Implanting electrical contact points to treat Parkinson's disease

The hypothesis underlying this project is that determining the optimal contact point or combination of contact points for DBS (Deep Brain Stimulation) in Parkinson's disease can be based on imaging alone and clinical threshold assessment can be omitted. This led to a randomized controlled trial for to compare DBS programming based on imaging alone with DBS programming based on threshold assessment. The result of the study could be implemented immediately and could change clinical practice worldwide.

The purpose of the study is to assess whether the effectiveness of DBS for Parkinson's disease using DBS programming using imaging-based contact point selection is non-inferior to DBS programming with the current standard practice of threshold assessment-based contact point selection. The study will have a non-inferiority prospective randomized open blinded endpoint (PROBE) design. 112 patients with advanced Parkinson's disease who are candidates for DBS will be enrolled.

The informed consent procedure takes place before DBS surgery. Patients undergo their DBS surgery in the usual clinical setting. After electrode implantation, patients are randomly assigned, in a 1:1 ratio by a central Web-based computer program, to imaging-assisted contact point selection (i.e., the imaging-assisted group) or threshold-based contact point selection (i.e., the usual-care group).