Stimulating two brain areas to help movement

Intervention: This is an exploratory, randomized, double-blind, self-controlled (crossover) clinical trial, developed as a master's degree project at the International Institute of Neuroscience Edmond and Lily Safra (IIN-ELS), of the Santos Dumont Institute (ISD), in which 10 patients with Parkinson's disease undergoing bilateral deep brain stimulation (DBS) implantation in the subthalamic nucleus (STN) and in the internal globus pallidus (GPi) will participate, with the same 10 participants being submitted, in randomized order, to three deep brain stimulation (DBS) modes dual-target (subthalamic nucleus combined with internal globus pallidus), subthalamic nucleus (STN) alone, and internal globus pallidus (GPi) alone, with each participant serving as their own control, the sequence of presentation of the three modes being defined by a draw performed by the neurologist responsible solely for programming, who will be the only one aware of this information, thereby characterizing a double-blind study, where each experimental cycle will include a programming period for the deep brain stimulation (DBS) parameters with an expected duration of 8 weeks, followed by a stimulation period lasting 14 days, with motor assessments performed in the pre-surgical period and on the last day of each stimulation period, during the ON time (under the effect of levodopa medication), and concluded with the discontinuation of deep brain stimulation (DBS), using as instruments items II and III of the Unified Parkinson's Disease Rating Scale (UPDRS), the Timed-Up and Go test, and the Parkinson's Disease Questionnaire for quality-of-life assessment, with a neuropsychological assessment also being performed using standardized scales to identify cognitive and emotional changes resulting from stimulation, divided into two 50-minute sessions each, using the Montreal Cognitive Assessment (MOCA), the verbal fluency test, the Rey Auditory Verbal Learning Test, the Hamilton Depression Rating Scale (HAM-D), and the Five Digit Test, with possible adverse effects resulting from deep brain stimulation (DBS) also being monitored, in addition to metrics obtained through advanced neuroimaging (voxel-based morphometry, surface-based morphometry, and diffusion tensor imaging) and their correlation with symptomatic improvement after treatment, with the study expected to yield preliminary results that support therapeutic protocols and possibly demonstrate an enhancement of deep brain stimulation (DBS) outcomes for patients with Parkinson's disease Primary outcome: To evaluate the motor response to different deep brain stimulation conditions (dual-target, STN, and GPi) in patients with Parkinson's Disease. Assessed using the Unified Parkinson's Disease Rating Scale – Part III (UPDRS-III) and the Timed-Up and Go (TUG) functional test. Scores obtained on the UPDRS-III and the time, in seconds, recorded on the TUG-Test will be analyzed in each stimulation condition, comparing results across the three arms of the study Secondary outcome: To monitor the cognitive status of individuals following exposure to dual-target stimulation. Using standardized neuropsychological scales, including the Montreal Cognitive Assessment (MoCA), the Verbal Fluency Test, the Rey Auditory Verbal Learning Test, the Hamilton Depression Rating Scale (HAM-D), and the Five Digit Test. Possible changes in the scores of these scales will be observed between the baseline assessment and the assessment following exposure to dual-target stimulation;To monitor perioperative complications and adverse effects related to each stimulation mode. Through continuous clinical follow-up of participants throughout the entire experimental protocol. The number and type of adverse events and perioperative complications observed will be recorded in each arm of the study;To characterize cortical and subcortical structural changes in patients undergoing dual-target deep brain stimulation. Using the voxel-based morphometry (VBM) method based on magnetic resonance imaging. Differences in gray matter volume and density in the evaluated cortical and subcortical regions will be analyzed;To analyze the white matter tracts involved in the subthalamic nucleus (STN) and internal globus pallidus (GPi) circuits. Using tractography based on Diffusion Tensor Imaging. Tract integrity metrics, such as fractional anisotropy, and their correlation with the motor response to stimulation will be observed;To evaluate motor aspects related to activities of daily living under different stimulation conditions. Assessed using the Unified Parkinson's Disease Rating Scale – Part II (UPDRS-II). Scores obtained on the UPDRS-II will be analyzed in each of the three stimulation conditions (dual-target, STN, and GPi);To evaluate the impact on quality of life of different stimulation conditions. Using the Parkinson's Disease Questionnaire (PDQ-39). Scores obtained on the PDQ-39 will be analyzed in each stimulation condition, comparing results across the arms of the study