Abstract Details

Title Enrollment and Retainment Experiences in a Pilot Clinical Trial Testing Deep Brain Stimulation in Early Stage Parkinson's Disease

Topic Movement Disorders

Presentation(s) P06 - (-)

Poster/Presentation
Number 090

Objective

Background BACKGROUND: We conducted the only FDA-approved study of DBS for early PD (IDE G050016, IRB 040797). Prior to initiation, ethical concerns centered on exposing subjects to surgical risks when their symptoms were well-controlled with medications. Upon commencement, additional concerns were that subjects would either not enroll in the study or be highly motivated to receive DBS and would, therefore, drop out of the study if randomized to medications.

Design/Methods DESIGN/METHODS: 30 subjects (27 men, 60 ± 6.9 mean age) with early stage PD, Hoehn & Yahr ? 2 off medication, without motor fluctuations, were enrolled in a prospective, randomized, single-blind clinical trial testing the safety and tolerability of DBS. 15 subjects randomized to DBS were implanted and followed in parallel with subjects randomized to medications. Subjects were evaluated every 6 months for a period of 2 years. At study completion, 27 subjects completed a survey concerning the enrollment and study experience.

Results RESULTS: Upon enrollment, 89% of subjects hoped to be randomized to DBS. Two medication and one DBS subject considered dropping out following randomization. The only subject to drop out cited financial hardship. The most common reasons for remaining in the study were to help future patients with PD through research participation and to honor their commitment. Two subjects in the medication group elected to undergo DBS after study completion and 3 others are considering DBS.

Conclusions CONCLUSIONS: This study demonstrates that patients will enroll and remain in a trial testing DBS in very early stage PD. While most subjects hoped to be randomized to the DBS group upon study entry, dropouts in either study arm were remarkable low. A large scale multicenter study of DBS in very early stage PD is feasible.

Authors/Disclosures
Anna Molinari (Vanderbilt University) PRESENTER	No disclosure on file
Amanda Currie, MD (Vanderbilt)	Dr. Currie has nothing to disclose.
	No disclosure on file
	No disclosure on file
P. D. Charles, MD, FAAN (Vanderbilt University Medical Center)	Dr. Charles has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Revance. Dr. Charles has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Iota. Dr. Charles has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kyowa Kirin. Dr. Charles has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ceraxis. Dr. Charles has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aspen Neuroscience. Dr. Charles has stock in Arena Therapeutics. The institution of Dr. Charles has received research support from Pharma 2 B. The institution of Dr. Charles has received research support from Intec. The institution of Dr. Charles has received research support from Merz. The institution of Dr. Charles has received research support from Novartis. The institution of Dr. Charles has received research support from Aeon. The institution of Dr. Charles has received research support from Impax. The institution of Dr. Charles has received research support from AskBio. The institution of Dr. Charles has received research support from BlueRock. The institution of Dr. Charles has received research support from AbbVie. The institution of Dr. Charles has received research support from Ipsen.
Maria Pia Sormani (University of Genoa)	Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol meyer. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Immunic. Maria Pia Sormani has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis, Roche. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche.

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