NCT03548506

Subthalamic Steering for Therapy Optimization in Parkinson's Disease

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 \[STN\_D\].

Detailed 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).

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DEVICE	Omnidirectional Deep Brain Stimulation of STN	Deep Brain Stimulation
DEVICE	Directional Deep Brain Stimulation of STN	Deep Brain Stimulation

Timeline

• Start date: 2018-04-19
• Primary completion: 2021-12-01
• Completion: 2022-04-01
• First posted: 2018-06-07
• Last updated: 2021-09-29

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated device study