FDA Approves TMS Device

[Anasazi23]

According to APA Headlines:

FDA approves transcranial magnetic stimulation device to treat patients with depression.
In the Health Journal column on the front page of the Wall Street Journal's (10/21, D1) Personal Journal section, Melinda Beck writes that in transcranial magnetic stimulation (TMS), a treatment in which "a psychiatrist places a metal coil against your head...rapid magnetic pulses penetrate your scalp and skull and produce a mild electrical current in the left prefrontal cortex of your brain." A TMS treatment "lasts about 40 minutes, and is done daily for four to six weeks." Patients who are "suffering from major depression...could start feeling better within a few weeks." According to psychiatrist Sarah Lisanby, M.D., of Columbia University, patients with depression have exhibited "improvement in mood, sleep, appetite, energy level, and a restoration of hopefulness and self-esteem."

The AP (10/21, Neergaard) reports that the Food and Drug Administration (FDA) "approved Neuronetics Inc.'s NeuroStar" TMS "therapy specifically for patients who had no relief from their first antidepressant." The agency "cleared the prescription-only NeuroStar based on data that found patients did modestly better when treated with TMS than when they unknowingly received a sham treatment that mimicked the magnet." Meanwhile, "the National Institutes of Health has an independent study under way now that tracks 260 patients, and may have initial results as early as next year." According to "Dr. Philip Janicak, of Rush University Medical Center in Chicago, who helped lead the NeuroStar study," TMS "is expected to cost $6,000 to $10,000, depending on how many treatments a patient needs."

Interesting to see where it goes from here.

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[OldPsychDoc]

I hear the contented mooing of a hundred cash cows...
😀

 

[chameleonknight]

How does this compare to ECT in terms of effectiveness?

 

[OldPsychDoc]

How does this compare to ECT in terms of effectiveness?

Fewer side effeects, less memory loss, no need for general anesthesia.
All it lacks is comparable effectiveness.

 

[Doc Samson]

Fewer side effeects, less memory loss, no need for general anesthesia.
All it lacks is comparable effectiveness.

Carl Salzman at Mass Mental describes BuSpar as "everything you'd want in an anxiolytic except efficacy."

 

[BobA]

Vagal nerve stimulators are FDA approved for treatment resistant depression as well, but nobody will pay for it.

 

[Faebinder]

What they need is a randomized trial of efficacy vs. Celexa or some other SSRI.

 

[whopper]

I'm wondering how TMS will fit into the managed care schema given its price. Its very expensive.

As for VNS, I've never seen anyone go on it other than people who needed it for a seizure disorder. Several people don't want something implanted into them. The subset of the population that may want to try it--those with treatment resistant depression-their attendings never even considered it for use.

 

[hippiedoc13]

I'm wondering how TMS will fit into the managed care schema given its price. Its very expensive.

It is expensive, but how does it compare with the cost of a course of ECT?

 

[percysmith]

Several studies have shown no efficacy differences between TMS and ECT, although a recent study showed an advantage for ECT in a study with older patients (TMS response is reduced in the elderly) and ECT is superior in patients with psychotic depression (Fitzgerald et al., "The use of rTMS and VNS in the tx of depression," 2007)

Based on reduction on HAMD scores, the NNT with TMS to have a response was comparable to the NNT in patients tx with antidepressants (O'Reardon et al., " Efficacy and safety of TMS in the acute tx of major depression: a multisite randomized RCT," 2007)

Side effects of TMS are usually mild, HA/scalp irritation. Rare side effects include seizures, switch to hypomania in bipolar depressed pts, and visual disturbances.

 

[BobA]

Several studies have shown no efficacy differences between TMS and ECT, although a recent study showed an advantage for ECT in a study with older patients (TMS response is reduced in the elderly) and ECT is superior in patients with psychotic depression (Fitzgerald et al., "The use of rTMS and VNS in the tx of depression," 2007)

Based on reduction on HAMD scores, the NNT with TMS to have a response was comparable to the NNT in patients tx with antidepressants (O'Reardon et al., " Efficacy and safety of TMS in the acute tx of major depression: a multisite randomized RCT," 2007)

Side effects of TMS are usually mild, HA/scalp irritation. Rare side effects include seizures, switch to hypomania in bipolar depressed pts, and visual disturbances.

Here's a head to head TMS vs ECT that showed ECT to be more effective in the short term, but no difference in HAM-D at 6 months. Am J Psychiatry 2007; 164:73–81

 

[CaMD]

Thanks for the article, BobA!!