FDA Action Needed: Approval of Maintenance Transcranial Magnetic Stimulation (TMS) for Depression
Image: Scientist by aerofotografialincoln (CC0)
Synopsis: Transcranial Magnetic Stimulation (TMS) is one of the safest and most effective treatments for major depression. The FDA has approved it to treat teenagers and adults but only for a time-limited course of care. For most people, that is all the treatment they need. For others, they require maintenance (continuation) TMS. This article reviews the research and rationale that shows the need for the FDA to approve maintenance TMS now.
BY LEN LANTZ, MD / 9.22.24; No. 72 / 8 min read
Disclaimer: Yes, I am a physician, but I’m not your doctor, and this article does not create a doctor-patient relationship. This article is for educational purposes and should not be seen as medical advice. You should consult with your physician before you rely on this information. This post might also contain affiliate links. Please click this LINK for the full disclaimer.
What TMS is and how it works
Transcranial Magnetic Stimulation (TMS) utilizes magnetic pulses to stimulate an area of the brain's left frontal lobe. This area of the brain – the dorsolateral prefrontal cortex (DLPFC) – is underactive in depression (Baxter, et al. Arch Gen Psychiatry. 1989) and is associated with a cascade of other changes in the brain that occur in major depression.
When you stimulate the DLPFC region of the brain with TMS, depression usually lifts (Schutter. Psychological Medicine. 2009). Most treatment protocols involve up to 36 treatments, delivered once daily over 6-8 weeks.
In my clinical experience of treating with TMS over 100 patients with severe, chronic depression, 50% of the patients achieved complete remission (entirely free from depression), and an additional 25% of patients achieved a meaningful response, cutting depressive symptoms in half.
TMS is safe and highly effective for depression even after traditional treatments of psychotherapy and antidepressants have failed. For more background on TMS for depression, please see my article “Transcranial Magnetic Stimulation (TMS) – the Best New Depression Treatment.”
Fantastic research on TMS under the direction of Dr. Nolan Williams at Stanford with their SNT protocol showed that achieving a 79% remission rate in adults in 5 days is possible. For more information on some of the newest TMS research, see my article “A New Kind of TMS for Depression: SAINT Becomes Stanford Neuromodulation Therapy (SNT).”
Some people need more extended TMS treatment
It’s terrific for people who achieve complete remission from their depression from a standard course of TMS; however, for the best outcome, some people require additional TMS treatments over a more extended period. For example, some people are slower to respond and reach remission near the end of 36 treatments. These patients require an extended course of therapy to essentially “lock in” their gains.
Alternately, some people receiving TMS improve only partially during treatment and require a longer course of treatment to achieve remission of their depression.
Maintenance TMS therapy might involve treatment that:
Continues past the initial 36 treatments with a longer, slower tapering of treatment sessions before ending.
Restarts for 5 or 10 treatments over a week or two, as needed, if there is a relapse to depression following the initial 36 treatments.
Continues with a single TMS treatment once every 1-4 weeks for months or years to maintain improvement of depression.
Research supports the clinical observations of physicians who provide TMS care that more treatment sessions result in better outcomes (Avery, et al. J Clin Psychiatry. 2008; Yip, et al. Brain Stimulation. 2017).
Above, I mentioned the astonishing results of Stanford’s SNT protocol. Even though Stanford’s SNT protocol delivers its TMS treatments over five days, a patient receives 50 individual treatments (Cole et al. Am J Psychiatry. 2021). That’s nearly 50% more treatments than a traditional treatment protocol!
Research also supports an entire, repeat course of TMS therapy if the initial course does not result in remission (Pridmore, et al. Malays J Med Sci. 2019). In that study, 75% of people who did not achieve remission in their first course of TMS achieved remission with a second course.
FDA approval of maintenance TMS is overdue
The problem in continuing TMS (maintenance treatment) beyond the initial 36 treatments (acute treatment) is not that the doctor or the patient is unwilling to continue treatment. The problem is that health insurance companies are reluctant to pay for the treatment.
Health insurance companies in the US typically refuse to pay for treatments not approved by the FDA. After the FDA approved TMS (acute treatment) in 2008 for depression, it took years to compel insurance companies actually to start paying for the treatment.
Many health insurance companies still block TMS for acute treatment based on self-serving “medical necessity criteria.” For more information on medical necessity criteria, please see my article, “The Problem of Insurance Company Physicians Blocking Medical Care.”
Because the FDA has not yet approved maintenance TMS, insurance companies have routinely denied coverage for the treatment. Unfortunately, in the US, where most families cannot afford to pay for expensive medical procedures with their personal funds, blocking payment for medical care is essentially the same as stopping the care itself.
The acute and maintenance treatment divide
Most treatments in psychiatry fall under one of two categories to be researched and approved by the FDA: acute and maintenance. Most drug companies and device makers first try to get their medications and devices approved for acute treatment, because it is easier to prove that it works.
It makes sense that it’s easier to show that Prozac helps depression if a research study only lasts four weeks rather than four years. Frankly, it would be awesome if most people who had major depression just had to take Prozac for four weeks, experienced freedom from depression, stopped the medication, and the depression remained gone.
Unfortunately, even for a first-time episode of depression, treatment often takes longer, and a person continues therapy for much longer. When it’s time to wean off medication, some people do great, and some don’t.
With many psychiatric conditions, patients might require lifetime treatment with medication, therapy, or other interventions to keep the symptoms gone or reduced. Many people need to continue treatment to keep their depression gone, which means that they need to extend treatment past the “acute” phase and receive maintenance (or continuation) therapy.
The need for access to maintenance therapy is a necessity for nearly all psychiatric conditions, from anxiety, to depression, to schizophrenia, to bipolar disorder.
The FDA approves nearly all depression treatments for both acute therapy and maintenance therapy. Here is a chart that breaks it down:
Image: FDA Approval of Depression Treatments by Len Lantz (CC BY-NC-ND)
The exception above is startling! It’s especially concerning because TMS is arguably safer, has fewer side effects, and is more effective than nearly all the other depression treatments listed in the chart above. We need action from the FDA to correct this oversight.
There is ample research evidence that supports maintenance TMS
There are over two dozen research articles that support the use of maintenance TMS as safe and effective for depression. I’ve pared down the list below to include the most relevant studies:
Image: Research on Maintenance TMS for Depression by Len Lantz (CC BY-NC-ND)
We now have nearly 1,000 research case examples spanning over twenty years that support the use of maintenance TMS for the treatment of depression (Wilson, et al. Journal of Affective Disorders. 2022). The FDA is overdue in its approval of this treatment.
The elephant(s) in the room
If the information I’ve provided above is not flooring you as it has me, I’ll make a few final points, which certainly should be enough to get the FDA to act and approve maintenance TMS.
Major depression is a life-threatening illness and is the #1 cause of suicide.
The US loses around 50,000 people to suicide every year. These deaths are preventable because depression is treatable.
TMS saves lives. TMS is highly effective in treating depression. Maintenance TMS is also highly effective at maintaining that improvement and preventing a recurrence of depression.
EVERYBODY already knows that maintenance TMS WORKS when delivered appropriately
TMS researchers know
TMS doctors who supervise care know
TMS patients and their family members know
TMS technicians who deliver care know
TMS device makers know
Even health insurers know (they just don’t want to pay for it)
It is critically important that the FDA approves maintenance TMS for depression. It is one of their most glaring omissions in mental health over the last two decades. Without FDA approval, most people will not be able to afford to receive this life-saving treatment.
Approving maintenance TMS for depression is an easy slam dunk for the FDA
As I was writing this article, I was thinking about some of the good actions of the FDA, even ones they made this year. For example, on 3/22/2024, the FDA approved TMS for the treatment of adolescent depression in kids aged 15 and older.
The FDA's decision to approve TMS for kids will save the lives of many of our young people. It took leadership, and it was the right decision. I wrote about that decision in my article, “A New Treatment for Adolescent Depression: FDA Approves Transcranial Magnetic Stimulation (TMS).”
I feel the same way about maintenance TMS for depression. As a psychiatrist who treats the severe depression of both kids and adults, I can tell you that we need this treatment approved ASAP. As a provider of TMS for over four years with over 100 patients receiving the treatment in my office, I can also tell you that TMS works not just in the initial phase of treatment. I have provided maintenance TMS to many patients for whom no other treatments worked. Maintenance TMS saved their lives.
While a small percentage of people can already access maintenance TMS by paying for it out of their personal funds, most people’s access to the treatment is currently severely limited. Until the FDA acts to approve maintenance TMS for depression, people will be left in the lurch with fewer options for their care due to health insurance companies that refuse to pay their fair share. All of us need the action and leadership of the FDA to approve maintenance TMS for depression.
For further reading, check out:
Len’s Article, “Transcranial Magnetic Stimulation (TMS) – the Best New Depression Treatment”
Len’s Article, “A New Kind of TMS for Depression: SAINT Becomes Stanford Neuromodulation Therapy (SNT)”
Len’s Article, “The Problem of Insurance Company Physicians Blocking Medical Care”
Len’s Article, “A New Treatment for Adolescent Depression: FDA Approves Transcranial Magnetic Stimulation (TMS)”
Transcranial Magnetic Stimulation: Clinical Applications for Psychiatric Practice by Drs. Bermudes, Lanocha and Janicak
Network Neuroscience by Dr. Frohlich
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