The University of California, Los Angeles (UCLA) is currently recruiting participants for a groundbreaking clinical trial aimed at exploring the effectiveness of repetitive Transcranial Magnetic Stimulation (rTMS) for treating Borderline Personality Disorder (BPD). This device-focused research initiative marks a significant step toward expanding therapeutic options for patients grappling with this complex condition. Regulatory, clinical, and quality teams may find this investigation particularly relevant due to its implications for medical device innovation and compliance pathways.
What is this trial about?
This clinical trial centers on the use of repetitive Transcranial Magnetic Stimulation (rTMS), a non-invasive medical device technology, to address symptoms of Borderline Personality Disorder. Sponsored by UCLA, the study aims to evaluate the device’s safety, performance, and intended therapeutic benefits in a structured clinical setting. Research findings may provide new insights into personalized interventions for patients, aligning with advancements in psychiatric device innovation.
Why is a device being tested?
Borderline Personality Disorder is often treated with psychotherapy or medication. However, these approaches do not consistently yield effective outcomes for all patients. Devices like rTMS offer an alternative, utilizing magnetic fields to stimulate specific brain regions involved in mood regulation and emotional processing. The trial is based on evidence suggesting rTMS may reduce the severity of BPD symptoms.
From a regulatory perspective, evaluating devices like rTMS ensures compliance with safety and efficacy thresholds established under medical device regulations, including MDR and FDA frameworks. This study provides a pathway for the evolving use of device-based therapies in psychiatry.
Who qualifies as a participant?
The study is actively recruiting individuals diagnosed with Borderline Personality Disorder or related conditions. Interested participants must meet defined eligibility criteria to ensure that data collected contribute to valid and reliable outcomes. For full inclusion and exclusion criteria, patients or healthcare providers are encouraged to consult directly with the research team through the trial link.
Frequently Asked Questions
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What makes rTMS different from traditional therapies?
rTMS uses targeted magnetic stimulation rather than pharmacological or psychotherapy-based methods, offering a non-invasive alternative. -
Is this trial FDA-approved?
While specific regulatory approvals for devices like rTMS depend on their marketed use, the UCLA trial complies with ClinicalTrials.gov requirements tied to U.S. regulatory standards. -
How can interested participants enroll?
Eligible individuals can enroll via the clinical trial contact information provided in the source link.
Conclusion and implications
UCLA’s exploration of rTMS for Borderline Personality Disorder highlights medical device innovation’s role in expanding psychiatric therapy options. Clinical teams, regulatory professionals, and device developers may find this trial highly relevant due to its potential to influence future market pathways and therapeutic standards.
Important disclaimer
This article is designed for informational purposes only and does not constitute legal advice. Readers seeking regulatory guidance should consult legal or compliance experts familiar with medical device laws.
Source and announcement link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07197502?term=medical+device