A Two-site Pilot Randomized 3 Day Trial of High Dose Left Prefrontal Repetitive Transcranial Magnetic Stimulation (rTMS) for Suicidal Inpatients

George, Mark S.; Raman, Rema; Benedek, David M.; Pelic, Christopher; Grammer, Geoffrey; Stokes, Karen T.; Schmidt, Matthew; Spiegel, Chad; DeAlmeida, Nancy; Beaver, Kathryn L.; Borckardt, Jeffrey J.; Sun, Xiaoying; Jain, Sonia; Stein, Murray B.

doi:10.1016/j.brs.2014.03.006

Cited by 156 publications

(159 citation statements)

References 42 publications

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“…Previous studies did not indicate any evidence of emergent suicidal ideation during TMS treatment (Janicak et al 2008) and a recent study of an accelerated protocol even suggests, that suicidal risk can be reduced by rTMS (George et al 2014a). There is a considerable suicide risk in this patient group independent from treatment.…”

Section: Discussionmentioning

confidence: 94%

Bilateral prefrontal rTMS and theta burst TMS as an add-on treatment for depression: A randomized placebo controlled trial

Prasser

Schecklmann

Poeppl

et al. 2014

The World Journal of Biological Psychiatry

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Section: Discussionmentioning

confidence: 94%

Bilateral prefrontal rTMS and theta burst TMS as an add-on treatment for depression: A randomized placebo controlled trial

Prasser

Schecklmann

Poeppl

et al. 2014

The World Journal of Biological Psychiatry

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“…In another 3 days-trial of delivering high doses of rTMS on left prefrontal cortex in patients with suicidal ideations, a more rapid decline in suicidal thinking has been observed in the active rTMS group compared to the sham group. The rather intense stimulation schedule (delivering 54,000 stimuli over 3 days), was feasible and safe with minimum side effects, and particularly with no worsening of suicidal thinking (58). Desmyter et al examined in a randomized, sham-controlled trial, the effects and safety of accelerated intermittent Theta Burst Stimulation (iTBS) on suicide risk by using the Beck scale of suicide (BSI).…”

Section: Discussionmentioning

confidence: 99%

Anti-Suicidal Efficacy of Repetitive Transcranial Magnetic Stimulation in Depressive Patients: A Retrospective Analysis of a Large Sample

et al. 2020

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Background: Suicide is a major public health problem. About 90% of suicide victims have one or more major psychiatric disorder, with a reported 20-fold increased risk for suicide in patients with affective disorders in comparison with healthy subjects. Repetitive transcranial magnetic stimulation (rTMS) has been established as an effective alternative or adjunctive treatment option for patients with depressive disorders, but little is known about its effects on suicide risk. Objective: For the assessment of the effectiveness of rTMS on suicidal ideation and behaviors, we performed a retrospective analysis of a large sample of patients with depressive disorders, who were treated with rTMS. Methods: We analyzed the records of 711 TMS in-and outpatients with depressive affective disorders in a tertiary referral hospital between 2002 and 2017. Out of these patients we were able to collect Hamilton depression rating scale (HAMD) data of 332 patients (180 females, 152 males; age range 20 to 79 years; mean age 47.3 ± 12.3) for which we analyzed the change of suicidal ideation by using item 3 (suicidality) of HAMD. Results: Out of all 711 patients treated with rTMS for their depression, one patient (0.1%) committed suicide during the TMS treatment. In the statistical analysis of the subsample with 332 patients there was an overall amelioration of depressive symptoms accompanied by a significant decrease in the suicidality item with a medium effect size. Decrease in suicidality was not inferior to changes in other items as indicated by effect sizes. Fortyseven percent of patients showed an amelioration in suicidality, 41.3% of patients did not show a change in their suicidality's scores, and 11.7% of patients showed an increase in suicidality's scores from baseline to final rating. Correlation of item 3 (suicidality) and item 7 (drive) demonstrated a significant positive association, revealing improved drive with a parallel decreased suicidality. Conclusion: Based on the proposed data, there is no evidence that rTMS increases the risk for suicide during the course of the treatment. Conversely, rTMS tends to reduce

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“…Out of 190 patients, 120 were fully adherent (63%) and 154 were considered as completers (81%). In another trial, George et al (2014) defined true completers as patients receiving all treatment sessions with the entire number of pulses, even though this was an inpatients study [24]. 27 out of 41 patients were considered as true completers (66%), 9 did not receive the full treatment (22%) and 5 dropped-out (12%).…”

Section: Findings' Summarymentioning

confidence: 99%

Strategies for replacing non-invasive brain stimulation sessions: recommendations for designing neurostimulation clinical trials

Thibaut

O’Brien

Fregni

2017

Expert Review of Medical Devices

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Introduction: Despite the potential impact of missed visits on the outcomes of neuromodulation treatments, it is not clear how this issue has been addressed in clinical trials. Given this gap in the literature, we reviewed articles on non-invasive brain stimulation in participants with depression or chronic pain, and investigated how missed visits were handled. Areas covered:We performed a search on PUBMED/MEDLINE using the keywords: "tDCS", "transcranial direct current stimulation", "transcranial magnetic stimulation¨, "depression", and "pain". We included studies with a minimum of five participants who were diagnosed with depression or chronic pain, who underwent a minimum of five tDCS or TMS sessions. A total of 181 studies matched our inclusion criteria, 112 on depression and 69 on chronic pain. Of these, only fifteen (8%) articles reported or had a protocol addressing missed visits. This review demonstrates that, in most of the trials, there is no reported plan to handle missed visits.Expert commentary: Based on our findings and previous studies, we developed suggestions on how to handle missed visits in neuromodulation protocols. A maximum of 20% of missing sessions should be allowed before excluding a patient and these sessions should be replaced at the end of the stimulation period.

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A Two-site Pilot Randomized 3 Day Trial of High Dose Left Prefrontal Repetitive Transcranial Magnetic Stimulation (rTMS) for Suicidal Inpatients

Cited by 156 publications

References 42 publications

Bilateral prefrontal rTMS and theta burst TMS as an add-on treatment for depression: A randomized placebo controlled trial

Bilateral prefrontal rTMS and theta burst TMS as an add-on treatment for depression: A randomized placebo controlled trial

Anti-Suicidal Efficacy of Repetitive Transcranial Magnetic Stimulation in Depressive Patients: A Retrospective Analysis of a Large Sample

Strategies for replacing non-invasive brain stimulation sessions: recommendations for designing neurostimulation clinical trials

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