Medtronic is offering a peek into its ongoing, at-home trial of people with Parkinson’s disease being treated with adaptive deep brain stimulation, a technology that’s currently under review at the FDA.
A paper on the methods being used in the company’s clinical study, named ADAPT-PD, was published this week in the Nature journal npj Parkinson’s Disease, exploring how treatment algorithms that react to the body’s brain activity may help improve the management of the neurodegenerative disease’s motor symptoms.
ADAPT-PD is a randomized crossover study that has enrolled 68 patients implanted with Medtronic’s Percept PC neurostimulator, to compare the fluctuating doses of adaptive brain stimulation, or aDBS, to continuous therapy. The medtech giant described the trial as the longest and largest to examine the approach in an everyday, real-world setting.
Medtronic previously received an FDA approval in 2021 for deep brain stimulation hardware that could sense and record changes in the brain’s neural activity, measured as local electric field potentials. That information could be used by clinicians to wirelessly program a patient’s implant and better tailor their therapy.
The company took a step closer to having its devices make those alterations on their own and in real-time, with U.S. and European green lights near the top of this year for its separate Percept RC rechargeable neurostimulator and its BrainSense technology—which also helps clinicians identify changes in brain signals alongside patient-recorded events like disease symptoms or drug side effects.
Both the RC and PC function similarly to a pacemaker, with a power generator placed in the chest that is wired to the brain with electrical leads. Medtronic said ADAPT-PD would help support global regulatory submissions for aDBS in people with Parkinson’s disease.
The adaptive approach is designed to track the activity in the brain’s globus pallidus internus or subthalamic nucleus—areas linked with the Parkinson’s disease symptoms that can be categorized as being in “on” or “off” periods during the course of a day.
The study said that identifiable local field potential signals, strong enough to be used for triggering therapy, were found in about 84% of patients—regardless of their Parkinson’s subtype—and they were largely not masked by medications.
By targeting neurostimulation timing and dose levels specifically during the “off” phase, when the effects of medication have diminished, researchers aim to minimize the need for medication while avoiding the dyskinesia side effects that can come when peak drug levels and DBS therapy overlap.
The researchers said the study’s results would also help lay the groundwork for adaptive approaches in other movement and neurological disorders.