As of February 15 2026 at 14 09 UTC a not yet recruiting study led by the University of Florida and supported by Boston Scientific Corporation is evaluating the safety and tolerability of patterned stimulation for deep brain stimulation in Parkinson disease. The trial lists several stimulation configurations for assessment in a home setting, including biphasic deep brain stimulation, conventional deep brain stimulation, theta burst deep brain stimulation, and multi frequency deep brain stimulation. The official ClinicalTrials.gov registry provides the scope and sponsors for this device oriented evaluation and points to the record NCT07410598 for reference.
What changed in home based patterned stimulation for Parkinson disease
The record signals a focus on home based assessment of patterned stimulation in people who use deep brain stimulation. The description enumerates four stimulation configurations to be evaluated in a home context and notes the study status as not yet recruiting. These configurations include biphasic patterns, conventional DBS, theta burst DBS and multi frequency DBS. The aim is to observe practical usability and performance differences across configurations while maintaining device oriented oversight.
How the trial is designed
Key design elements emphasize safety and tolerability in a home context. The four device configurations are biphasic deep brain stimulation, conventional deep brain stimulation, theta burst deep brain stimulation, and multi frequency deep brain stimulation. The study is sponsored by the University of Florida and Boston Scientific Corporation. Because the trial status is not yet recruiting, investigators are preparing protocols, training materials and remote monitoring plans before enrollment begins. The design aligns with a device oriented evaluation that may require enhanced risk management and caregiver education for home use.
What devices are studied
The study references device based deep brain stimulation approaches rather than a single therapy. Biphasic patterns refer to balanced stimulation phases that alternate polarity. Conventional deep brain stimulation describes standard fixed or programmable pulsed current. Theta burst deep brain stimulation uses high frequency bursts delivered in short trains. Multi frequency deep brain stimulation combines multiple stimulation rates in a single session. The comparison among these modes aims to illuminate practical considerations for home based care and ongoing device management.
What safety measures are described
Safety and tolerability assessments include predefined criteria for adverse events, device performance checks and patient education about device use in a home environment. The registry does not publish results yet but the emphasis on home use increases the importance of remote monitoring capabilities and care coordination. Sponsors may implement risk controls and data reporting plans consistent with regulatory expectations for class two medical devices used in a home setting.
What regulatory implications exist for home based DBS use
From a regulatory perspective the record focuses on intended purpose and device performance under conditions outside traditional clinical environments. It highlights the responsibility of the sponsor to demonstrate safety and tolerability for the four stimulation patterns in people with Parkinson disease using implanted systems. The MDR style framing requires clear statements about the device expected performance and limitations, with manufacturer statements marked as such. Because the trial is not yet recruiting the period before enrollment allows broader risk management planning and post market surveillance considerations. The sponsor and study design must align with regulatory expectations for home use of neuromodulation devices and ensure training remote monitoring and escalation pathways are documented prior to any patient contact.
Where to find more information
Official information is available on the ClinicalTrials.gov registry. The record NCT07410598 provides the scope interventions and sponsor details for this home based patterned stimulation study. Researchers and professionals may review the registry to understand planned protocol elements and status. The page serves as the primary source for updates and clarifications as the study progresses.
- 1. What is the purpose of this trial The trial seeks to assess safety and tolerability of patterned stimulation for deep brain stimulation in the home setting for people with Parkinson disease.
- 2. Which devices are examined The study lists four stimulation patterns including biphasic conventional theta burst and multi frequency deep brain stimulation as device oriented interventions.
- 3. What is the enrollment status The record shows not yet recruiting which means screening and enrollment have not begun.
Conclusion and implications for practice
This regulatory oriented update summarizes a not yet recruiting study that may influence future device labeling patient education and home care practices. Readers should monitor the ClinicalTrials.gov page for official status and any protocol changes. The information helps planners and regulators anticipate how home based patterned stimulation could be evaluated in real world settings.
Disclaimer professionals readers should note this article does not constitute legal or regulatory advice. It is for informational purposes based on the public trial record. Always consult official guidance and the device manufacturer for regulatory obligations.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07410598?term=medical+device