NCT02588144

Combined Stimulation of STN and SNr for Resistant Freezing of Gait in Parkinson's Disease

Combined Stimulation of Subthalamic Nucleus and Substantia Nigra Pars Reticulata for Resistant Freezing of Gait in Parkinson's Disease: A Randomized Controlled Multicenter Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

54 patients with idiopathic Parkinson's disease and freezing of gait resistant to subthalamic nucleus stimulation and dopaminergic medication will be included into this multicentre randomised controlled double-blinded parallel group clinical trial. The treatment consists of two different stimulation settings using (i) conventional stimulation of the subthalamic nucleus \[standard STN\] as active comparator and (ii) combined stimulation of active electrode contacts located in both the subthalamic nucleus and substantia nigra pars reticulata \[STN+SNr\].

Detailed description

The primary endpoint of this study is to investigate the efficacy and safety of combined \[STN+SNr\] stimulation by "interleaving stimulation" as compared to \[standardSTN\] after 3 months on refractory freezing of gait (FOG). The Trial is designed as superiority study with an 80% power to detect a mean improvement of 4.7 points on the Freezing of Gait Assessment Course (Ziegler et al., 2010) with one-tailed P \< 0.2. To this end 54 patients will be studied. After a common baseline assessment in \[standardSTN\], patients will be randomized to either \[standardSTN\] or \[STN+SNr\] in 1:1 ratio (27 per arm). The primary endpoint assessment is scheduled 90 days from baseline assessment (V6). Additional interim visits are scheduled for secondary purpose from baseline at day 2 (V2), day 8 (V3), day 21 (V4), day 42 (V5). The rationale for this study comes from our previous phase II trial (Weiss et al., 2013) in which we have observed an improvement of freezing of gait from combined STN+SNr stimulation as secondary endpoint compared with standard STN stimulation at three-week follow-up. Secondary outcome measures include anamnestic assessments on freezing of gait and falls, balance, quality of life, neuropsychiatric symptoms and suicidality.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
PROCEDURE	[standard STN]	High frequency deep brain stimulation with variable (best individual) stimulation on subthalamic contacts
PROCEDURE	[STN+SNr]	high frequency deep brain stimulation of combined (best individual) subthalamic and nigral stimulation

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2015-10-27
• Last updated: 2017-06-20

Locations

10 sites across 2 countries: Germany, Luxembourg