Neurostimulation technology, once confined only to interrupting the nerve signals linked to chronic pain and movement disorders, is now expanding into new realms. Several systems have been cleared by the FDA to reduce incontinence, and technology from Theranica has now been greenlit to both prevent and treat migraine. Meanwhile, a handful of recent studies have suggested that neurostimulation could also be used to restore movement in paralyzed limbs.
There’s also a growing push to use neuromodulation to treat major depressive disorder, though the systems that have so far been cleared by the FDA to do so require patients to visit a clinic for treatment sessions. Enter: Sooma Medical, which is developing a neurostim headset that’s meant to deliver its depression-targeting treatments from the comfort of a user’s own home.
That intended change of venue has helped Sooma secure breakthrough device designation from the FDA, the devicemaker announced Monday. The recognition sets up a designated channel of communication between the company and the regulator and will ensure that Sooma’s eventual application for FDA clearance is at the top of the agency’s pile for review.
The FDA bestows the tag on up-and-coming devices in hopes of shortening the time it takes to bring much-needed treatments to the market—a mission shared by Sooma, whose CEO Tuomas Neuvonen said in the release, “We are committed to making this innovative treatment accessible to patients in the U.S. as quickly as possible.”
The Finnish company’s therapy system—which is already approved in Europe—relies on transcranial direct current stimulation, or tDCS. It works by sending a mild electrical current via electrode to specific areas of the brain, with an aim of interrupting and normalizing the nerve signals linked to depression and therefore easing the symptoms of the condition.
The prescription-only system is housed within a flexible headset that users can set up themselves in a matter of minutes. After inserting the electrodes into the stretchy cap, covering them with hydrogel pads and soaking the pads with saline solution, patients fit the cap over their heads and can begin treatment right away.
Each treatment session lasts 30 minutes—after which the electrodes automatically shut off—with the therapy initially designed to take place five days a week for three weeks. After that treatment period, according to Sooma, doctors should assess their patients’ progress and determine whether the neuromodulation therapy should continue.
According to a study published last year, after an average of 16 sessions with Sooma’s device, just over half of the 410 participants saw their depressive symptoms reduced by at least 50%. Nearly 20% of the group experienced full remission of the condition, while almost 95% registered at least some clinically important difference in their symptoms after the treatment period.
Sooma isn’t alone in the race to bring neuromodulation-based depression treatments out of the clinic and into the home. The FDA has doled out breakthrough designations to at least other such systems in the last few years.
One of the nods went to Abbott last summer, in recognition of a possible treatment-resistant depression indication for its implanted deep brain stimulation system, which can be monitored and controlled remotely through Abbott’s NeuroSphere Virtual Clinic technology and which has previously been used to treat the symptoms of movement disorders like Parkinson’s.
And in 2020, the FDA offered a leg up to Neurolief’s Relivion DP system, which centers around a headset and connects to a smartphone app and cloud platform where patients and healthcare providers can monitor progress and adjust treatments as needed.