NCT01355835

Combined STN/SNr-DBS for the Treatment of Refractory Gait Disorders in Parkinson's Disease

Combined STN/SNr-DBS for the Treatment of Refractory Gait Disorders in Parkinson's Disease: Design of a Two-armed Double-blind Cross-over Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

12 patients with idiopathic Parkinson's disease and refractory gait disturbances under best individual subthalamic nucleus stimulation and dopaminergic medication will be included into this randomised double-blind cross-over two-armed clinical trial. The treatment consists of two different stimulation settings using (i) conventional stimulation of the subthalamic nucleus \[STNmono\] and (ii) combined stimulation of distant electrode contacts located in the subthalamic nucleus and caudal border zone of STN and substantia nigra pars reticulata \[STN+SNr\].

Detailed description

A composite 'axial score' including the major clinical and anamnestic items on gait, posture and balance function from UPDRSII (items 13-15) and UPDRS III (items 27-31) constitutes the primary outcome measure. Secondary outcome measures include specified clinical and anamnestic assessments on freezing of gait, balance, quality of life, non-motor symptoms, impulsivity, impulse control and neuropsychiatric symptoms. The aim of the present trial is to investigate the efficacy and safety of combined stimulation on subthalamic and nigral electrode contacts \[STN+SNr\] in refractory hypokinetic gait disturbances compared with \[STNmono\] (active comparator). The results will clarify, whether the combined \[STN+SNr\] stimulation improves otherwise refractory gait disturbances in PD.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DEVICE	deep brain stimulation (ACTIVA PC, Medtronic)	High frequent deep brain stimulation with variable (best individual) stimulation on subthalamic contacts and standard parameters on nigral contacts (125 Hz, 60µs, best individual amplitude)

Timeline

• Start date: 2011-02-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2011-05-18
• Last updated: 2012-08-08

Locations

1 site across 1 country: Germany