An upcoming pilot study promises to shed light on the therapeutic use of magnetic resonance imaging-guided repetitive transcranial magnetic stimulation (rTMS) in adolescents with depression. The research, sponsored by the First Affiliated Hospital of Chongqing Medical University, aims to evaluate both efficacy and safety. Currently listed as “not yet recruiting,” this study may be of key interest to clinical, quality, and regulatory professionals monitoring advancements in medical devices.
What is the objective of the study?
The pilot study will explore the use of MRI-guided rTMS in adolescents aged 12 to 18 diagnosed with major depressive disorder. This double-blind and randomized design ensures scientific rigor. Its primary focus is to evaluate the treatment’s precision and safety while investigating its therapeutic outcomes.
What treatments will be evaluated?
The study will test three groups:
- Experimental Targeted rTMS: Utilizing magnetic resonance imaging to enhance targeting accuracy.
- Conventional Targeted rTMS: Standard rTMS approaches without MRI enhancement.
- Sham Stimulation: A placebo approach for comparison.
These groups were chosen to determine the effectiveness of MRI-guided enhancements in therapy delivery.
Who is the study targeting?
Adolescents diagnosed with major depressive disorder are the primary participants. This specific focus highlights the critical gap in young patient data for innovative depression treatments. The outcomes could provide age-specific insights into device safety and clinical applicability.
FAQs
1. What is rTMS?
Repetitive Transcranial Magnetic Stimulation is a non-invasive procedure using magnetic pulses to stimulate brain regions. It is often explored as an alternative therapy for depression.
2. Why is MRI guidance considered valuable?
MRI allows for improved targeting of brain regions, potentially increasing treatment effectiveness and reducing unintended side effects.
3. When will recruitment begin?
The study is currently marked as “not yet recruiting.” No further details on timelines were provided.
Conclusion
The findings of this study could offer regulatory groups and clinical teams important insights into device optimization and indications for adolescent mental health treatment. Professionals should monitor this study to evaluate potential performance trends. As innovative trials like this develop, real-world impacts on depression solution pathways could change dramatically.
Disclaimer
This article is intended for informational purposes. It does not constitute regulatory, clinical, or legal advice.
Announcement and link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07185438?term=medical+device