Never Too Late: Safety and Efficacy of Deep TMS for Late-Life Depression

Abstract

Repetitive transcranial magnetic stimulation (rTMS) is an effective and well-established treatment for major depressive disorder (MDD). Deep TMS utilizes specially designed H-Coils to stimulate the deep and broad cerebral regions associated with the reward system. The improved depth penetration of Deep TMS may be particularly important in late-life patients who often experience brain atrophy. The aim of this phase IV open-label study was to evaluate the safety and efficacy of Deep TMS in patients with late-life MDD. Data were collected from 247 patients with MDD aged 60-91 at 16 sites who had received at least 20 Deep TMS sessions for MDD. The outcome measures included self-assessment questionnaires (Patient Health Questionnaire-9 (PHQ-9), Beck Depression Inventory-II (BDI-II)) and clinician-based scales (21-item Hamilton Depression Rating Scale (HDRS-21)). Following 30 sessions of Deep TMS, there was a 79.4% response and 60.3% remission rate on the most rated scale. The outcomes on the PHQ-9 were similar (76.6% response and 54.7% remission rate). The highest remission and response rates were observed with the HDRS physician-rated scale after 30 sessions (89% response and a 78% remission rate). After 20 sessions, there was a 73% response and 73% remission rate on the HDRS. Consistent with prior studies, the median onset of response was 14 sessions (20 days). The median onset of remission was 15 sessions (23 days). The treatment was well tolerated, with no reported serious adverse events. These high response and remission rates in patients with treatment-resistant late-life depression suggest that Deep TMS is a safe, well-tolerated and effective treatment for this expanded age range of older adults.

Keywords: Deep TMS; H-coil; late-life depression; major depressive disorder; phase IV study; rTMS.

Figure 1

Age distribution of the patients recruited in this study.

Figure 2

Remission and response rates based on individuals that received 20 sessions (gray) or 30 sessions (black) of Deep TMS with the H1 coil. (A) Aggregate data of the most rated scale used for each patient. Subsets of data for the PHQ-9 (B), BDI-II (C) and HDRS (D) are also shown. The number of patients with available data at each interval is presented beside each data point.

Figure 3

Cumulative incidence (1 survival) plot of response. The event is the first occurrence of ≥50% improvement from baseline in the most rated score among subjects monitored at a given number of sessions. The number of patients monitored at a certain number of sessions is shown next to the data points.