Session Information
Date: Thursday, June 8, 2017
Session Title: Parkinson’s Disease: Clinical Trials, Pharmacology And Treatment
Session Time: 1:15pm-2:45pm
Location: Exhibit Hall C
Objective:
The objective of the INTREPID clinical trial is to assess the improvement in motor function and quality of life in patients with advanced, levodopa-responsive Parkinson’s disease (PD) following bilateral subthalamic nucleus Deep Brain Stimulation (DBS) using a new device capable of multiple current sources that provides selective activation of individual contacts on the DBS lead.
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).
Methods:
INTREPID is a multi-center, prospective, double blinded, randomized controlled trial (RCT) sponsored by Boston Scientific Corporation. Subjects with advanced PD were implanted bilaterally in the subthalamic nucleus (STN) with a multiple-source constant current DBS System (Vercise, Boston Scientific). Subjects were randomized to either receive active vs. control settings for a 12 week blinded period. Subjects were blinded to their treatment assignment and study assessments were administered by a clinician blinded to the treatment condition; thus maintaining the double blind in the study. Following completion of a 12-week blinded period, all subjects were programmed to receive best therapeutic settings in the open label period. Motor improvement was evaluated using several assessments including subject motor diaries, UPDRS scores, etc. Assessments for quality of life such as the PDQ-39, SF-36, and functional independence, Schwab and England, were also administered. Adverse events were recorded.
Results:
The INTREPID trial is currently ongoing at over 20 centers in the US. The accompanying report provides the study design, demographics, and other preliminary data.
Conclusions:
INTREPID is the first US double-blinded RCT of a multiple-source, constant-current rechargeable system in PD.
References: Castrioto A. et al. Arch Neurol. 2011 Dec;68(12):1550-6.
To cite this abstract in AMA style:
J. Vitek, R. Jain, P. Starr. INTREPID Trial: A Prospective, Double blinded, Multi-center Randomized Controlled Trial Evaluating Deep Brain Stimulation with a New Multiple-Source, Constant-Current Rechargeable System in Parkinson’s Disease [abstract]. Mov Disord. 2017; 32 (suppl 2). https://www.mdsabstracts.org/abstract/intrepid-trial-a-prospective-double-blinded-multi-center-randomized-controlled-trial-evaluating-deep-brain-stimulation-with-a-new-multiple-source-constant-current-rechargeable-system-in-parkinson/. Accessed June 15, 2025.« Back to 2017 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/intrepid-trial-a-prospective-double-blinded-multi-center-randomized-controlled-trial-evaluating-deep-brain-stimulation-with-a-new-multiple-source-constant-current-rechargeable-system-in-parkinson/