Consensus Recommendations for rTMS in Depression: Not Entirely Correct!

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See reply by McClintock et al and article by McClintock et al

Consensus Recommendations for rTMS in Depression: Not Entirely Correct!

To the Editor: The recently published consensus recommendations1 on use of transcranial magnetic stimulation (TMS) for treating depression are very thorough and the most comprehensive recommendations published to date. However, there were several points that should not be accepted into guidelines.

First, there is no evidence that adding pharmacotherapy to TMS improves response and remission rates. A study of active TMS + placebo medication, active TMS + active medication, sham TMS + active medication, and sham TMS + placebo medication has not been done yet.

Second, the article states (in the section Evidence Basis for Antidepressant Efficacy) that 21% of subjects in the H1-coil multicenter trial2 failed 3 or more medications in the current trial (second-stratum group). In fact, 41.5% of the patients failed 3 or more medications in the current episode.2

Third, in the same section, the article compares the H-coil second-stratum group to Sequenced Treatment Alternatives to Relieve Depression (STAR*D) steps/levels 3 and 4, while in fact only level 4 is comparable to the H1-coil second-stratum group (patients in both failed 3 or more medications in the current episode). Moreover, the 28.9% remission rate in the second-stratum group with the H1-coil occurred in the context of a double-blind antidepressant-free study, while the 13% remission rate for STAR*D step 4 was in an open-label study, a design in which patients typically have higher response and remission rates.3

Fourth, there is no evidence for any role of a physical examination component to evaluate the medical safety of rTMS. Every clinical trial for TMS included a physical examination component at baseline and endpoint, and none reported any significant findings. While our colleagues in primary care are eliminating more and more screening physical examination components that lack evidence, we should not add physical examinations to the treatment of depression patients.

Fifth, informed consent is a process and not a form, and the process should not differ between pharmacologic or TMS treatments. The potential for serious side effects from medications is much greater than from TMS, and there is no need for a consent form for medications or TMS separate from a general consent for treatment. Rather, there should be documentation of a risk-benefit conversation with the individual patient. There are advantages to an informed consent form, in that it simplifies the documentation, but there is no advantage to signing a consent form a second time for a second treatment course.

Sixth, confirmation or redetermination of the motor threshold (MT) in patients on medications should probably be done by the operators on a daily basis. The most likely cause of a TMS-induced seizure is a change in cortical excitability, measured as the resting MT. The most likely culprit for MT changes is medication (a change in intake, absorption, or metabolism).

Seventh, patients with implanted vagal nerve stimulation devices (or other conductive metal in the neck) can be treated with rTMS with no safety concerns.4,5 Regardless of the coil, there is no magnetic field or induced electrical field that reaches the neck.6,7

References

1. McClintock SM, Reti IM, Carpenter LL, et al; National Network of Depression Centers rTMS Task Group, American Psychiatric Association Council of Research Task Force on Novel Biomarkers and Treatments. Consensus recommendations for the clinical application of repetitive transcranial magnetic stimulation (rTMS) in the treatment of depression. J Clin Psychiatry. 2018;79(1):16cs10905. PubMed CrossRef

2. Levkovitz Y, Isserles M, Padberg F, 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. PubMed CrossRef

3. Rush AJ, Trivedi MH, Wisniewski SR, et al. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006;163(11):1905-1917. PubMed CrossRef

4. Philip NS, Carpenter SL, Carpenter LL. Safe use of repetitive transcranial magnetic stimulation in patients with implanted vagus nerve stimulators. Brain Stimul. 2014;7(4):608-612. PubMed CrossRef

5. Sperling W, Kornhuber J, Wiltfang J, et al. Combined VNS-rTMS treatment in a patient with therapy resistant depression. Pharmacopsychiatry. 2007;40(1):39-40. PubMed CrossRef

6. Roth Y, Amir A, Levkovitz Y, et al. Three-dimensional distribution of the electric field induced in the brain by transcranial magnetic stimulation using figure-8 and deep H-coils. J Clin Neurophysiol. 2007;24(1):31-38. PubMed CrossRef

7. Lu M, Ueno S. Comparison of the induced fields using different coil configurations during deep transcranial magnetic stimulation. PLoS One. 2017;12(6):e0178422. PubMed CrossRef

Aron Tendler, MDa,b

[email protected]

Roman Gersner, PhDb

aAdvanced Mental Health Care Inc., Royal Palm Beach, Florida

bBrainsway Ltd., Jerusalem, Israel

Potential conflicts of interest: Drs Tendler and Gersner have a financial interest in Brainsway Ltd., the manufacturer of the H1-coil.

Funding/support: None.

Role of the sponsor: None.

J Clin Psychiatry 2018;79(1):17lr11851

To cite: Tendler A, Gersner R. Consensus recommendations for rTMS in depression: not entirely correct! J Clin Psychiatry. 2018;79(1):17lr11851.

To share: https://doi.org/10.4088/JCP.17lr11851

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