May 2022 issue
May 31, 2022 | The market for treating psychiatric disorders with neuromodulation therapy continues to progress as vendors report progress and investigators share new research findings.
We reported last month on the formation of Inner Cosmos, which is developing a subcutaneous stimulation system for treating depression [NBR Apr22 p1]. Earlier this month, Neuronetics, the first neuromodulation firm to gain FDA clearance of magnetic stimulation for depression, announced clearance for its rTMS system as an adjunct for treating adult patients suffering from obsessive-compulsive disorder. The company’s NeuroStar system allows providers to treat both major depression and OCD without the need for additional hardware upgrades or purchases.
“NeuroStar receiving FDA clearance for OCD is important for my practice because more patients will have access to an effective and safe TMS treatment for both MDD and OCD without needing to buy any new equipment,” said Scott West, CMO at Nashville NeuroCare Therapy.
Earlier this month, European vendor Flow Neuroscience, announced it received an IDE from the FDA to launch a clinical trial in which participants will test the effectiveness of Flow’s at-home headset in reducing depressive symptoms. The trial will include 270 participants in London and Houston across two research centres, UTHealth and UEL. Another vendor, Fisher Wallace Labs in New York City, reported that a study, published in Annals of Neurology, found that tACS improved episodic memory and restored cholinergic dysfunction in Alzheimer’s disease.
At the recent meeting of the International Neuromodulation Society in Barcelona, Thomas Schlaepfer, a professor of psychiatry at University Hospital Freiburg, gave attendees an update on the status of DBS for depression. His team is targeting the superior lateral branch of the medial forebrain bundle for both depression and OCD. He highlighted the joint neural circuits involved with both disorders and common features, such as anxiety and social withdrawal, and response to SSRI medications.
Schlaepfer described the FORESEE trials, conducted in collaboration with Boston Scientific. In the Phase I trial, 16 patients with TRD received DBS of the slMFB and were randomized to sham or real stimulation for two months after implantation. All patients reached the response criterion and most responded within a week. Half were classified as remitters after 1 year of stimulation. In the FORESEE III randomized control trial, which began in October 2018, investigators noticed a clear efficacy signal in 32 patients implanted.
“Responders stay responders. As long as you stimulate, you have an anti-depressant response,” he said. “If for any reason you switch off the stimulation, you have an immediate reoccurrence of depression symptoms. You probably need the stimulation life-long.”
The Freiburg team is using Boston Scientific’s Vercise Gevia DBS system. The main objective of the FORESEE III trial is to assess the putative antidepressant efficacy of DBS in patients suffering from severe, treatment-resistant depression—patients who have not sufficiently improved under established antidepressant therapies such as psychotherapy, antidepressant drug therapy, and electroconvulsive therapy. The primary outcome measure will be the Montgomery-Asberg Depression Rating Scale. Schlaepfer said he expects to analyze the data from this trial in early 2023.
