Study: Magnus Medical Depression Treatment Changes Abnormal Brain Signals

Magnus Medical Inc. is sharing promising results from a clinical trial that show treatment with SAINT Neuromodulation reverses abnormal brain signaling by changing the direction of brain signal flow in people with severe depression. Findings also reveal a new biomarker that may be helpful in the diagnosis and treatment of major depressive disorder (MDD).
 
“These findings have the potential to be a game-changer. This strongly supports the role of fMRI resting-state connectivity in our SAINT Neuromodulation System as a method of personalized targeting to treat underlying causes of depression, and suggests that this could be a fundamental biological signature of major depressive disorder,” Magnus medical Co-Founder/Chief Scientific Officer Brandon Bentzley, M.D., Ph.D., said. “Identifying other neural pathways could lead to the discovery of additional biomarkers that characterize other highly debilitating neuropsychiatric disorders.”
 
The study’s senior authors are Marcus E. Raichle, M.D., a Wolff distinguished professor of medicine at Washington University in St. Louis, Mo., and Nolan R. Williams, M.D., an associate professor within the Department of Psychiatry and Behavioral Sciences at Stanford Medicine. The study is published in the Proceedings of the National Academy of Sciences. 
 
Researchers conducted the first investigation of the relationship between resting-state fMRI brain activity, major depression, and treatment response to the U.S. Food and Drug Administration (FDA)-cleared SAINT Neuromodulation therapy. Findings show that treatment with SAINT for major depression produces changes in brain signaling by reversing the direction of abnormal brain signals in the bilateral anterior cingulate cortex (ACC)—the region that manages fundamental emotions, which predicts improvement in depression symptoms.
 
Notably, pre-treatment ACC signaling predicts depression severity and the likelihood of a person’s treatment response to SAINT therapy. This reverse signaling may also serve as a biomarker for diagnosing and treating major depressive disorder, the leading cause of disability worldwide.¹
 
Data from 33 patients diagnosed with treatment-resistant major depression, 23 of whom received treatment with SAINT and 10 who received a sham treatment, were compared to 101 healthy individuals. The fMRI data revealed that the anterior insula in healthy people—the region of the brain that supports subjective feelings and sensation—sent signals to the ACC, whereas in 80% of the people with depression, the flow of activity was reversed—the ACC sent signals to the anterior insula. The results also indicate that the higher quantity of abnormal signaling in the ACC is related to the severity of major depression.
 
The SAINT Neuromodulation System uses structural and functional magnetic resonance imaging (MRI) to inform a proprietary algorithm that identifies the optimal anatomic target for focused neurostimulation in people with MDD. This new approach is delivered on an accelerated, five-day timeline with targeting of the stimulation precisely tailored to each person’s brain connectivity.
 
Major depressive disorder is an episodic disorder that can last months or years.¹ According to the World Health Organization, more than 280 million people suffer from MDD globally, nearly half of whom have treatment-resistant depression, and many experience suicidal thoughts with no rapidly acting treatment options available to them.² More than 550,000³ U.S. adults are hospitalized annually for suicidal depression, and the highest peak in suicide attempt⁴ and completion is immediately after discharge from the hospital, representing an unmet need for rapid and effective treatment in a hospital setting.
 
Magnus Medical is a privately held medical device company driven to restore mental health. Magnus’ first FDA-cleared product is the SAINT Neuromodulation System, which received FDA Breakthrough Device Designation for its novel, rapid-acting therapy for treatment-resistant depression. The SAINT Neuromodulation System provides a new form of individualized neurostimulation for adults who have failed to achieve satisfactory improvement from prior antidepressant medications. 

References
¹ https://apps.who.int/iris/bitstream/handle/10665/254610/WHO-MSD-MER-2017.2-eng.pdf
² Friedrich MJ. Depression Is the Leading Cause of Disability Around the World. JAMA [Internet] 2017;317(15):1517–1517. Available from: http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2017.3826
³ https://www.hcup-us.ahrq.gov/db/nation/nis/nisdbdocumentation.jsp
⁴ https://pubmed.ncbi.nlm.nih.gov/28564699/