A new clinical trial is set to explore the impact of spinal cord stimulation (SCS) on orthostatic hypotension (OH) in individuals affected by Parkinsonism. The study, sponsored by Ruijin Hospital, aims to investigate the safety, efficacy, and mechanisms underlying the use of two types of SCS devices. This trial remains in the “Not yet recruiting” phase as of January 2026.
In this article:
- What changed?
- How does spinal cord stimulation work?
- Why focus on Parkinsonism and OH?
- What are the study details?
- FAQ
- Conclusion
- Disclaimer
- More information
What changed?
Orthostatic hypotension is a significant challenge for those living with Parkinsonism, often exacerbating symptoms and reducing quality of life. Spinal cord stimulation, a medical device intervention, is emerging as a potential therapeutic option. This study from Ruijin Hospital emphasizes the growing interest in device-based solutions to address autonomic dysfunctions in neurological diseases. It is the focus on device safety and clinical performance that sets this investigation apart.
How does spinal cord stimulation work?
Spinal cord stimulation involves the application of electrical impulses to specific regions of the spinal cord. These devices, including both epidural and transcutaneous models used in this study, aim to modulate nerve activity. By targeting neural pathways, SCS may help stabilize the blood pressure fluctuations characteristic of OH in patients with Parkinson’s disease.
Types of spinal cord devices being tested
The trial compares two different SCS devices:
- Epidural spinal cord stimulation: Invasive procedure where electrodes are implanted near the spinal cord.
- Transcutaneous spinal cord stimulation: Non-invasive device applying electrical stimulation through the skin.
Each device type will undergo rigorous evaluation, including efficacy and ease of use.
Why focus on Parkinsonism and OH?
Parkinsonism encompasses a range of neurodegenerative conditions, including Parkinson’s disease, that impair motor and non-motor functions. Orthostatic hypotension—a sudden drop in blood pressure when standing—complicates disease management. There is a pressing need to develop interventions capable of improving blood pressure stability while minimizing adverse effects. This study’s targeted approach hopes to uncover whether SCS offers measurable benefits with manageable risks.
What are the study details?
The trial, sponsored by Ruijin Hospital, will evaluate the two devices in participants diagnosed with Parkinsonism and experiencing OH. This “Not yet recruiting” study will involve safety monitoring, device performance assessments, and investigations into mechanisms of action. Although recruitment timelines are not yet confirmed, potential participants and clinical stakeholders should monitor developments closely.
Clinical focus
The study emphasizes clinical endpoints tied to functional improvements, including:
- Blood pressure regulation upon standing.
- Reduction of symptoms related to OH.
- Patient-reported quality of life enhancements.
Such findings may directly inform regulatory frameworks and healthcare practices surrounding medical devices for neurological indications.
FAQ
1. What is spinal cord stimulation (SCS)?
SCS is a therapy using electrical impulses to influence nerve activity, primarily targeting pain relief or functional regulation in conditions such as Parkinsonism.
2. Why is the focus on orthostatic hypotension?
OH is a debilitating condition for many Parkinsonism patients, causing significant symptoms and reduced quality of life. New interventions are urgently needed.
3. What is the current status of this trial?
The study is in the “Not yet recruiting” stage as of January 2026.
4. Who is conducting this study?
The trial is sponsored by Ruijin Hospital, showcasing its investment in innovative medical device research.
Conclusion
The investigation into spinal cord stimulation for orthostatic hypotension in Parkinsonism represents a promising frontier in medical device innovation. Both clinicians and regulatory professionals should track the trial’s progress to assess its potential to transform care delivery in neurological diseases.
Disclaimer
This content is for informational purposes only. It does not constitute legal, medical, or regulatory advice. Please consult official sources or professionals for guidance.
More information
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07322458?term=medical+device