A new clinical trial has been launched to assess the effectiveness of Transcranial Alternating Current Stimulation (tACS) as a treatment option for refractory constipation in individuals with Somatic Symptom Disorder. Sponsored by the Xijing Hospital of Digestive Diseases, the study seeks to provide evidence for this medical device’s therapeutic potential, especially for conditions resistant to conventional approaches.
This study is now actively recruiting participants and represents a promising avenue for multidisciplinary treatment approaches. Medical device manufacturers, clinicians, and regulatory professionals are encouraged to take note of this innovative investigation.
In this article
What is this clinical trial about?
The trial targets individuals suffering from Functional Constipation (FC) diagnosed alongside Somatic Symptom Disorder as defined by DSM-5 criteria. Previous treatments often fall short for these patients, creating a significant clinical need for alternative solutions. Transcranial Alternating Current Stimulation (tACS), a non-invasive brain stimulation device, is being tested alongside a placebo device to evaluate its therapeutic capabilities specifically in this context.
Somatic Symptom Disorder often complicates treatments by amplifying symptom perception, further underscoring the necessity for evidence-based and innovative approaches such as tACS.
How will the study be conducted?
The study employs a randomized, placebo-controlled design to ensure robust data collection and unbiased results. Participants will either receive active tACS sessions or placebo interventions to isolate the effects of the device. Researchers will monitor parameters including symptom relief, functional performance, and safety outcomes.
By adhering to rigorous clinical trial standards, the Xijing Hospital of Digestive Diseases aims to uphold regulatory standards while addressing patient-centric endpoints. Notably, this ensures data collected is sufficiently robust for potential regulatory review and subsequent clinical applications.
Who does this impact?
This trial has important implications for clinicians dealing with patients experiencing persistent functional constipation that has resisted conventional treatment methods. Additionally, medical device developers may look to this research as a case study of how tACS could be applied within other therapeutic areas.
Regulators and policymakers are also key stakeholders. The trial will likely generate critical evidence on safety, performance, and patient outcomes, which could significantly influence future medical device regulations and adoption rates.
Frequently Asked Questions
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What is functional constipation?
Functional constipation refers to a chronic condition where bowel movements are infrequent or hard to pass. It is often associated with abdominal discomfort.
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What is Transcranial Alternating Current Stimulation (tACS)?
tACS is a non-invasive neuromodulation technique that delivers low-intensity electrical currents to targeted brain areas to modulate activity patterns.
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Who is eligible to participate in the study?
The study focuses on individuals with a dual diagnosis of Functional Constipation and Somatic Symptom Disorder. For specific inclusion criteria, visit the provided link.
Conclusion
This trial represents a significant step forward in addressing complex and refractory cases of constipation, particularly in patients with overlapping psychosomatic conditions. Stakeholders should keep track of emerging findings from this study, as they may set the foundation for new treatments and regulatory pathways for tACS devices.
Disclaimer
This article is intended for informational purposes only and is not legal or medical advice. Stakeholders should consult official guidelines and regulations for comprehensive understanding.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07323407?term=medical+device