Patients have a number of treatment options for depression in both the device and drug realms, but they can take days or weeks to work. Boston's Tal Medical is developing something it claims can do the job far more quickly: a noninvasive neuromodulation treatment that appears to boost a patient's mood in about 20-30 minutes.
Other companies are pursuing neuromodulation device treatments--Brainsway ($BRIN) and Neuronetics, among them--but those devices can take several days or longer to work through multiple treatments. Antidepressant medication also produces results, but through many doses over several weeks. Tal, founded in 2010 by PureTech Ventures, neuroscientists and clinicians, believes low-field magnetic stimulation will work in a fraction of the time, with a single treatment.
The NIH's National Institute of Mental Health (NIMH) sees promise in the idea. Agency officials selected Tal Medical's technology to be the first focus of its RAPID research program (Rapidly Acting Treatments for Treatment Resistant Depression), an effort to promote development of promising new treatment options for drug-resistant depression. According to Andrew Miller, a Tal co-founder and its chief operating officer, the NIMH is funding 100% of a "multi-million-dollar" study (he would not disclose the specific funding amount) of its prototype device as part of this program.
The device includes an electromagnetic coil in plastic housing, about 15 inches in diameter. A patient lies down so the top of the head, above the eyes, is positioned inside. Over 20 minutes, the device delivers the low-field magnetic stimulation, and that's it.
"Patients don't feel anything" in terms of a physical sensation during treatment, Miller told FierceMedicalDevices in a telephone interview. He added that the low-field magnetic stimulation produces results without directly causing neurons to fire, through a magnetic field that is much lower in magnitude than the more commonly used transcranial magnetic stimulation.
Initial enrollment in the NIMH-backed study began in the 2013 second quarter, and 6 sites are now actively recruiting patients: Massachusetts General Hospital (which is managing the trial); Yale; Mount Sinai School of Medicine; Emory University; the University of Alabama, Birmingham; and UT Southwestern Medical Center in Dallas. Researchers have structured the trial as a proof-of-concept, double-blind sham-controlled study, with a goal of enrolling 90 patients with major depressive disorder.
While the NIMH is covering the trial costs, Tal is supplying prototype devices. If all goes well, Tal expects the trial to be finished by late 2014. The RAPID study is designed to validate initial promising data from McLean Hospital, a Boston-area facility from which Tal licensed its core technology, and also determine how long the treatment lasts. Additional clinical work will follow, Miller said, and future tests will explore using the treatment up to four times on a patient. A separate human biomarker study also began last fall. -- Mark Hollmer (email | Twitter)