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Emory-Georgia Tech project studying PTSD receives FDA Breakthrough Device Designation
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Jennifer Johnson McEwen

Research from a study by Emory University-Georgia Institute of Technology on posttraumatic stress disorder (PTSD) using transcutaneous vagus nerve stimulation (tcVNS) has led to a Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the gammaCore nVNS device.

The Emory-Georgia Tech team was led by J. Douglas Bremner, MD, in the Departments of Psychiatry and Radiology, Emory University School of Medicine, and Omer T. Inan, PhD, at Georgia Tech School of Electrical and Computer Engineering and the Coulter Department of Bioengineering. Their research, built upon a strong mechanistic rationale and animal studies, shows tcVNS blocks sympathetic and inflammatory responses to memories of traumatic events in patients with PTSD, modulates brain responses to traumatic memory and reduces symptoms of PTSD by 31% when compared to a sham stimulation.

“Current treatments for PTSD involving medication and psychotherapy have limitations due to limited efficacy, possible side effects and the unwillingness of many PTSD patients to engage in therapies that involve reliving traumatic memories. gammaCore represents a new class of treatment separate from medication or psychotherapy that is safe, relatively free of side effects and does not involve costly and invasive procedures for implantation, like previous VNS devices approved by the FDA for treatment of refractory depression,” says Bremner.

PTSD is a highly prevalent and disabling disorder with approximately 15 million adults in the U.S. experiencing it each year. More than half of all patients with PTSD report severely impaired quality of life in areas including mood, social and family relationships, leisure activities, sense of well-being and life satisfaction.

The FDA’s Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The goal is to provide patients and health care providers with timely access to critical medical devices by speeding up their development, assessment and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the FDA’s mission to protect and promote public health.

About Brain Health at Emory University

As one of the nation’s premier research universities, Emory University is a leader in education, discovery and patient care related to the neurosciences. Faculty scholars, scientists, physicians and clinicians throughout the university collaborate on advancing knowledge associated with the brain and brain health. The Emory Brain Health Center combines neurology, neurosurgery, psychiatry and behavioral sciences, rehabilitation medicine and sleep medicine in a unique, integrated approach. Emory researchers are predicting, preventing, treating and curing diseases and disorders of the brain and addressing the growing global crisis associated with some of the most common ones. In addition, Emory’s neuroethics program explores the evolving ethical, legal and social impact of the neurosciences. Emory’s multidisciplinary approach is transforming the world’s understanding of the vast frontiers of the brain, harnessing imagination and discovery to address 21st-century challenges.

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