Adaptive DBS Algorithm for Personalized Therapy in Parkinson’s Disease: ADAPT-PD clinical trial methodology and early data (P1-11.002)

Abstract

<h3>Objective:</h3> To describe the design and early data from the pivotal Adaptive DBS Algorithm for Personalized Therapy in Parkinson’s Disease (ADAPT-PD) clinical trial (NCT04547712). <h3>Background:</h3> In pilot studies, adaptive deep brain stimulation (aDBS) has been associated with greater motor symptom control, fewer side effects, and lower total electrical energy delivered (TEED) compared to continuous DBS (cDBS). <h3>Design/Methods:</h3> The ADAPT-PD study is a multicenter, prospective, single-blind, randomized crossover clinical investigation evaluating the safety and effectiveness of aDBS for Parkinson’s disease (PD). The study includes a cohort without (primary cohort) and with directional stimulation (directional cohort). Participants have globus pallidus pars interna or subthalamic nucleus DBS leads connected to a Medtronic PerceptTM PC DBS device capable of sensing local field potentials (LFPs). An investigational feature is unlocked to allow programming of two different aDBS modes using low frequency (8–30 Hz) LFP control signals. The study consists of four phases following enrollment: cDBS Baseline, aDBS Setup and Adjustment, aDBS Evaluation, and Long-term Follow-up. Randomized, single-blinded crossover to aDBS in a single or dual-threshold mode is executed in participants with an acceptable response to either or both aDBS modes. <h3>Results:</h3> The clinical trial is ongoing with 12 centers activated and 10 sites which have enrolled a primary cohort of 68 and a directional cohort of 17. Demographic and preliminary data will be featured at the time of presentation. Primary endpoint is the equivalence of aDBS to cDBS for ON time without troublesome dyskinesia. Other endpoints are TEED, motor assessments from a wearable device, Voice Handicap Index, MDS-UPDRS, EQ-5D-5L, PDSS-2, PDQ-39, and patient preference. Safety measures include stimulation-related adverse events (AEs), other AEs, and device deficiencies. <h3>Conclusions:</h3> This pivotal clinical study of aDBS in a clinical and home setting is expected to generate data to assess the safety and effectiveness for aDBS in PD. <b>Disclosure:</b> Dr. Bronte-Stewart has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medtronic Inc. Dr. Beudel has nothing to disclose. Dr. Ostrem has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbott. Dr. Ostrem has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Acadia. Dr. Ostrem has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Jazz . Dr. Ostrem has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Superness. Dr. Ostrem has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for AcureX. Dr. Ostrem has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Movement Disorders. The institution of Dr. Ostrem has received research support from Neuroderm. The institution of Dr. Ostrem has received research support from Boston Scientific. The institution of Dr. Ostrem has received research support from Medtronic. The institution of Dr. Ostrem has received research support from Rune. Dr. Fasano has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbott. Dr. Fasano has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Fasano has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ipsen. Dr. Fasano has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Medtronic. Dr. Fasano has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Boston Scientific. Dr. Fasano has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbott. Dr. Fasano has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medtronic. Dr. Fasano has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sunovion. Dr. Fasano has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Ceregate. The institution of Dr. Fasano has received research support from Boston Scientific. The institution of Dr. Fasano has received research support from Medtronic. The institution of Dr. Fasano has received research support from Abbvie. Dr. Fasano has received publishing royalties from a publication relating to health care. Leonardo Almeida has nothing to disclose. Travis Hassell has nothing to disclose. Dr. Moro has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Medtronic, Abbott, Kyowa. Dr. Moro has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Springer. The institution of Dr. Moro has received research support from Abbott. The institution of Dr. Moro has received research support from IPSEN. The institution of Dr. Gostkowski has received research support from Medtronic. Dr. Mitchell has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boston Scientific. The institution of Dr. Mitchell has received research support from Medtronic. The institution of Dr. Mitchell has received research support from Deep Brain Innovations. The institution of Dr. Mitchell has received research support from National Institutes of Health. The institution of Dr. Mitchell has received research support from National Institute on Aging. Dr. Hainque has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boston Scientific. Dr. Hainque has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Medtronic. Dr. Sarangmat has nothing to disclose. Scott Stanslaski has received personal compensation for serving as an employee of Medtronic. Scott Stanslaski has received stock or an ownership interest from Medtronic. Scott Stanslaski has received intellectual property interests from a discovery or technology relating to health care. Lisa Tonder has received personal compensation for serving as an employee of Medtronic. An immediate family member of Lisa Tonder has received personal compensation for serving as an employee of Medtronic. Rebekah Summers has received personal compensation for serving as an employee of Medtronic. Rebekah Summers has received research support from National Institute of Health. Dr. Raike has received personal compensation for serving as an employee of Medtronic. Dr. Raike has received intellectual property interests from a discovery or technology relating to health care. Dr. Herrington has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medtronic, Inc. Dr. Herrington has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MarvelBiome. Dr. Herrington has received personal compensation in the range of $0-$499 for serving as an Expert Witness for CRICO. The institution of Dr. Herrington has received research support from NIH/NINDS (K23NS099380).

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