Abstract Details

Title Two Year Outcomes: 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 (INTREPID)

Topic Movement Disorders

Presentation(s) P1 - Poster Session 1 (5:30 PM-6:30 PM)

Poster/Presentation
Number 10-026

Objective The INTREPID clinical trial evaluated the safety and efficacy of bilateral subthalamic nucleus (STN) Deep Brain Stimulation (DBS) for improvement in motor function and quality of life in subjects with advanced, levodopa-responsive Parkinson's disease (PD) using a new multiple-source, constant-current device capable of providing a well-defined distribution of current. Here, we present, two-year follow-up data from the trial.

Background DBS is a safe and effective treatment for 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 has been shown to be sustained for up to 10 years (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 a 12-week blinded period. Post 12-weeks, all subjects received their best therapeutic settings and will be followed up to 5 years. Motor improvement and quality life changes were evaluated using several assessments including PD diary, UPDRS, PDQ-39, etc. Adverse events were collected.

Results The study met the primary endpoint based on a pre-specified cohort of 160 randomized subjects. At 1-year, compared to pre-surgery screening, a 49.2% improvement in UPDRS III scores was reported. A 6-hr improvement in ON time, as measured by the PD diary and overall improvement in quality of life was maintained at 1-year follow up. This report will present 2-year follow up data.

Conclusions

Results of the INTREPID RCT demonstrate that the use of a multiple-source, constant-current DBS system is safe and effective for treatment of Parkinson's disease symptoms.

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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