Theta Burst Subthalamic Nucleus Deep Brain Stimulation for Cognitive and Motor Improvements in Parkinson's Disease
University of Southern California
Summary
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.
Description
In this single-center pilot study, the investigators will study both acute and chronic changes to neurocognitive and motor performance in response to interleaving gamma/theta (theta burst) stimulation compared to standard-of-care gamma stimulation. This study will be a randomized double-blinded crossover study. Each patient's baseline voltage intensity will be unchanged. During the first outpatient visit, a baseline assessment (under baseline stimulation parameters, including frequency, pulse width and voltage) consisting of motor and cognitive tests will first be performed. After one week of…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- DeviceSTN DBS - Theta Burst
200 Hz intraburst stimulation for 0.1 second repeated at intervals of 5hz with an existing device
- DeviceSTN DBS - Gamma
Standard of care gamma stimulation with an existing device
Location
- University of Southern California Keck School of MedicineLos Angeles, California