Based on an FDA-approved clinical trial protocol, this clinical trial enrolled 233 depression patients who did not respond to previous medication or could not tolerate it. The patients were distributed over 14 medical centers in the U.S., four in Israel, two in Germany and one in Canada.
The trial’s results were reported in 2012. The effects of five weeks of treatment were assessed using the Hamilton Depression Rating Scale (“HDRS-21”), a standard scale for rating depression severity. After five weeks of treatment, depressive symptoms were significantly reduced. There was a clinically and statistically significant difference between the REAL treatment group and the SHAM control group:
- 30.4% of patients in the treatment group achieved remission (defined as an HDRS-21 score of less than 10) compared to 14.5% in the control group (p=0.0148).
- Significant response to treatment (defined as a greater than 50% decrease from baseline HDRS-21 scores) was experienced by 36.7% of patients in the treatment group, compared to 20.5% in the control group (p=0.0148).
- A statistically significant difference of 3 points on the HDRS-21 was found between the treatment group and the control group (p=0.0126).
Following this trial, the FDA cleared Deep TMS for treating depression patients who tried one or more medication types without improving in the current depressive episode*.
* Levkovitz Y, Isserles M, Padberg F, Lisanby SH, Bystritsky A, Xia G, Tendler A, et al. Efficacy and safety of deep transcranial magnetic stimulation for major depression: a prospective multicenter randomized controlled trial. World Psychiatry 2015;14(1):64-73.
Figure 1. A sketch of the H1 coil at the treatment position over the frontal cortex.
Figure 2. The colored field map shows activation of the prefrontal cortex up to a depth of 3cm below the skull.