A new clinical trial is set to explore the impact of neurofeedback technology on individuals with co-occurring obsessive compulsive disorder (OCD) and post-traumatic stress symptoms (PTSS). Sponsored by Wayne State University, this study aims to assess the device Neuroptimal (Zengar, Inc.), which is designed to enhance psychological well-being through advanced neurofeedback methodologies. The research is not yet recruiting but presents significant implications for mental health therapeutic advancements.
What is the study about?
This upcoming clinical trial, registered under ClinicalTrials.gov (NCT07217925), seeks to determine the effects of the Neuroptimal neurofeedback device on patients who simultaneously experience OCD and PTSS. The primary goal is to evaluate whether the device can improve psychological well-being, mood regulation, and emotional stability while decreasing dissociation for affected individuals. Researchers aim to provide validated evidence for its safety and performance as per US regulatory requirements.
How does Neuroptimal work?
Neuroptimal, produced by Zengar, Inc., is a neurofeedback device that monitors brain activity and provides real-time feedback to users through auditory or visual signals. These signals are designed to encourage self-regulation of cognitive patterns, potentially optimizing emotional and psychological resilience. The device does not require specific cognitive efforts from users during sessions, making it accessible for individuals with varied conditions.
Who is part of the target group?
The trial focuses on individuals diagnosed with both OCD and PTSS. These co-occurring conditions can severely impair emotional regulation, mood stability, and overall well-being. By targeting this specific population, researchers plan to assess the device’s suitability for complex psychological disorders where traditional therapies may fall short.
Frequently Asked Questions
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1. What is neurofeedback?
Neurofeedback is a therapeutic technique that uses real-time monitoring of brain activity to promote self-regulation. It typically involves sensors detecting brainwaves, which are then translated into audiovisual signals that guide users. -
2. Why combine OCD and PTSS in one study?
Many individuals with OCD also experience symptoms of PTSS, as both conditions can be interconnected through patterns of cognitive and emotional dysregulation. Studying them together can uncover shared therapeutic approaches. -
3. Is the Neuroptimal device FDA approved?
The study does not explicitly mention FDA approval. Consult the device manufacturer or awaiting trial results may clarify its standing. -
4. When is recruitment starting?
Recruitment details have not yet been announced. Updates may be available through ClinicalTrials.gov or Wayne State University’s communication channels.
Key takeaways
This clinical trial marks an important step in understanding and addressing co-occurring OCD and PTSS through the application of neurofeedback technology. If successful, it may pave the way for more accessible, non-invasive treatment options, offering relief to patients facing significant mental health challenges. Stakeholders in clinical research, regulatory affairs, and medical device innovation will find this trial worth following closely.
Disclaimer
The information provided here is for professional reference only and does not constitute legal or regulatory advice. For official details, readers should refer to the trial documentation or consult industry experts.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07217925?term=medical+device