Neurolief's Relivion device, already approved for migraine treatment, is showing promise as a novel, take-home treatment for major depressive disorder (MDD), particularly in patients with treatment-resistant depression. The device delivers targeted neuromodulation via branches of the trigeminal nerve to modulate brain circuits implicated in depression.
Clinical Trial Efficacy
According to Dr. Linda Carpenter, lead clinical trial researcher at Butler Hospital, the multi-site clinical trial demonstrated the efficacy of Relivion in treating depression. Patients were randomized to either an active or sham device, with the active group showing a superior outcome. The full data package has been submitted to the FDA.
"The clinical trial proved the efficacy [of the device] by randomizing people in active or sham, right? The data demonstrated a superior outcome for the people who had active [devices]," Dr. Carpenter stated.
FDA Breakthrough Designation and Expedited Review
The FDA has granted Relivion a "breakthrough designation," which aims to accelerate the regulatory process for devices that address unmet medical needs. This designation reflects the need for accessible, at-home treatments for patients with treatment-resistant depression who may not be able to attend frequent clinic visits for transcranial magnetic stimulation (TMS) or electro-convulsive therapy (ECT).
Accessibility and Future Implementation
Neurolief anticipates FDA approval in early 2025, after which the device can be commercially marketed. The exact business model is still under consideration, but it is expected that Relivion will be available by prescription and monitored by a physician, potentially including primary care doctors in addition to psychiatrists.
"It could be that you come to your doctor’s office, they supervise you using it a couple of times until they are confident that you can use it properly. And then you take home the device, use it, come back, check in every two or three or four weeks, something like that," Dr. Carpenter explained.
Addressing Unmet Needs in Depression Treatment
Approximately one-third of patients with depression do not respond to standard antidepressant treatments, representing a significant unmet need. According to Dr. Carpenter, of the 21 million patients with depression, 9 million are treated with antidepressants, and 3 million meet the criteria for treatment-resistant depression.
Mechanism of Action and Future Studies
Relivion stimulates branches of the trigeminal nerve, sending signals to the brainstem and influencing brain circuits involved in mood regulation. While the precise mechanism of action is still being investigated, future studies will explore how the device changes brain connectivity and function using brain scans before and after treatment.
Dr. Carpenter emphasized the importance of rigorous scientific validation, noting that many devices marketed for depression lack the support of large, randomized controlled trials. She hopes Relivion will become a regular treatment option for depression, provided access and affordability issues are addressed.
"We studied this, with people using it every day, active or sham, for a period of eight weeks... As soon as the FDA approval happens, then those will be next types of studies that we are doing. And also, we will be doing more mechanism of action studies. To do scans, before and after treatment, to look at how is it changing connections in the brain, and the way it does."
