A new clinical trial exploring the comparative effects of deep brain stimulation (DBS) at the Subthalamic Nucleus (STN) and Globus Pallidus Internus (GPi) in Parkinson’s disease treatment has been announced. Sponsored by Zhang Jianguo, the trial is set to investigate three DBS strategies. Clinical and regulatory teams should note that this study is not yet recruiting as of November 26, 2025.
What changed?
The trial, titled “Subthalamic Nucleus Versus Globus Pallidal Internus Deep Brain Stimulation for Parkinson Disease,” will examine whether targeting STN or GPi regions—or using both—offers superior clinical outcomes in Parkinson’s disease patients requiring DBS therapy. Currently, this study is listed as “not yet recruiting,” meaning participants are not being enrolled at this time. Investigators and stakeholders in medical devices and neurology should monitor updates on the recruitment status.
What are the study details?
Scope and Purpose
This trial aims to address critical questions about the efficacy and safety of deep brain stimulation therapies in neurological disorders. Specifically, the study evaluates three intervention methods:
- STN-DBS stimulation
- GPi-DBS stimulation
- Combined STN and GPi stimulation
Parkinson’s disease (PD) remains a progressive neurodegenerative disorder with tremor, rigidity, and bradykinesia as its hallmarks. While DBS has been a key treatment modality for advanced PD, determining the optimal stimulation site can enhance patient outcomes and guide future device development.
Sponsored by Zhang Jianguo
The trial is sponsored by Zhang Jianguo, whose role involves ensuring proper execution and regulatory compliance throughout the study period. Details associated with the manufacturer of DBS devices and collaborating institutions were not explicitly listed.
Regulatory Context
The study operates under the guidance of clinical trial standards ensuring compliance with medical device regulatory frameworks, especially regarding safety and performance testing. Researchers and the broader healthcare community are encouraged to follow developments as this trial progresses.
How might this impact patients?
In terms of patient care, better understanding the comparative impacts of STN and GPi stimulation—or their combination—may refine standards for Parkinson’s disease management. Clinicians might gain insights into which stimulation method delivers the best functional outcomes for motor symptoms, quality of life, and adverse effects. If successful, findings could influence both regulatory pathways and clinical guidelines for advanced PD interventions.
Frequently Asked Questions
1. What devices are being used in this trial?
Three stimulation approaches will be evaluated: STN-DBS, GPi-DBS, and combined STN/GPi-DBS. Exact device manufacturers were not specified.
2. When will the trial begin recruitment?
As of November 26, 2025, the trial is listed as “not yet recruiting.” Further updates may clarify recruitment timelines.
3. What is the trial’s main objective?
The study aims to compare outcomes and safety profiles between different DBS target sites in treating Parkinson’s disease.
Conclusion & Implications
For clinicians and stakeholders in neurology and medical devices, this trial underscores the ongoing pursuit of precision medicine in Parkinson’s disease care. Monitoring upcoming developments in this trial may provide actionable data to refine regulatory pathways or inform clinical practice. Interested parties should stay updated on further announcements regarding recruitment phases and preliminary results.
Disclaimer
This information is provided for regulatory and informational purposes only. It does not constitute medical or legal advice. Always consult official sources for guidance.
Full Announcement & Link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07250685?term=medical+device