Objective: The objective of the INTREPID clinical trial assessed improvement in motor function and quality of life in patients with advanced, levodopa responsive Parkinson’s disease (PD) following bilateral subthalamic nucleus (STN) Deep Brain Stimulation (DBS) using a new device equipped with multiple current sources. In this analysis, 2-year follow-up data will be reported.

Background: DBS is a surgical therapy used for treatment of the motor signs and fluctuations associated with Parkinson’s disease (PD). Its efficacy has been substantiated by several randomized controlled trials. Moreover,motor improvement following DBS may be sustained for up to 10 years (Castrioto et al. 2011).

Method: INTREPID (ClinicalTrials.gov Identifier: NCT01839396) is a multi-center, prospective, double blinded, randomized controlled trial (RCT) sponsored by Boston Scientific. Subjects with advanced PD were implanted bilaterally in the STN with a multiple-source, constant current DBS System (Vercise, Boston Scientific).Subjects were randomized to either receive active vs. control settings for 12-week blinded period. Subjects were blinded to treatment assignment and study assessments were administered by a clinician blinded to treatment condition. Motor improvement was evaluated using several assessments including subject motor diaries, UPDRS scores, etc. Assessments for quality of life (e.g. PDQ-39) were also administered.

Results: The study met the primary endpoint demonstrated by mean difference of 3.03 ± 4.52 hrs. (p < 0.001)between active and control groups in ON time w/o troublesome dyskinesia, with no increase in antiparkinsonian medication, from post-implant baseline to 12-weeks post-randomization. At 1-year compared to pre-surgery screening, a 49.2% improvement in UPDRS III scores was reported, and overall improvement in quality of life was maintained. Reporting of 2-year follow-up data is planned.

Conclusion: Results of the INTREPID RCT demonstrate that use of a multiple-source, constant-current DBS system is safe and effective for treatment of Parkinson’s disease symptoms. This analysis will describe outcomes derived from subjects assessed out to 2-years follow-up.

References: Castrioto A. et al. Arch Neurol. 2011 Dec;68(12):1550-6.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/intrepid-a-2-year-follow-up-of-a-prospective-double-blinded-multi-center-randomized-controlled-trial-evaluating-deep-brain-stimulation-with-a-new-multiple-source-constant-current-rechargeable-syst/