Objective To make a case for the Medicare benefits schedule (MBS) rule, that depressed patients who benefit from transcranial magnetic stimulation (TMS) have a lifetime limit of 50 treatments, to be reconsidered.Conclusion Evidence proves TMS can produce remission in major depressive disorder/treatment resistant disorder (MDD/TRD) when medication has failed. This is a relapsing disorder, and further treatments are usually required (but are prevented by this limit). We suggest the limit be raised to 70 treatments (2 courses, or similar) per year.

ObjectiveTo present the perspective of professionals working in the field of transcranial magnetic stimulation (TMS) regarding the regulations which impact the availability of government subsidisation via Australian Medicare Benefits Schedule Item Number rebates to patients with major depressive disorder (MDD) who are seeking TMS treatment.ConclusionsWe argue that three regulations should be withdrawn: (1) that patients who received TMS prior to 1 November 2021 are ineligible for TMS rebates after 1 November 2021; (2) that every person is subject to a limit of 50 TMS treatments in a lifetime; and (3) that rebates are not available for maintenance TMS. We also conclude that consideration should be given to the provision of rebates for TMS treatments when it is delivered as a first-line treatment for MDD.

Objective:A patient with major depressive disorder (MDD) was receiving transcranial magnetic stimulation (TMS). A little over halfway through the course the patient was bereaved and experienced normal sadness. Our objective is to describe the tracking and outcome of this common emotionally distressing event. Method:Routine assessments conducted at the centre include the six-item Hamiton depression rating (HAMD6) scale, the Clinical Global Impression-Severity (CGI-S) scale, and the Subjective Depression Scale (SDS6). In addition, the Daily Sadness Scale (DSS) is applied at each treatment day; this is a single question asking how much sadness/depression is being experienced. Results:On the 19th treatment day, the patient was bereaved and experienced appropriate sadness. The pathological state (MDD) resolved, as reflected by changes in the psychometric tools. Following the death, normal sadness emerged and lessened over a few weeks. Conclusion:This case illustrates that while TMS can effectively treat MDD, it does not prevent the emergence of sadness in uncomplicated bereavement.

Objective To report the outcomes of transcranial magnetic stimulation (TMS) treatment of patients with acute major depressive disorder (MDD), with particular attention to the performance of the individual assessment tools, including two new subjective mood scales.Methods Patients with MDD were treated with up to 35 daily TMS sessions. Objective quantification of mood utilised the Hamilton Depression Rating Scale (HAM-D6) and the Clinical Global Impression-Severity scale (CGI-S). Subjective quantification was made using the Subjective Depression Scale (SDS6) and a new Daily Emotion Score (DES) - a single question which is asked daily.Results Ninety consecutive patients (58 females; 64.4%) with a mean age of 46.9 years were included. Using HAM-D6 criteria, 51 patients (56.7%) achieved remission. Scores obtained using the different tools correlated well at the same time point, especially at the conclusion of TMS therapy. The only statistically significant independent predictors of remission were the percentage improvement at session 10 (relative to baseline) in the SDS6 (p = .0026) and in the DES (p = .043).Conclusion The SDS6 was confirmed as a valuable companion for the HAM-D6. The DES correlated with the other subjective tool (SDS6); the latter, in particular, may also have utility in predicting treatment outcome.

Background: Major depressive disorder (MDD) is frequently chronic and relapsing. The use of maintenance or continuation transcranial magnetic stimulation (TMS) has received clinical and some research support. Objective: To conduct a case series study to report the outcomes of once-weekly (OW) or once-fortnightly (OF) continuation TMS in a real-life setting. Methods: We offered OW or OF TMS sessions to patients with MDD in remission or partial remission/relapse. Results: Ten patients received OW TMS and four received OF TMS, for 8 to 46 weeks. No patients in either group who were in remission or partial remission at baseline experienced a relapse. Improvements in HAMD6 and CGI-S scores were statistically significant or of borderline significance for the total sample and the OW group. Conclusions: This naturalistic, open-label observational study indicates that OW TMS is effective as maintenance therapy in MDD, while also offering some support for OF TMS maintenance in preventing relapse.

OBJECTIVES:To report an observational case series study of sustained, once-weekly continuation transcranial magnetic stimulation (TMS) provided with the aim of maintaining remission in patients with major depressive disorder (MDD). METHODS:Once-weekly TMS treatments were provided to 7 patients (median age of 54 years) with chronic relapsing MDD: 4 of these patients entered the study in remission according to the six-item Hamilton depression rating scale (HAM-D6) and were followed for more than 12 months, and 3 patients entered the study in HAM-D6 partial remission/relapse and were followed for more than 6 months. RESULTS:All patients remained clinically well throughout the study. The 4 patients who entered in remission were maintained in HAM-D6 remission or partial remission. The 3 patients who entered the study in HAM-D6 partial remission/relapse were maintained free of clinical depression. CONCLUSIONS:Seven patients with a history of relapsing MDD were provided with once-weekly continuation TMS and remained free of clinical relapse for more than 6 or 12 months. While the study had a small sample size, the clear, real-world outcomes warrant further investigation.

Background:Transcranial magnetic stimulation (TMS) is effective in the management of treatment resistant major depressive disorder (MDD) and has recently become widely available. Our aim was to explore the literature for evidence of the mechanism of action. Method:We examined our own accumulating TMS library, the reference lists of all available papers and used a search engine to collect information. We collated and examined this information under relevant heading. Results:TMS produces a large number of physiological changes including site of stimulation neurochemical, brain wave and blood flow effects, and distant structure effects including neurotransmitter effects and volume increase. TMS also corrects generalized and local functional connectivity (FC) abnormalities which are a feature of MDD. Conclusion:TMS produces a range of physiological changes. It is unclear which of these underpin its antidepressant. It is likely more than one work synergistically to this end-almost certainly the capacity to correct MDD induced FC abnormalities makes a strong antidepressant contribution.

When a patient is to receive transcranial magnetic stimulation (TMS) it is necessary to first determine the resting motor threshold (RMT)—the minimum intensity of magnetic pulse required to activate the target area. The RMT is measured by placing the coil on the scalp/hair over the motor area and delivering various quantities of energy—we are looking to trigger a slight motor response of a contralateral finger. The precise location of the motor cortex is not initially known and is found by slight relocations of the coil. During this process we sometimes notice the patient sometimes evidences a twitch in the cheek (on the same side) or a blink of an eye (on the same or both sides). It has been concluded the twitch in the cheek is a contraction of the masseter muscle and the blinking is contraction of the orbicularis oculi. These contractions are considered benign phenomenon and clinicians in the field dismiss them as the result of ‘superficial nerve stimulation’. But what we mean by ‘superficial nerve stimulation’ is unclear. Neural tissue is more easily activated than muscle tissue, and nerve depolarization results in activation of all downstream muscle fibers. Thus, the depolarization of ambient nerves could possibly explain these events. However, examination of ‘superficial nerve stimulation’ as the explanation for these masseter and orbicularis oculi contractions raises questions. When seeking finger movement, we stimulate in a region some centimeters superior to the pinna and a little posterior to the coronal plane through the tragus. Given these landmarks, it is unclear (1) how the masseter nerve could be depolarized, as it is at least 12 cm distant and always deep to the masseter, and (2) why we fail to stimulate the trunk of the facial nerve after exiting the stylomastoid foramen and before it divides into branches—it is closer than the masseter nerve and would produce contractions across the face. The ‘the superficial nerve stimulation’ explanation is lacking. When the masseter or orbicularis oculi is triggered and the position and the strength of the stimulus are held constant, the contractions remain constant in timing and strength— reminiscent of reflexes. We therefore searched for tissue components which could support the theory that the twitches sometimes observed during RMT determinations are reflex responses—i.e. magnetic pulses causing depolarization of sensory nerves, which lead to activation of motor nerves and muscle contraction.

Objective:Major depressive disorder (MDD) which comes to transcranial magnetic stimulation (TMS) is prone to relapse. Cluster maintenance (CM) TMS is courses of 5 treatments delivered over 2.5-5 days, separated by monthly or greater non-treatment periods. Our aim was to characterize the outcomes of 100 courses of CM TMS. Method:This was a Quality Assurance/Clinical Audit study. We studied consecutive CM TMS courses provided to private hospital inpatients. Mood was rated (on admission and discharge) using the six-item Hamilton depression rating (HAMD6) and the Clinical Global Impression - Severity (CGI-S) scales. We also applied recent STAR*D criteria which are designed to measure the 'clinical change' expected to impact patient function [16]. Results:For the total sample, using the HAMD6, 83% of courses featured relapse or partial relapse on admission, and 81% featured remission on discharge. Of 46 courses featuring HAMD6 relapse on admission, 74% featured remission on discharge. For the 100 courses the HAMD6 discharge scores were significantly lower than the admission scores (p = 2.0 × 10-24), as were the CGI-S scores (p = 1.8 × 10-25). Using STAR*D criteria for people in relapse or partial relapse on admission, CM TMS provided least a 'clinically meaningful' outcome in 82% of the cases. Conclusion:For courses featuring relapse or partial relapse on admission, CM TMS converted greater than 70% to remission at discharge. It produced statistically significant reductions in HAMD6 and CGI-S scores, and using STAR*D criteria, at least 'clinically meaningful' change was extensively demonstrated. This evidence indicates CM TMS should be readily available to people living with relapsing MDD.

Objective: To examine reports of Transcranial Magnetic Stimulation (TMS) during pregnancy for evidence of fetal risk. Method: PubMed was used to locate relevant literature for the years 1998–2020 and reference lists were examined for materials not located electronically. Results: Ten reports were located dealing with 67 births over 20 years. Stimulation was applied is all trimesters, at low and high frequency, and as intermittent theta-burst stimulation. No mother or baby experienced a serious event. Conclusions: Certainty awaits large, standardized studies. However, the available reports provide no evidence that TMS to mother during pregnancy has detrimental effects on the fetus.

Researchers recently reported a naturalistic retrospective study of motor threshold (MT) data from 374 patients treated with TMS for depression from 2000 to 2019 [[1]Cotovio G. Oliveira-Maia A. Paul C. Viana F. da Silva D. Seybert C. et al.Day-to-day variability in motor threshold during rTMS treatment for depression: clinical implications.Brain Stimul. 2020; 14 (PMID: 34329797): 1118-1125https://doi.org/10.1016/j.brs.2021.07.013Abstract Full Text Full Text PDF Scopus (2) Google Scholar]. MT was measured each day of treatment, “using the visual method”. It is reported that compared to the baseline MT, for each patient, each day, the MT varied (increasing or decreasing) on average more than 5%. It was also stated that “more extreme variations (≥25% above or below the first MT)” could occur. The researchers’ conclusion was that when MT is only determined once, at the commencement of treatment, there is danger of “underdosing” and “overdosing” with potential therapeutic and safety consequences. In consequence the authors suggest “daily or at least weekly MT determination”. The recommended stimulation intensity range is 110–120% MT [[2]Milev R. Giacobbe P. Kennedy S. Blumberger D. Daskalakis Z. Downar J. et al.Canadian network for mood and anxiety treatments (CANMAT) 2016 clinical guidelines for the management of adults with major depressive disorder: section 4. Neurostimulation treatments.Can J Psychiatr. 2016; 61 (PMID: 27486154): 561-575https://doi.org/10.1177/0706743716660033Crossref PubMed Scopus (225) Google Scholar]. However, in blinded studies, successful treatment has been achieved at 80% [[3]George M. Wassermann E. Kimbrell T. Little J. Williams W. Danielson A. et al.Mood improvement following daily left prefrontal repetitive transcranial magnetic stimulation in patients with depression.Am J Psychiatr. 1997; 154 (PMID: 9396958): 1752-1756https://doi.org/10.1176/ajp.154.12.1752Crossref PubMed Scopus (456) Google Scholar], 90% [[4]Pascual-Leone A. Rubio B. Pallardo F. Catala M. Transcranial magnetic stimulation of the left dorsolateral prefrontal cortex in drug-resistant depression.Lancet. 1996; 348 (PMID: 8684201): 233-237https://doi.org/10.1016/s0140-6736(96)01219-6Abstract Full Text Full Text PDF PubMed Scopus (0) Google Scholar] and 100% [[5]Theleritis C. Sakkas P. Paparrigopoulos T. Vitoratou S. Tzavara C. Bonaccorso S. et al.Two versus one high-frequencyrepetitive transcranial magnetic stimulation session per day for treatment-resistant depression: a randomized sham controlled trial.J ECT. 2017; 33 (PMID: 28445181): 143https://doi.org/10.1097/YCT.0000000000000412Crossref PubMed Scopus (8) Google Scholar] MT. Thus, if treatment is provided in the recommended stimulation intensity range, it is extremely unlikely that the variation in MT could be so great that the stimulation provided (according to the initial MT determination) could be too low to render clinical benefit. At the request of neurosurgeons who were planning to remove epileptic foci, we have attempted to induce seizure (to display foci) in conscious patients using standard therapeutic TMS devices. We have been unsuccessful, having to desist due to patient discomfort before any evidence of seizure activity whatsoever. There is no evidence to indicate that the individual's TMS MT and seizure threshold (should there be one for a particular individual) have a fixed relationship. It is probable they are independent, and the lowering of the MT does not mean there would be a lowering of any TMS seizure threshold. Thus, there is no evidence that variability leading to the lowering of the TMS MT increases the risk of TMS induced seizure. Members of the Clinical TMS Society participated in a survey to clarify the risk of TMS induced seizure [[6]Taylor J. Newberger N. Stern A. Phillips A. Feifel D. Bentensky R. et al.Seizure risk with repetitive TMS: survey results from over half a treatment sessions.Brain Stimul. 2021; 14 (PMID: 34133991): 965-973https://doi.org/10.1016/j.brs.2021.05.012Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar]. The overall rate was 0.31 seizures per 10 000 treatments. For apparatus using generic figure- 8 coils the rates were lower (for example, the Neuronetics device the estimated rate was 0.03 seizures per 10 000 treatments). We accept that during a course of TMS for the treatment of depression, day to day variation in MT of at least 5% (and perhaps more) may occur. However, in our opinion, the risk of inadequate treatment or increased risk of seizure due of this variation is not substantiated. Daily re-determination of MT would be expensive and given the current evidence, unjustified. This work did not receive any specific grand from funding agencies in the public, commercial, or not-for-profit sectors.

Objective: To examine the impact (if any) of a course of transcranial magnetic stimulation (TMS) on irritability occurring in association with acute major depressive disorder (MDD). Method: In a naturalistic study, patients with MDD according to DSM-5 criteria were given 20 daily TMS treatments. A visual analogue scale for irritability (VAS-I) was developed. Objective tools included the six-item Hamilton Depression Rating Scale (HAMDS6) and the Clinical Global Impression - Severity (CGI-S). Results: Fifty patients received 53 courses. Forty-seven courses achieved remission on both HAMD6 and CGI-S and six courses did not achieve remission with either. Irritability significantly reduced when MDD remission was achieved but was unchanged when remission was not achieved. Conclusion: TMS reduces irritability occurring in association with MDD when this treatment affects MDD remission, but not when remission is not affected.

Transcranial magnetic stimulation (TMS) is a safe and effective treatment of treatment resistant major depressive disorder (MDD). However, MDD is a chronic disorder and relapse is common. The leading method of managing those cases of MDD who respond to TMS, but continue to relapse, is to provide maintenance TMS – short courses of 5 treatments over 2.5 days, repeat at monthly (or greater) intervals. The strategy is to increase the interval between treatment clusters and for patients to be discharged when they have been able to remain well for a couple of months. However, patients and doctors are both frequently apprehensive about increasing the between cluster interval, and patients tend to remain in treatment programs for long periods. We present a protocol and instrument to assist in moving from treatment to discharge, which we have found helpful.

Background: Tiredness is used in some characterizations of major depressive disorder (MDD). Transcranial magnetic stimulation (TMS) lowers all symptoms of MDD. Objective: To explore whether, 1) a visual analogue scale (VAS) for tiredness is a valid and reliable measure of a feature of MDD, and 2) TMS treatment reduces subjective tiredness occurring in MDD. Method: A naturalistic study of treatment with 10 Hz TMS. Completed pre- and post-treatment: HAMD-6, a visual analogue scale (VAS-6), the Clinical Global Impression – Severity (CGI-S) and a ‘VAS-tiredness’. Two groups received TMS. Acute course: N=52 participants suffering acute MDD, received 20 treatment courses (total courses 86). Relapse prevention (RP) course: N=26 participants suffering chronic relapsing MDD received scheduled episodic courses over 3 days; (total courses 266). VAS-tiredness scores were compared with the standardized tool results. Results: There were significant medium to large correlations between pre- and post-treatment VAS-tiredness and the standard depression measures (HAMD-6 .406 to .447, VAS-6 .446 to .525, CGI-S .348 to .407; all p<.001). TMS treatment produced a significant reduction in VAS tiredness in both (Acute course and RP) groups (main effect: F(1,350)=147.3, p<.001, η2=.30). The two groups displayed difference in the pre-treatment VAStiredness with the Acute group having higher scores pre-treatment. Post-treatment tiredness scores were similar. Conclusion: -tiredness is a valid measure of a feature of MDD. VAS-tiredness provides potentially useful information and complements standard mood tools. TMS treatment can reduce tiredness in MDD.

BACKGROUND:There is interest in using TMS to keep patients with severe relapsing depression as well as possible, once remission has been achieved. This has been conceptualized as 'maintaining' the remission. One protocol employs series of 5 TMS sessions over 3 or 5 days, at about monthly intervals. We have suggested this practice is better conceptualized as early relapse (ER) TMS.AIM:To determine whether 5 TMS sessions at about monthly intervals are effective in keeping patients relatively well, and whether the concept of ER-TMS can be supported.METHOD:Prospective, naturalistic, 10-month study, administering pre- and post-TMS series, HAMD6, visual analogue scale for mood, and CGI-S.RESULTS:Thirty-nine patients (72% female) received 168 series of 5 TMS sessions and remained in the program for 21 weeks on average. Pre-post-treatment scores showed significant reductions on all measures. Post-series HAMD6 score 3.30 (2.28) indicates remission has been achieved. Pre-series scores of 6.24 (2.78) indicate a post-series decline in mood, in the direction of relapse. Before TMS series 70% were no longer in remission (being in partial remission or relapse), and after TMS series, 79% were in remission.CONCLUSION:In severe relapsing depression, monthly series of TMS move mood from the relapse/partial remission range in the direction or remission and is appropriately termed early relapse ER-TMS. Long-term availability of ER-TMS to patients with severe relapsing depression deserves consideration.

Background: There is interest in using TMS to extend the benefits gained at TMS induced remission.

‘TMS Tasmania’ is located at St Helen’s Private (psychiatric) Hospital in Hobart. It was established in 2004, as the world’s first private provider of TMS. All treatment (so far) has been applied for depressive disorders. We have provided 18 600 treatment sessions and greater than 54 million pulses. We have witnessed no deaths or seizures.

Background: Major depressive disorder (MDD) commonly takes a relapsing form. Transcranial magnetic stimulation (TMS) has be suggested as a means of maintaining remission. Brief courses of TMS at about monthly intervals appear to provide health benefits. Objective: To examine whether such brief courses of TMS are better conceptualized as maintaining remission, or as the provision of early relapse treatment. Method: 25 series of treatment (18 different patients) were considered. Pre- and post-treatment 6-item Hamilton Depression Rating Scale (HAMD6) and 7 visual analogue scales (VASs) were collected, along with pretreatment Clinical Global Impression-Severity (CGI-S) and post-treatment CGIImprovement (I). Results: Pre-treatment HAMD6 and CGI-S indicated that many patients were symptomatic and in early relapse. Post-treatment HAMD6 indicated that many patients had achieved remission, and this was supported by the CGI-I. The VAS scores also improved. Conclusions: Short courses of TMS at about monthly intervals have beneficial results and are better conceptualized as early relapse treatment (ERT).