Treating Depression As Easy As 1-2-3-4

By Bob Marshall, Chief Editor, Med Device Online

Depression is a mood disorder that causes a persistent feeling of sadness and loss of interest. Also called major depressive disorder or clinical depression, it affects how you feel, think, and behave, and can lead to a variety of emotional and physical problems. More than just a bout of the blues, depression isn't a weakness, and you can't simply "snap out of it." You may have trouble doing normal day-to-day activities like sleeping, eating, or working, and sometimes you may feel as if life isn't worth living.

Depression may require long-term treatment. To be diagnosed with depression, the symptoms must be present for at least two weeks. In 2015, around 16.1 million adults aged 18 years or older in the U.S. — about 6.7 percent of all American adults — had experienced at least one major depressive episode in the last year.

A Treatment, Not A Cure

Neuronetics, Inc. is a privately held medical device company focused on developing non-invasive therapies for psychiatric and neurological disorders using MRI-strength magnetic field pulses. Transcranial magnetic stimulation (TMS) uses a targeted pulsed magnetic field, similar to what is used in a magnetic resonance imaging (MRI) machine. NeuroStar TMS Therapy, a noninvasive form of neuromodulation, is indicated for the treatment of major depressive disorder in adult patients who have failed to receive satisfactory improvements from prior antidepressant medication in the current episode. I talked with Chris Thatcher, president and CEO of Neuronetics, about his technology, and he was quick to point out that it "is not a cure for depression. Depression, unfortunately, is a relapsing/remitting disease."

1-2-3-4

Thatcher talked me through the four-step treatment process:

1. The patient reclines comfortably in a treatment chair similar to that found in a dentist's office — in a similarly sized room — and is awake and alert throughout.
2. A small curved device containing the magnetic coil rests lightly on the patient's head. The device is affixed to a mechanical arm for ease of positioning, much the same as a dental X-ray machine.
3. The device delivers focused magnetic stimulation directly to the targeted areas of the brain's mood center, the cerebral cortex. With this targeted approach, NeuroStar treats depression right at the source, delivering the right dose to the right location every time. "Every person has a different threshold to activate their neurons," Thatcher said, adding that treatment consists of 19-37 minute sessions, administered five days a week, for up to six weeks. Treatment time depends on the doctor's recommendation.
4. The patient can immediately resume normal activities.

Effects, Side Effects, And After Effects

During treatment, the patient hears a clicking sound and feels a tapping sensation on the head. The most common side effect is generally mild-to-moderate pain or discomfort, at or near the treatment area, during the session. This side effect typically occurs only during the first week of treatment, and is temporary. There are no effects on alertness or understanding; patients being treated with NeuroStar TMS Therapy can drive themselves to and from their treatment sessions.

"After 30 treatment sessions, 58 percent of the people respond to the treatment (meaning they have a 50 percent reduction in their symptoms), and 37 percent of them go into remission," Thatcher explained. "When you compare that to drug therapy, first-line drug therapy is about 28-percent effective at achieving remission and, by the time [the patient tries] their fourth drug, their odds of remission are less than 7 percent."

In a National Institute of Mental Health (NIMH) funded, independent, randomized controlled trial, patients treated using a clinical-trial version of the NeuroStar TMS System were four times more likely to achieve remission, compared to patients receiving sham treatment. TMS therapy is contraindicated in people with non-removable conductive metal in or near the head.

Somebody's Gonna Pay For This! Eventually…

After securing initial FDA clearance for the NeuroStar TMS in October 2008, Neuronetics battled to earn for the device experimental status from the Centers for Medicare & Medicaid Services. Having created the product category, Neuronetics then encountered insurance companies who said "Congratulations! You got cleared, but we don't have anyone asking for [the device], so we're not going to provide any insurance coverage," Thatcher said. "That's the way of pioneering in the U.S. for medical device."

Since NeuroStar is not an ophthalmic implant, or a similar therapy, where all of the insurance structure already is established, the company scratched and clawed for six years to convince Aetna, Cigna, Blue Cross/Blue Shield, and Medicare administrators that the device has a health-economic advantage to the patient. As of about 18 months ago, Thatcher said, NeuroStar enjoys coverage from all Medicare regions, 100-percent, and 95 percent of private insurers cover the therapy. Having overcome reimbursement hurdles and exhibited effective performance, NeuroStar is rapidly expanding its U.S. footprint, currently boasting over 800 NeuroStar systems in 49 states.

Transforming Lives For Those With Depression

"Some people have been depressed for 25 years. They cannot remember not being depressed," he said, segueing into the story of an experience he had with a user of Neuronetics' technology: A Los Angeles man's first round of NeuroStar therapy had propelled his depression into remission after a 25-year battle. Two-and-a-half years later, the patient had slipped back into depression, and returned for another round of treatments. Some time around the patient's 15^th session, he encountered Thatcher and started crying. "I asked him why he was crying and he said, ‘Chris you don't understand, for my co-pay, and what I'm paying since insurance is now covering it, I'll always have a cure for the rest of my life. It's a life-saver.'"

What's Next?

So what are the future plans for Neuronetics? The company is planning a labeling expansion early in 2019 to expand its patient population beyond the 22-to-70 age range, so as to include younger patients. "We know that the second leading cause of death in adolescents in the U.S. is suicide, which is most often the end stage of some psychological disorder — most often depression," Thatcher explained. To support its labeling expansion request, Neuronetics has a study underway to demonstrate the therapy's clinical utility with users aged 12 to 21.

Neuronetics also is evaluating future clinical trials to address two significant unmet needs in psychiatry: Post-Traumatic Stress Disorder and Bi-polar Disorder.