Journal: Brain Stimulation 13:1858 (2020)
Authors: Harvey SA, Tendler A, DeLuca M, Stehberg J, Naimark R, Schmidt D, Müir O, McMillan C, Shakir S, Antin T, Ghelber D, Duffy W, Lender N, Goodman M, Isserles M, Melman K, Cabrera J, Munasifi FA, Jones D, Kaur J, Mania I, Faris S, Faruqui Z, Insaf S, Kim D, Rushing S, Nelson B, Zangen A, Roth Y.
Background:
Despite the availability of Deep TMS for MDD since 2013 when it was cleared by the FDA, its real-world clinical practice efficacy is unknown.
Objective:
To demonstrate the real-world clinical practice efficacy of Deep TMS H1 Coil for MDD.
Methods:
All Deep TMS sites were offered compensation for treatment and outcome data. Outcome measures included clinician–based scales (CGI-S, HDRS-21 and MADRS) and self-questionnaires (PHQ-9, BDI, IDS). Analyses included remission and response rates after 20 and 30 Deep TMS sessions, number of sessions and days required to reach first response, first remission, sustained response, and sustained remission.
Results:
9/481(6%) of H1 sites submitted treatment and outcome data for 1040 patients. Remission (response) rates were 36.2% (65.1%) and 48.1% (72.5%) after 20 and 30 Deep TMS sessions, respectively. Remission rates were highest when assessed by HDRS. Mean number of sessions (days) for first response were 10.3 (18.6) with CGI-S, 14.9 (24.9) with PHQ-9, 18.0 (33.3) with BDI, and 17.1 (28.3) with HDRS. Mean number of sessions (days) for first remission were 14.4 (28.5) with CGI-S, 21.8 (45.0) with PHQ-9, 20.6 (42.8) with BDI, and 18.1 (30.7) with HDRS. The rates of patients who achieved first remission (response) were 50.5% (62.1%) with CGI-S, 58.9% (84.6%) with PHQ-9, 75.3% (86.7%) with BDI, and 78.5% (89.7%) with HDRS. The rates of patients who achieved sustained remission (response) were61.4% (90.0%) with CGI-S, 47.0% (80.0%) with PHQ-9, 65.9% (79.5%) with BDI, and 70.9% (83.2%) with HDRS.
Conclusions:
The majority of MDD patients benefit from Deep TMS, with the onset of improvement before the 20th session. Many initial non-responders benefit from a longer treatment course.
