Objective: INTREPID is designed to assess the improvement in motor function and quality of life in patients with Parkinson’s disease (PD) following Deep Brain Stimulation (DBS) using a new device with multiple independent current sources that allowed for selective activation of individual contacts on the DBS lead thereby permitting a defined distribution of applied current.

Background: Deep Brain Stimulation (DBS) is an effective treatment for the motor signs and fluctuations associated with Parkinson’s disease (PD). Although DBS efficacy has been substantiated by several randomized controlled trials (RCT), the degree of improvement varies significantly. The INTREPID Trial assessed improvement in motor function and quality of life in PD patients following bilateral subthalamic nucleus (STN) DBS using a new device with multiple independent current sources that allowed for selective activation of individual contacts on the DBS lead thereby permitting a defined distribution of applied current.

Methods: INTREPID is a multicenter, prospective, double blinded RCT sponsored by Boston Scientific. Subjects were implanted bilaterally in the STN with a multiple source constant current DBS System (Vercise System). Blinded subjects were randomized to either receive active vs. control settings for a 12 week period. All assessments were completed by a blinded assessor. Following the blinded period, subjects received their best therapeutic settings. Improvement in motor function and quality of life was evaluated using PD diary, UPDRS, PDQ- 39, 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 control groups 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 peri-operative intracranial hemorrhage was 1%.

Conclusions: The results of the INTREPID Trial demonstrate that the use of a multiple source, constant-current DBS System is safe and effective in the treatment of Parkinson’s disease symptoms.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/intrepid-a-prospective-double-blinded-multicenter-randomized-controlled-trial-evaluating-deep-brain-stimulation-with-a-new-multiple-source-constant-current-rechargeable-system-in-parkinson/