Treating depression with magnetic energy
TMS therapy is on the rise, though questions linger and insurers balk
For Olivia, it was an alternative to electroconvulsive therapy. Depressed since she was 18, she had tried “a lot of different medications,’’ with little success. “They seem to make it possible for me to function and work,’’ she said, “but I never really felt very good.’’
So her psychiatrist recommended ECT, but Olivia, a social worker, worried she might suffer memory and cognitive problems, as some patients do, and dreaded the idea. She was then referred to the transcranial magnetic stimulation program at McLean Hospital in Belmont.
TMS uses a pulsing, powerful magnetic field to target neurons in an area of the brain thought to control mood and “reset’’ them to function normally. Unlike ECT, it requires no anesthesia and in studies worldwide has not been found to have any major side effects.
Olivia started with 20 sessions, once a weekday over four weeks.
“I noticed right away, within the first or second treatment, that my mood was better,’’ she said. “I felt like I used to feel as a kid: bright and alert and in a good place. It had been such a long time since I’d felt that way that I’d forgotten that was how I used to feel.’’
Olivia, 57, who asked that her full name not be used to protect her privacy, is one of about 80 people treated in McLean’s TMS clinic since it opened in October 2009, a year after the Food and Drug Administration approved a TMS protocol using a device called NeuroStar.
TMS has been used in research since the 1980s and offered abroad for years, in countries such as Australia, Brazil, Canada, and Israel, as well as at research-focused US facilities such as the Berenson-Allen Center for Noninvasive Brain Stimulation at Beth Israel Deaconess Medical Center.
But since the FDA approval, use of the therapy has dramatically increased. About 5,000 patients have been given NeuroStar TMS at about 350 sites nationwide, according to device maker Neuronetics Inc., of Malvern, Pa.; nine providers use the device in Massachusetts alone.
For some patients, like Olivia, TMS has been life-changing. Yet in clinical trials, TMS has shown only modest benefits: an average reduction in depression symptom scores of 22.1 percent for NeuroStar’s TMS protocol, compared with 9 percent for sham treatment.
TMS helps some people far more than others. A Neuronetics-sponsored study presented at the American Psychiatric Association meeting in May, for example, showed that 53.6 percent of patients responded to NeuroStar TMS, and 35.1 percent achieved remission. All patients had mild to moderate major depression.
And although the FDA-approved protocol is designed as a one-time treatment course, TMS benefits typically taper off. A study published in the journal Depression and Anxiety in 2009 found that 75.3 percent of patients were in remission at two months, but only 22.6 percent at six months.
Lingering questions about TMS have kept most health plans - and Medicare - from covering it. A spokesman for United Behavioral Health, for example, which serves one in six insured Americans, said the company has “reviewed the evidence’’ for TMS and found it “currently insufficient to show that there is a long-lasting positive impact for people with depression.’’
For McLean patients, this means paying $6,000 to $8,000 for a course of treatment; fees at Butler Hospital, in Providence, are similar, though there are some discounts available, said Dr. Linda Carpenter, chief of the Mood Disorders Program at Butler.
Patients may still appeal coverage denials and get at least partially reimbursed. Carpenter said all but one of her TMS patients in 2010 and 2011 had gotten reimbursed, but “not without a battle.’’
Olivia has an appeal pending with Blue Cross Blue Shield of Massachusetts; another McLean patient, Loren, 19, who also asked that her full name not be used, just won an appeal with Harvard Pilgrim Health Care, eight months after starting TMS.
Loren said that although the treatment was time-consuming at the beginning and felt slightly uncomfortable, it was worth trying.
“It’s not painful or anything like that. But it’s irritating; I can actually feel my muscles contracting,’’ she said.
Dr. Alvaro Pascual-Leone - he is director of the Berenson-Allen Center, a professor of neurology at Harvard Medical School, and an internationally recognized expert in TMS - said the need for additional research on TMS does not change the fact it is safe and has proven benefits.
“I do believe there is a need for improvement of the technology - we are only seeing the beginning . . . but it is already a very helpful tool,’’ he said.
Ongoing projects, including at his own lab, will refine TMS devices, clarify the precise neural mechanisms involved, combine TMS with imaging to better guide treatment, and allow much greater customization, Pascual-Leone said. Plus there are promising trials of TMS to treat other conditions, from brain damage to Parkinson’s disease.
At Butler, Carpenter has just begun recruiting patients for a trial of a TMS device made by the Waltham start-up NeoSync Inc. that is smaller than the NeuroStar and uses a single-lead electroencephalogram (EEG) to “tune’’ the TMS field to so-called alpha waves in the brain, which appear to be associated with relaxation and with neural coordinating functions.
One of NeoSync’s goals, said chief executive John Carnuccio, is to create a lower-cost TMS option that is portable, so patients could have initial treatments in a clinic but take home a smaller device to continue their therapy there, as they would with medications.
Carpenter said there is no evidence yet that the NeoSync device will be significantly more effective than the NeuroStar, but she’s enthusiastic about continuing to improve the therapy.
Already, 68 to 70 percent of Butler’s TMS patients show a response with NeuroStar, she said, with a 40 to 50 percent remission rate, and “TMS continues to see advances which make the treatment effect even stronger, better, smarter.’’
In the meantime, clinicians are finding ways to boost the long-term effects of TMS by setting up maintenance plans after the FDA-approved treatment course.
Loren, for example, goes to the McLean TMS center about once a month, sooner if she is not feeling well.
Dr. Oscar G. Morales, director of TMS at McLean, said one of the benefits of TMS is that it is tolerated well by patients, whereas drugs often have side effects that lead patients to stop taking them - “a major issue’’ - and ECT is tough even when it does not have cognitive impacts.
That said, the doctors stressed TMS is not a substitute for ECT, but rather a less aggressive therapy that may benefit many patients who would otherwise have no alternative. Most studies have found ECT to have greater benefits, Pascual-Leone said, and for people with major depression, especially those in crisis, it is unquestionably the better choice.
Beyond that, figuring out who will benefit from TMS and who won’t is one of the big open questions in the field, Pascual-Leone said. There is evidence the elderly don’t respond as well, for example; there are also studies looking at different ways to better administer TMS.
“I think there is a lot of need for more research,’’ Pascual-Leone said.
Marion Davis can be reached at firstname.lastname@example.org.