Abstract Details

Title Three-year Follow-up of a Prospective, Double-blinded, Multi-center Randomized Controlled Trial Evaluating Deep Brain Stimulation with Multiple Source, Constant-current Rechargeable System for Treatment of Parkinson’s Disease (INTREPID)

Topic Movement Disorders

Presentation(s) P8 - Poster Session 8 (8:00 AM-9:00 AM)

Poster/Presentation
Number 3-014

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, 3-year follow-up data will be reported.

Background STN-DBS is an established therapeutic option for managing the motor symptoms of Parkinson’s disease. Motor improvement following DBS has been shown to be sustained long term (Castrioto et al. 2011).

Design/Methods 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 weeks. Upon completion of the 12-week blinded period, subjects received their best therapeutic settings in the open-label phase up to 5 years. During long-term follow up, motor improvement and quality of life was evaluated using UPDRS, PDQ39, Schwab and England, etc. Adverse events were also collected.

Results The study met the primary endpoint demonstrated by mean difference of 3.03 ± 4.52 hours (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 2 years, a 46% improvement in UPDRS III scores was reported (sustained since last follow up at 1 year), and overall improvement in quality of life was maintained compared to pre-surgery screening. Three year follow up data will be presented.

Conclusions

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. Long-term follow up on the use of this system and associated outcomes will be presented.

Authors/Disclosures
Jerrold L. Vitek, MD, PhD (UMN Neurology) PRESENTER	Dr. Vitek has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Boston Scientific. Dr. Vitek has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbott. Dr. Vitek has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medtronic. Dr. Vitek has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Surgical Information Sciences. Dr. Vitek has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Surgical Information Sciences. Dr. Vitek has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbott. Dr. Vitek has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Boston Scientific. The institution of Dr. Vitek has received research support from NINDS.
Roshini Jain	Roshini Jain has received personal compensation for serving as an employee of Boston Scientific. Roshini Jain has received stock or an ownership interest from Boston Scientific.
	No disclosure on file
	No disclosure on file

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Abstract Details