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Clinical Trial
. 2024 Apr;38(4):485-491.
doi: 10.1177/02692163241234799. Epub 2024 Mar 14.

Accelerated transcranial magnetic stimulation for psychological distress in advanced cancer: A phase 2a feasibility and preliminary efficacy clinical trial

James Downar  1   2   3   4 , Julie Lapenskie  1   2 , Koby Anderson  1 , Jodi Edwards  1   5 , Christine Watt  1   2   3   4 , Michel Dionne  1   2   3   4 , Jill Rice  1   2   3   4 , Monisha Kabir  1 , Peter Lawlor  1   2   3   4 , Jonathan Downar  6
Affiliations
Clinical Trial

Accelerated transcranial magnetic stimulation for psychological distress in advanced cancer: A phase 2a feasibility and preliminary efficacy clinical trial

James Downar et al. Palliat Med. 2024 Apr.

Abstract

Background: Psychological and existential suffering affects many people with advanced illness, and current therapeutic options have limited effectiveness. Repetitive transcranial magnetic stimulation (rTMS) is a safe and effective therapy for refractory depression, but no previous study has used rTMS to treat psychological or existential distress in the palliative setting.

Aim: To determine whether a 5-day course of "accelerated" rTMS is feasible and can improve psychological and/or existential distress in a palliative care setting.

Design: Open-label, single arm, feasibility, and preliminary efficacy study of intermittent theta-burst stimulation to the left dorsolateral prefrontal cortex, 600 pulses/session, 8 sessions/day (once per hour) for 5 days. The outcomes were the rates of recruitment, completion of intervention, and follow-up (Feasibility); and the proportion of participants achieving 50% improvement on the Hamilton Depression Rating Scale (HDRS) or Hospital Anxiety and Depression Scale (HADS) 2 weeks post-treatment (Preliminary Efficacy).

Setting/participants: Adults admitted to our academic Palliative Care Unit with advanced illness, life expectancy >1 month and psychological distress.

Results: Due to COVID-19 pandemic-related interruptions, a total of nine participants were enrolled between August 2021 and April 2023. Two withdrew before starting rTMS, one stopped due to clinical deterioration unrelated to rTMS, and six completed the rTMS treatment. Five of six participants had a >50% improvement in HDRS, HADS-Anxiety, or both between baseline and the 2 week follow up; the sixth died prior to the 2-week follow-up. In this small sample, mean depression scores decreased from baseline to 2 weeks post-treatment (HDRS 18 vs 7, p = 0.03). Side effects of rTMS included transient mild scalp discomfort.

Conclusions: Accelerated rTMS improved symptoms of depression, anxiety, or both in this small feasibility and preliminary efficacy study. A larger, sham-controlled study is warranted to determine whether rTMS could be an effective, acceptable, and scalable treatment in the palliative setting.

Trial registration: NCT04257227.

Keywords: Transcranial magnetic stimulation; anxiety; depression; end of life care; existential distress; palliative care.

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Conflict of interest statement

Declaration of conflicting interestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: JD and JD have a financial interest in Ampa, Inc., a company that manufactures rTMS devices. The other authors have no conflicts of interest to declare.

Figures

Figure 1.
Figure 1.
Depression scores among participants.
See this image and copyright information in PMC

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