Magnus Medical has announced positive findings from a clinical trial demonstrating that its SAINT Neuromodulation System reverses abnormal brain signalling in individuals with severe depression by altering the direction of brain signal flow.
The study also revealed a new biomarker that could assist in diagnosing and treating major depressive disorder (MDD).
The SAINT Neuromodulation System informs an algorithm that determines the optimal anatomic target for focused neurostimulation in MDD patients by deploying structural and functional magnetic resonance imaging (fMRI).
Researchers carried out the first evaluation examining the relationship between resting-state fMRI brain activity, major depression and treatment response to neuromodulation therapy, which is cleared by the Food and Drug Administration.
Research indicated that the use of SAINT in treating major depression leads to modifications in brain signalling by reversing the abnormal brain signal direction in the bilateral anterior cingulate cortex (ACC) region.
Data were collected from 33 patients diagnosed with treatment-resistant major depression, of which 23 received SAINT treatment, while ten received a sham treatment. These patient groups were compared to a group of 101 healthy individuals.
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The fMRI data demonstrated that the anterior insula in healthy individuals transmitted signals to the ACC, while the flow of activity was reversed in 80% of those diagnosed with depression.
Magnus Medical co-founder and chief scientific officer Dr Brandon Bentzley said: “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.”