settings derived from a patient-specific computer-based model (Model) as compared with stimulation settings predetermined clinically (Clinical).
Time frame: 2 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.