Medtronic has released preliminary findings from the ADAPT-PD trial, which is evaluating its adaptive deep brain stimulation (aDBS) device, the Percept PC neurostimulator, in patients with Parkinson’s disease. The trial aims to demonstrate the safety and effectiveness of aDBS for managing Parkinson’s symptoms, with data intended to support global regulatory filings for the device.
The ADAPT-PD trial (NCT04547712) compares aDBS to continuous DBS (cDBS) in improving motor symptoms such as tremors, bradykinesia, and rigidity. Unlike cDBS, which delivers constant stimulation, aDBS provides personalized therapy by adjusting stimulation based on a patient's brain state. This approach aims to provide more stable symptom control while minimizing side effects and optimizing medication use.
The trial enrolled 68 participants implanted with either subthalamic nucleus (STN) or globus pallidus internus (GPi) DBS connected to a Percept PC neurostimulator. The study, initiated in 2021, assesses aDBS in real-world, 'at-home' settings. The primary endpoint focuses on the change in hours of 'On' time without troublesome dyskinesias, as reported in patient diaries, comparing aDBS to standard cDBS.
Local Field Potential Insights
The study also examined local field potential (LFP) signals, which are crucial for aDBS programming. Results indicated that an LFP signal sufficient for aDBS programming was present in 84% of patients, regardless of their Parkinson’s disease clinical subtype, with similar detection rates between STN and GPi targets. Medication status had a relatively small impact, with a 6.7% higher detection rate observed when patients were off medication.
Market Projections
According to GlobalData market analysis, the global market for neuromodulation devices was valued at approximately $6.06 billion in 2023 and is projected to exceed $8.9 billion by 2027. The deep brain stimulation device market segment is expected to reach $1.9 billion by 2030, reflecting the growing demand for advanced neuromodulation therapies.
Broader Neuromodulation Landscape
While initially developed for depression, neuromodulation devices are now being explored for various neurological disorders. Recent examples include Neurovalens’ Modius Sleep device receiving FDA clearance for chronic insomnia and Salvia BioElectronics' implantable neurostimulation system for severe migraine and cluster headaches. Additionally, Nexalin is investigating DBS for Alzheimer’s disease and dementia, and has reported positive data on neurostimulation for combat-related mild traumatic brain injury (mTBI) in veteran patients.
