INTREPID: A prospective, double-blinded, multicenter randomized controlled trial evaluating deep brain stimulation with a new multiple-source, constant-current rechargeable system in Parkinson's disease

Objective INTREPID is designed to assess the improvement in motor function and quality of life in patients with Parkinson disease (PD) following deep brain stimulation (DBS) using a new device with multiple independent current sources that allowed for activation of individual contacts on the DBS lead, thereby permitting a defined distribution of applied current. Background DBS is an effective treatment for themotor signs and fluctuations associated with PD. Although DBS efficacy has been substantiated by several randomized controlled trials (RCT), the degree of improvement varies significantly. The INTREPID study assessed improvement in motor function and quality of life in patients with PDfollowing bilateral subthalamic nucleus (STN) DBS using a new device with multiple independent current sources. Design/methods INTREPIDis amulticenter, prospective, double‐blinded RCTsponsored by Boston Scientific. Participants were implanted bilaterally in the STN with a multiple source constant current DBS System (Vercise System). Blinded patients were randomized to receive active or control settings for a 12‐week period. All assessments were completed by a blinded assessor. Following the blinded period, participants received their best therapeutic settings. Improvement in motor function and quality of life was evaluated using a PD diary, Unified Parkinson's Disease Rating Scale, 39‐item Parkinson's Disease Questionnaire, and a battery of neuropsychological assessments. Adverse events were recorded. Results The study successfully met the primary endpoint (p < 0.001) with a mean difference of 3.03 ± 4.2 hours from baseline to 12 weeks between the active and the control group in “on” time (PD diary), with no increase in antiparkinsonian medications. The study also met several of the secondary endpoints. The incidence of infection was 2.7% and perioperative intracranial hemorrhage was 1%. Conclusions The results of the INTREPID study demonstrate that the use of a multiple‐source, constant‐current DBS system is safe and effective in the treatment of PD symptoms.