Transcranial magnetic stimulation (TMS) for major depression: A multisite, naturalistic, observational study of acute treatment outcomes in clinical practice

Butler Hospital/Brown Department of Psychiatry, 345 Blackstone Boulevard, Providence, RI 02906, USA.
Depression and Anxiety (Impact Factor: 4.41). 12/2013; 29(7):587-96. DOI: 10.1002/da.21969
Source: PubMed


Few studies have examined the effectiveness of transcranial magnetic stimulation (TMS) in real-world clinical practice settings.
Forty-two US-based clinical TMS practice sites treated 307 outpatients with Major Depressive Disorder (MDD), and persistent symptoms despite antidepressant pharmacotherapy. Treatment was based on the labeled procedures of the approved TMS device. Assessments were performed at baseline, week 2, at the point of maximal acute benefit, and at week 6 when the acute course extended beyond 6 weeks. The primary outcome was change in the Clinician Global Impressions-Severity of Illness from baseline to end of acute phase. Secondary outcomes were change in continuous and categorical outcomes on self-report depression scales (9-Item Patient Health Questionnaire [PHQ-9], and Inventory of Depressive Symptoms-Self Report [IDS-SR]).
Patients had a mean ± SD age of 48.6 ± 14.2 years and 66.8% were female. Patients received an average of 2.5 (± 2.4) antidepressant treatments of adequate dose and duration without satisfactory improvement in this episode. There was a significant change in CGI-S from baseline to end of treatment (-1.9 ± 1.4, P < .0001). Clinician-assessed response rate (CGI-S) was 58.0% and remission rate was 37.1%. Patient-reported response rate ranged from 56.4 to 41.5% and remission rate ranged from 28.7 to 26.5%, (PHQ-9 and IDS-SR, respectively).
Outcomes demonstrated response and adherence rates similar to research populations. These data indicate that TMS is an effective treatment for those unable to benefit from initial antidepressant medication.

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    • "In this context, inter-hemispheric asymmetry of occipital alpha and prefrontal theta bands have been reported as a valuable pretreatment EEG features to differentiate responders from nonresponders (Bruder et al., 2008; Carpenter et al., 2012; Fitzgerald et al., 2006; George et al., 2000, 1995; Iosifescu et al., 2009; Pascual-Leone et al., 1996). Alpha asymmetry at baseline was also identified as a possible discriminator: responders showed greater alpha power over right than over left hemisphere, whereas nonresponders tended to show the opposite pattern (Bruder et al., 2008, 2001; Dell&apos;Osso et al., 2009; Dolberg et al., 2002; Knott et al., 1996; Tamas et al., 2007; Tenke et al., 2011; Ulrich et al., 1984). "
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    ABSTRACT: Major depressive disorder (MDD) and bipolar disorder (BP) are two different types of mood disorders, sometimes difficult to distinguish from their depressive symptoms, and for which repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex (DLPFC) has been proposed to treat refractory patients. Here we studied whether the electroencephalogram (EEG) at rest could be used to predict the therapeutic response to left DLPFC 10Hz rTMS, and to which extent BP and MDD patients show similar correlation between the clinical response and the cortical networks at rest. Eight MDD (6 females) and 10 BP patients (6 females) were included. The rTMS therapy consisted of 10 to 20 neuronavigated sessions, with 2000 pulses continuously applied at 120% motor threshold for each session. RTMS sessions at the beginning, middle and end of the therapy were performed while recording EEG signals. EEG spectral power was partitioned using the common physiological frequency bands and was statistically analysed at the scalp level and after cortical source reconstruction. We found significantly higher power in theta and beta bands in BP patients than in MDD patients, mainly localised in the prefrontal cortex. In addition, responders showed higher power in delta and theta bands in parietal regions and weaker frontal alpha power, when compared to non-responders. These preliminary findings on a small cohort suggest that pre-treatment EEG oscillatory patterns may have some predictive value regarding rTMS therapy, both for MDD and BP disorders. Copyright © 2015 Elsevier B.V. All rights reserved.
    Full-text · Article · Apr 2015 · Journal of Affective Disorders
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    • "This was confirmed in a recent meta-analysis of 34 studies [15], which concluded that rTMS had a significant effect size difference of 0.55 when compared to sham stimulation in the treatment of depression . A recent presentation [16] at the American Psychiatric Association's 2013 Annual Meeting, involving a multicentre, longitudinal, naturalistic, observational study, confirmed that acute rTMS induced " statistically and clinically meaningful response and remission " in patients with major depressive disorder during the acute phase, but more importantly that the results were maintained at 52 weeks. One advantage of rTMS over ECT is that the patient does not need anaesthesia, as well as the fact that seizures need not be induced. "
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    ABSTRACT: Electroconvulsive therapy (ECT) is the longest standing psychiatric treatment available and has unequivocal benefit in severe depression. However this treatment comes with a number of side effects such as memory impairment. On the other hand, Repetitive Transcranial Magnetic Stimulation (rTMS) is a relatively new form of treatment which has been shown to be efficacious in patients suffering from a number of psychopathologies, including severe depression, with few reported side effects. Due to its potential therapeutic efficacy and lack of side effects, rTMS has gained traction in the treatment of depression, with a number of authors keen to see it take over from ECT. However, it is not clear whether rTMS represents a therapeutic alternative to ECT. This meta-analysis will therefore compare the “gold standard” treatment for severe depression, with the relatively new but promising rTMS. A literature search will be performed with the intention to include all randomised clinical trials. The null hypothesis is that there is no difference in the antidepressant efficacy between the two types of treatment modalities. Statistical analysis of Hamilton Depression Rating Scale (HDRS) scores will be performed.
    Full-text · Article · Jul 2014 · Depression research and treatment
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    • "The first such device, Neuronetics' NeuroStar Ò , became commercially available in 2008 following pivotal trials demonstrating efficacy and safety for stimulation of the left prefrontal cortex with a fixed set of parameters and use of a simple fixed-distance measurement to determine coil placement on the patient's head [2] [3]. Recent data on naturalistic outcomes since the NeuroStar device has been incorporated into real-life clinical practices confirms efficacy and safety of rTMS delivery with this device [4]. A second device (Brainsway " Deep " TMS System) was FDA cleared for the treatment of depression in early 2013 [5]. "
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    ABSTRACT: Vagus nerve stimulation (VNS) and repetitive transcranial stimulation (rTMS) devices are FDA cleared for therapeutic use in treatment resistant depression. Since VNS systems have ferromagnetic components and large-scale safety testing has not been done, the implanted VNS device is considered a contraindication for rTMS therapy. This contraindication should not be considered absolute, as VNS components typically lie outside the electromagnetic field generated by an rTMS treatment coil. We solicited information from clinicians at several academic medical centers through an informal survey about their use of rTMS for depressed patients with implanted VNS systems, and reviewed relevant safety issues with one rTMS device manufacturer. rTMS clinical practices may use special consent procedures and take additional precautions to enhance safety in these situations. Specific recommendations are provided for minimizing risks (heating or movement of VNS components and unintended change in VNS stimulation parameters) when delivering rTMS to patients with implanted VNS systems.
    Full-text · Article · Jul 2014 · Brain Stimulation
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