The ADAPT-PD trial will evaluate the safety and efficacy of aDBS therapy in patients with Parkinson's disease
Medical technology company Medtronic has begun the trial of its adaptive deep brain stimulation (aDBS) therapy with Parkinson’s disease (PD) patients.
The company has announced the first recruitment in ADAPT-PD (adaptive DBS algorithm for personalised therapy in Parkinson’s disease) trial to assess the safety and efficacy of aDBS therapy in PD patients.
According to the company, aDBS is an investigational feature of the Percept PC device (cDBS) that could be enabled if approved.
The investigational feature used in the trial enables automated adjustment of brain stimulation to deliver therapy to manage symptoms of Parkinson’s disease based on a patient’s clinical state.
Medtronic to conduct study across 12 sites
Medtronic is set to conduct the randomised study across 12 sites at Movement Disorders research centres in the US, Europe and Canada. The company will assess up to 36 subjects with a total evaluation period of 15 months.
The trial’s primary endpoint will compare standard continuous DBS (cDBS) to aDBS for hours of on time without troublesome dyskinesia.
Qualifying subjects in the trial will secure cDBS at baseline followed by randomised evaluation of two different aDBS algorithms in a blinded manner.
DBS is said to be a safe and effective therapy to treat motor symptoms in PD, including tremor (shaking), slowed movement (bradykinesia), and stiffness (rigidity).
The cDBS uses BrainSense technology, thereby enabling to make it the only DBS system with the potential to capture patient-specific brain signals.
Medtronic restorative therapies group’s brain modulation business general manager and vice president Mike Daly said: “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.”
“Additionally, stimulation adjusted based on patient need, aDBS, could reduce total power output and possibly extend the life of the device.”
In November 2020, Medtronic closed the acquisition of France-based spinal surgery technology firm Medicrea International.