Abstract Details

Continuous DBS (cDBS) therapy for PD plus medication is standard of care but may lead to over or under-treatment.

Demonstrate the safety and effectiveness of chronic adaptive deep brain stimulation (aDBS) in Parkinson’s disease (PD).

The ADAPT-PD Trial (NCT04547712) is a multicenter, prospective, single-blind, randomized crossover pivotal trial of at-home aDBS in patients with PD. Participants entered the study with globus pallidus internus or subthalamic nucleus DBS and a sensing-enabled Medtronic Percept^TM PC DBS device. Investigational software unlocked two aDBS modes (single threshold [ST] or dual threshold [DT]) driven by local field potential power (8-30 Hz range). Participants were randomized to 30 days of one mode, then crossed over to 30 days of the other mode if feasible. Participants chose the mode of DBS (ST aDBS, DT aDBS, cDBS) during the long-term follow-up phase.

68 participants enrolled (71% male, 62.2±8.4 years old, 13.5±6.8 years disease duration). At least one aDBS mode was feasible in 45/52, and 30 tolerated both modes. The primary outcome was achieved: participants had similar “On” time without troublesome dyskinesia during aDBS compared to cDBS (% similar “On” time to cDBS: ST 92%, DT 95%, both P < 0.001). Average “On” time improved with aDBS compared to cDBS of 0.6±3.6 hours with ST and 1.4±3.0 hours with DT; DT improvement was statistically significant and clinically meaningful (97.5% confidence limit 0.2 to 2.5, p<0.0125)^1-2. TEED trended lower during aDBS (median -13% ST, -11% DT). Similar adverse event rates were observed between aDBS modes with no serious adverse device events (SADEs). 44/45 participants chose to continue on aDBS in long-term follow-up (17 ST and 27 DT).

Chronic aDBS for PD achieved the primary outcome; DT aDBS provided statistically significant improved “On” time compared to cDBS. There were no SADEs and 98% of participants chose to remain on aDBS.