Abstract Details

Title INTREPID: A Prospective, Double Blinded, Multicenter Randomized Controlled Trial Evaluating Deep Brain Stimulation with a New Multiple Source , Constant Current Rechargable System in Parkinson's Disease

Topic Movement Disorders

Presentation(s) ES1 - (-)

Poster/Presentation
Number 001

Objective

Background DBS is an effective treatment for the motor signs and fluctuations associated with PD. Although DBS efficacy has been substantiated by several randomized controlled trials (RCT), the degree of improvement varies significantly. The INTREPID Study 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.

Design/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 versus control settings for a 12 week period. All assessments were completed by a blinded assessor. Following the blinded period, subjects received their best therapuetic settings. Improvement in motor function and quality of life was evaluated using a PD diary, UPDRS, PDQ-39, and a battery of neuropyschological 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 the control group in ON time (PD Diary), with no increase in antiparkisonian 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 Study demonstrate that the use of a multiple source, constant-current DBS system is safe and effective in the treatment of Parkinson's disease symptoms.

Authors/Disclosures
Jerrold Vitek, MD, PhD (UMN Neurology)	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.
	No disclosure on file
Lilly Chen (Boston Scientific)	Lilly Chen has received personal compensation for serving as an employee of Boston Scientific .
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

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