China Medical University Hospital is set to investigate an innovative approach to address behavioral and psychological symptoms of dementia. A newly announced clinical trial will explore the effects of laser acupuncture using an 808 nm laser pen, with comparisons against a sham procedure. Professionals working in clinical, regulatory, and medical device fields should take note of this development.
What changed?
A clinical trial titled “Laser Acupuncture for Behavioral and Psychological Symptoms of Dementia” has been announced, focusing on the application of medical devices to alleviate dementia-related symptoms. Not yet recruiting, this trial promises to investigate whether laser acupuncture can deliver measurable benefits over sham treatment methods.
What are the study details?
Who is conducting the study?
The trial is sponsored by China Medical University Hospital, a prominent research institution known for its focus on advanced therapeutic modalities.
What interventions will be tested?
Two test groups will be established:
- Laser Acupuncture: Participants in this group will undergo treatment using an 808 nm laser pen.
- Sham Laser Acupuncture: A placebo device will be used here to gauge the effectiveness of the actual intervention under controlled conditions.
What conditions are addressed?
The study targets two closely associated conditions:
- Behavioral and Psychological Symptoms of Dementia (BPSD)
- Dementia itself
What could be the potential impact?
The trial seeks to provide evidence on the applicability of laser acupuncture as a non-invasive intervention for managing symptoms of dementia. Behavioral and psychological symptoms such as agitation, depression, and anxiety significantly affect care requirements and the quality of life for patients and their families. If proven effective, this device could become an important tool in therapeutic strategies.
This study could have regulatory implications for evaluating similar devices under clinical performance and safety standards as outlined in MDR Annex XIV. Stakeholders in regulatory affairs and medical device compliance will find this development worth tracking.
FAQ
1. What types of devices are being tested?
Two device types are involved: the active 808 nm laser pen used for laser acupuncture and a placebo sham device.
2. When will recruitment begin?
The study is currently listed as “Not yet recruiting.” No specific start date has been announced.
3. How does laser acupuncture differ from traditional acupuncture?
Laser acupuncture uses focused laser energy to stimulate acupuncture points instead of needles, offering a potential non-invasive alternative.
Conclusion
The announcement of this trial underscores the growing interest in exploring advanced medical devices for managing challenging symptoms of dementia. Clinicians and regulatory teams should monitor its progress to better understand the implications for patient care pathways and device certification frameworks.
Disclaimer
This article is for informational purposes only and should not be considered legal advice. Regulatory professionals must ensure compliance based on specific jurisdictional requirements.
Announcement link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07204145?term=medical+device