Bipolar Today

---

Brainsway, Inc., has received what is called an “Investigational Device Exemption” from the FDA to begin a study to examine the clinical effectiveness of their deep transcranial stimulation therapy for the treatment of bipolar disorder. This approval does not mean that the treatment has been FDA approved, but only that it has been approved for study. Their goal is to show that their device is safe and is at least as effective as a currently approved device, at which point they would put forward what is called a Premarket Notification 501k, which would allow their device to be sold for the intended purpose. The device works by putting magnetic coils close to the skull of the patient, then generating a magnetic field within the brain that activates nerve cells in a manner similar to that of ECT, though less invasively. The treatment is already sold under another Premarket Notification 501k for major depressive disorder. More discussion of this exemption can be found here.

Commentary

Poor magnets. They had their reputation ruined by the mysticism around magnetism in the Nineteenth Century. However, the theory behind this sort of treatment is sound, working in a method similar to that of ECT. Drs. Frederick K. Goodwin and Kay Redfield Jamison held out moderately high hopes for transcranial magnetic stimulation in their 2007 book, Manic-Depressive Illness: Bipolar Disorders and Recurrent Depression (page 783), pointing out that, in two meta-analyses, the effect was “highly significant statistically.” However, the evidence continues to be imperfect, largely due to the size of studies and differences in how the therapy has been applied. More studies like the one approved by the FDA will hopefully improve the data we have about this novel form of treatment.

Related posts:

1. MRIs May Help With Depression: Scientific American
2. Cariprazine Shows Promise, But Trial Worrisome
3. CA Family Receives $2.2 Million After Attempted Suicide
4. “Brain Pacemaker” Shows Promise
5. The FDA Versus the WMA: Why the Recent Cariprazine Trial Was Unethical