ADAPT-PD Trial Announced for Adaptive Deep Brain Stimulation in Parkinson Disease

Author(s):

If approved, adaptive DBS could be added to Medtronic’s Percept device, which was approved in June 2020.

Andrea Kühn, Prof. Dr. Med

Medtronic has announced ADAPT-PD (Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease) trial to evaluate the safety and efficacy of adaptive deep brain stimulation (aDBS) in patients with Parkinson disease (PD).¹

The randomized study will be investigated at 12 study sites at movement disorders research centers in the US, Europe, and Canada. The trial expects to enroll 36 subjects for a 15-month evaluation.

Andrea Kühn, Prof. Dr. Med., professor and head, movement disorders and neuromodulation, Charité University Hospital, Berlin, said in a statement that "aDBS technology will allow DBS to be responsive in real-time, communicating with the patient's brain, as needed—which could reduce the amount of programming burden on a clinician."

The primary endpoint will be the comparison of aDBS to standard continuous DBS for hours of ‘On’ time without troublesome dyskinesias, efficacy, and adverse effects by patient reports. Subjects till receive cDBS at baseline followed by 1 of 2 blinded and randomized aDBS algorithms.

aDBS is an investigational feature of the Percept PC device approved in June 2020 for the treatment of Parkinson disease, essential tremor, dystonia, epilepsy, or obsessive-compulsive disorder.² Percept uses proprietary BrainSense technology to continuously capture and record brain signals while delivering therapy, the only such device of its kind.

Physicians using the Percept PC device can track those signals to then correlate them to their patient’s symptoms, adverse events (AEs), or medication intake. NeurologyLive has previously written about the approval of Percept; further information can be found by clicking here.

“There is nothing that can replace clinical judgement in treating patients. For the first time, this technology gives clinicians feedback directly from the DBS patient’s brain,” said Mike Daly, vice president and general manager, Brain Modulation, Restorative Therapies Group, Medtronic, in a statement concerning Percept’s approval. “With such data-driven, patient-specific insights, we believe it can change the standard of care.”

If approved, aDBS will be added to the Percept device and would allow for automated adjustment of DBS to provide therapy to manage symptoms of PD based on a patient's clinical state. DBS is a well-established, safe and efficacious therapy for the treatment of motor symptoms in PD such as bradykinesia, and rigidity. Current approved DBS systems employ cDBS and have to be manually adjusted.

"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," Daly said in the statement. "Additionally, stimulation adjusted based on patient need, aDBS, could reduce total power output and possibly extend the life of the device."

The foundation for ADAPT-PD was established after the first closed loop DBS studies in PD using the investigational prototype research-only system, Activa PC+S-Nexus.³ADAPT-PD differs from those early studies in that stimulation can be automatically adjusted while brain signals are monitored, allowing patients in the study to be both treated and measured while outside the clinic.

REFERENCES

1. Medtronic launches first-of-its-kind adaptive deep brain stimulation (aDBS) Trial in Parkinson's Disease patients. News release. Medtronic. January 14, 2021. Accessed January 26, 2021. https://www.prnewswire.com/news-releases/medtronic-launches-first-of-its-kind-adaptive-deep-brain-stimulation-adbs-trial-in-parkinsons-disease-patients-301207921.html
2. FDA approves first-of-its-kind Percept™ PC neurostimulator with BrainSense™ technology. News release. June 25, 2020. Accessed January 26, 2021. http://www.globenewswire.com/news-release/2020/06/25/2053361/0/en/FDA-Approves-First-Of-Its-Kind-Percept-PC-Neurostimulator-with-BrainSense-Technology.html
3. Velisar A, Syrkin-Nikolau J, Blumenfeld Z, et al. Dual Threshold neural closed loop deep brain stimulation in Parkinson disease patients. Brain Stimul. 2019: 12(4). doi: 10.1016/j.brs.2019.02.020