Abstract Details

Title Directional versus omnidirectional Deep Brain Stimulation: Results of a Multi-Center Prospective Blinded Crossover Study

Topic Movement Disorders

Presentation(s) S55 - Movement Disorders: Neuromodulation, Circuits, and Management (5:06 PM-5:18 PM)

Poster/Presentation
Number 009

Objective

To compare the range of stimulation amplitudes that can relieve symptoms without side effects, between directional and omnidirectional DBS

Background Recently introduced directional DBS leads are capable of axially asymmetric field restriction. Therapeutic window (TW) has been introduced in DBS to describe the range of stimulation amplitudes achieving symptom relief without side effects. The PROGRESS study evaluated whether directional DBS provides a wider TW in a large prospective trial

Design/Methods Participants receiving subthalamic nucleus DBS for Parkinson’s disease were programmed with omnidirectional stimulation for 3 months, followed by directional stimulation for another 3 months. The subject was blinded to all details of stimulation, and a blinded evaluator assessed TW and motor symptoms. The primary endpoint was based on blinded off-medication evaluation of TW for directional vs. conventional stimulation at the 3-month follow-up. Additional endpoints at 3-, 6- and 12-month follow-ups included adverse events, subject and clinician stimulation preference and UPDRS part III motor score

Results A directional DBS system was implanted in 234 subjects (62±8 years, 33% female). No intracranial hemorrhages or infections occurred. TW was wider using directional stimulation in 90.6% of subjects, satisfying the primary endpoint for superiority (p<0.001). The mean increase in TW with directional stimulation was 41% (2.98±1.38mA, compared to 2.11±1.33mA for omnidirectional, p<0.001). UPDRS part III motor score on medication was improved with either stimulation at each time point (p<0.001). After 6 months, 53% of subjects blinded to stimulation type (102/193) preferred the period with directional stimulation, 26% (50/193) preferred the omnidirectional period and 21% (41/193) had no preference. The directional period was preferred by 59% of clinicians (113/193) vs. 21% (41/193) who preferred the omnidirectional period

Conclusions In this international prospective blinded crossover study, directional stimulation yielded a wider TW compared to omnidirectional stimulation and was preferred by subjects blinded to stimulation type

Authors/Disclosures
Leonard Verhagen Metman, MD, PhD (Northwestern University) PRESENTER	Dr. Verhagen Metman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AbbVie. Dr. Verhagen Metman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbott. Dr. Verhagen Metman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Mitsubishi Tanabe. Dr. Verhagen Metman has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Supernus. Dr. Verhagen Metman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for AbbVie. Dr. Verhagen Metman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Cerevel. Dr. Verhagen Metman has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Frontiers.
	No disclosure on file
Pablo Mir, MD (Servicio De Neurologia. Hospital Virgen Del Rocio)	No disclosure on file
Matthew A. Brodsky, MD	Dr. Brodsky has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Medtronic. The institution of Dr. Brodsky has received research support from Boston Scientific.
	No disclosure on file
	No disclosure on file
Andrew H. Evans, MB, BS	Mr. Evans has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for AbbVie. Mr. Evans has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Stada. Mr. Evans has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Seqirus. Mr. Evans has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Ipsen. Mr. Evans has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for AbbVie. Mr. Evans has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Stada. The institution of Mr. Evans has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Ipsen. Mr. Evans has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Seqirus.
Marta Blazquez Estrada	Marta Blazquez Estrada has nothing to disclose.
	No disclosure on file
	No disclosure on file
Julie Pilitsis	Julie Pilitsis has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbott. Julie Pilitsis has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Aim Medical Robotics . Julie Pilitsis has stock in Aim Medical Robotics . The institution of Julie Pilitsis has received research support from Medtronic. The institution of Julie Pilitsis has received research support from Boston Scientific. The institution of Julie Pilitsis has received research support from Abbott. The institution of Julie Pilitsis has received research support from Focused Ultrasound Foundation. The institution of Julie Pilitsis has received research support from NIH 2R01CA166379. The institution of Julie Pilitsis has received research support from NIH R01EB030324. The institution of Julie Pilitsis has received research support from NIH-NeuroBlueprint MedTech 5U54EB033650.
	No disclosure on file
Winona W. Tse, MD (Mount sinai medical center)	Dr. Tse has nothing to disclose.
Leonardo Almeida (University of Florida College of Medicine - Neurology)	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
Edward Karst	Edward Karst has received personal compensation for serving as an employee of Synchron. Edward Karst has received personal compensation for serving as an employee of Abbott.
	No disclosure on file
	No disclosure on file

��ɫ��

��ɫ��