Subthalamic Steering for Therapy Optimization in Parkinson's Disease — SANTOP  

Parkinson Disease Clinical Trial

Official title: Subthalamic Steering for Therapy Optimization in Parkinson's Disease

Status Active, not recruiting

Clinical Trial Summary

Twenty patients with idiopathic Parkinson's disease (PD) will be included into this single center randomized controlled double-blind clinical trial (RCT) in a cross-over design. The treatment consists of two different stimulation settings using (i) conventional omnidirectional stimulation of the subthalamic nucleus [STN_O] as active comparator and (ii) directional steering of STN stimulation via a segmented electrode contact [STN_D].

Clinical Trial Description

Twenty PD patients will be enrolled in this cross-over double-blind RCT to evaluate both the safety and efficacy of directional STN stimulation [STN_D] compared with standard omnidirectional STN stimulation [STN_O]. The primary outcome measure is objectively quantified muscle rigidity of the upper extremity, i.e., surface EMG recordings of the biceps and triceps muscle during standardized extension/flexion of the elbow joint (Levin et al., 2009) assessed 6 months after implantation in cross-over design. The trial is designed to detect with an 80% power a change of 0.27 mA of the therapeutic stimulation threshold with two-tailed P < 0.05 (Wilcoxon rank sum test). Secondary outcome measures address clinical motor, non-motor, neurocognitive and neuropsychiatric symptoms, freezing of gait, and quality of life. Visits are scheduled at weeks 1 (V1), 6 (V2), 24 (V3), 27 (V4), and 30 (V5) from baseline (V0). ;

Related Conditions & MeSH terms

• Parkinson Disease

• NCT number: NCT03548506
• Study type: Interventional
• Source: University Hospital Tuebingen
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 19, 2018
• Completion date: April 2022