Adaptive Deep Brain Stimulation Study Launched for Individuals With Parkinson Disease
The ADAPT-PD study (NCT04547712) to evaluate automated adjustment of deep brain stimulation (aDBS) (Percept; Medtronic, Dublin, Ireland) for individuals with Parkinson disease (PD) has begun enrollment. The automated adjustment is a change in stimulation in response to an individual’s brain activity measured by the stimulation device implanted in the person’s brain.
Dr. Helen Bronte-Stewart, the North American principal investigator for the ADAPT-PD study, enrolled the first participant at the Stanford Movement Disorders Center. The ADAPT-PD study builds on Dr. Bronte-Stewart and collaborators' work with an investigational prototype research-only system in a closed loop deep brain stimulation study for individuals with PD.
The ADAPT-PD study will be using an investigational aDBS feature. Although the feature has yet to be approved, the device was approved by the Food and Drug Administration (FDA) in June 2020. The device (cDBS) utilizes proprietary technology making it the only DBS system with the ability to capture patient-specific brain signals. The sensing feature of the system is intended for use in participants receiving DBS for whom chronically recorded bioelectric data may provide useful, objective information. Planned enrollment is 36 participants who will be evaluated for 15 months. In the ADAPT-PD study, participants will report the duration of ‘ON’ time without troublesome dyskinesias with standard continuous DBS (cDBS) vs aDBS.
"Percept PC was developed with a significant amount of capabilities built into its system. We see this technology evolving to deliver even more value over time. The recently initiated ADAPT-PD is the first trial to gather clinical evidence to unlock those capabilities," said Mike Daly, vice president and general manager of the Brain Modulation business, which is reported as part of the Restorative Therapies Group at Medtronic. "Additionally, stimulation adjusted based on patient need, aDBS, could reduce total power output and possibly extend the life of the device."