One of this week’s reading assignments for our resident doing a clinical TMS rotation through our Spokane clinic was an article published earlier this year by Dr. Debra Kim. Coincidentally, Dr. Kim gave our Clinical TMS Society grand rounds tonight on treating pregnant women with TMS. In 2010, Dr. Kim published one of the first articles using TMS with pregnant women. She stated that many women with depression did not want to take medicine while pregnant. She described an open label study where 10 women were treated with right sided 1 Hz stimulation for 20 sessions with 300 pulses per treatment. She reported a 70% response rate with a 50% reduction in HAM-D scale. Mothers and babies were fine.
Earlier this year, Dr. Kim published an article that was an extension of her first paper with some modifications. She reports of 22 women who were randomly and equally assigned to TMS treatment or a sham group, with 20 sessions of TMS to the right dorsolateral prefrontal cortex at 1 Hz as a single train of 900 pulses per session at 100% motor threshold. The treatment group had a much greater response and remission rate compared to the sham group. Response rates were 81.82% for the active and 45.45% for the sham coil. Remission rates were 27.27% for the active coil, 18.18% for the sham coil.
As large as the differences were between these two groups, they did not statistically separate from each other. This is interesting, as the treatment and sham conditions have not separated from each other in several large clinical trials.
This study illustrates several interesting points. First, by measuring estradiol and progesterone during the study, Dr. Kim demonstrated that TMS was safe and effective without harm to mother or baby.
Secondly, the sample size of 22 women in this study was too small to generate the power to separate treatment from sham conditions. A larger sample size would have most likely separated. It also reflects the apparent current difficulty to get treatment separation in depression studies, whether using medication or TMS. Earlier this year, a major Veterans Affairs TMS study did not have treatment groups separating from sham (Yesavage, 2018).
A good friend of mine, Charlie Nemeroff, wrote an analysis that accompanied the published VA study commenting on some factors at play. Although patients may receive sham treatment, their experience is not placebo. Like what happens in our offices, the patients are met by bright, caring professionals who show an interest in the patient, establish rapport with them, and end up spending a lot of time with the patient. This is often more human interaction than the patient has recently experienced, and the interaction is very pleasant and healthy. There is also an increasing belief among patients, especially those who volunteer for clinical studies, that treatments are increasingly more effective, and that treatment will help them.
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Kim, D. R., Epperson, N., Paré, E., Gonzalez, J. M., Parry, S., Thase, M. E., ... & O'Reardon, J. P. (2011). An open label pilot study of transcranial magnetic stimulation for pregnant women with major depressive disorder. Journal of Women's Health, 20(2), 255-261.
Kim, D. R., Wang, E., McGeehan, B., Snell, J., Ewing, G., Iannelli, C., ... & Epperson, C. N. (2018). Randomized controlled trial of transcranial magnetic stimulation in pregnant women with major depressive disorder. Brain stimulation.
Yesavage, J. A., Fairchild, J. K., Mi, Z., Biswas, K., Davis-Karim, A., Phibbs, C. S., ... & O’Hara, R. (2018). Effect of repetitive transcranial magnetic stimulation on treatment-resistant major depression in US veterans: a randomized clinical trial. JAMA psychiatry, 75(9), 884-893.