Transcranial magnetic stimulation (TMS) involves placement of a small coil over the scalp through which a rapidly alternating current, producing a magnetic field, is passed unimpeded through the cranium and scalp. This document addresses TMS as a treatment of behavioral health indications including depression and other neuropsychiatric disorders.

Note: Please see the following related documents for additional information:

• MED.00108 Transcranial Magnetic Stimulation for Non-Behavioral Health Indications
• SURG.00007 Vagus Nerve Stimulation

Investigational and Not Medically Necessary:

Transcranial magnetic stimulation of the brain is considered investigational and not medically necessary for all behavioral health indications including, but not limited to, treatment of depression and all other neuropsychiatric disorders (e.g., anxiety disorders, mood disorders, schizophrenia).

TMS as Treatment for Depression and Treatment-Resistant Depression (TRD)

Medical literature on the use of TMS in the treatment of depression emphasizes the use of the intervention for TRD. The peer-reviewed medical literature on TMS for TRD (variably defined) includes a number of double-blind randomized sham-controlled short-term trials. Trial results show statistically significant improvement with active treatment, suggesting a response rate two to three times sham controls. Approximately 15% to 25% of the active treatment population in these trials showed a response although differences in study definitions for trial inclusion and prior treatment heterogeneity within each sample make comparison between the studies tenuous. Characteristics of individuals most likely to benefit are unknown. Variation in magnet placement, stimulus parameters and treatment trial duration indicate uncertainty about the appropriate clinical approach to TMS administration. Treatment protocols are time intensive. The role, if any, of concurrent antidepressant medication during TMS administration is uncertain. TMS does not appear to give as robust of a treatment response as electroconvulsive therapy (ECT). Durability of TMS response is unclear and optimal approach to sustaining any benefit achieved is unknown. Additional research is needed to determine the benefits of TMS relative to other alternatives such as a new antidepressant trial, antidepressant augmentation trial (e.g., with quetiapine or aripiprazole) or a trial of psychotherapy.

A number of meta-analyses include studies that vary with respect to the anatomic location of treatment, treatment intensity, stimulation frequency, pulses per session, and the total number of administered sessions of TMS. Five of the published meta-analyses of TMS treatment for depression vary in the selection criteria and analytic technique (Couturier, 2005; Gross, 2007; Lam, 2008; Martin, 2003; Schutter, 2009). The principal outcomes of these meta-analyses assess the clinical endpoints at the conclusion of TMS treatment only (i.e., one to four weeks). Four of the five meta-analyses found statistically significant depression scores between TMS and sham when analyzing the main set of studies. One meta-analysis did not find a statistically significant difference, but included only six studies of 88 participants with strict participant selection criteria (Couturier, 2005). Three of the meta-analyses (Gross, 2007; Lam, 2008; Martin, 2003) summarized the individual studies using the standardized mean difference (SMD), which allowed for pooling together studies with different outcome assessment methods, but did not allow for ease of presentation of measures of clinical response and remission. Only the meta-analyses by Martin (2003) and Lam (2008) analyzed any outcomes beyond the acute treatment period; however, there were few such studies included in these two meta-analyses. Additional studies in these meta-analyses are divided by key differences in treatment protocols; specifically, high frequency left dorsolateral prefrontal cortex (DLPFC) stimulation, low frequency (1-2 Hertz) stimulation of the right DLPFC, or combined high frequency and low frequency stimulation. Another significant limitation of these meta-analyses 9 was the lack of an antidepressant control group when comparing active TMS to a sham TMS control group for the treatment of depression. The studies included vary with regard to the use of concurrent antidepressant therapy. In the meta-analysis by Lam and colleagues (2008), most of the studies managed participants on the same medications, where some studies kept participants off all medications for a limited time or for the entire duration of treatment. Few studies initiated treatment concurrent with the initiation of TMS. None of the meta-analyses considered this variation in the use of medication in subgroup or the meta-regression analyses.

The earliest meta-analysis of 16 published clinical trials by Martin and colleagues (2003) concluded there was no strong evidence of benefit with the use of TMS for the treatment of depression, citing no difference between TMS and sham TMS. This review also found ECT was more effective than TMS.

Gross and colleagues (2007) conducted a systematic review and meta-analysis of five TMS studies on depression. The results were compared to the earlier meta-analysis by Martin and colleagues (2003) in order to determine whether more recent studies of TMS on depression utilizing updated treatment parameters demonstrated an improvement in clinical results. Inclusion criteria for studies were similar to those in the Martin (2003) meta-analysis and also involved: (1) mood effects assessed by a continuous mood scale, Hamilton Depression Rating (HAM-D) scale, Montgomery-Åsbery Depression Rating Scale (MADRS), Beck Depression Inventory (BDI); and (2) reporting of mood scores before and after treatment. The authors (Gross, 2007) noted that the studies examined in their meta-analysis were of "higher quality" than those reviewed in the meta-analysis by Martin and colleagues. The pooled effect size (SMD between pre-treatment vs. post-treatment) from the random effects model was of -0.76. This effect size is significantly greater (p<0.001) than that reported by Martin and colleagues, suggesting that the revised treatment parameters used in the more recent trials have improved the clinical results of TMS treatment for depression. However, the majority of studies reviewed were single-blinded and failed to find evidence of an enduring treatment effect after the initial response to TMS therapy.

Lam and colleagues (2008) conducted a meta-analysis that included the results of a number of double-blind, randomized, sham-controlled short-term trials using TMS for treatment-resistant depression (TRD). Slight improvements of uncertain clinical significance were reported across groups as a whole. The percentage of participants who showed a clinically significant response was reported at about two to three times that of sham controls, with around 15% to 25% of participants responding, and a number-needed-to-treat of six. For individuals with TRD, TMS appeared to provide significant benefits in short-term treatment studies. However, the relatively low response and remission rates, the short duration of treatment, and the relative lack of systematic follow-up studies suggested that further studies are needed before TMS can be considered as first-line monotherapy treatment for TRD.

Schutter (2009) conducted the largest and most recent meta-analysis including 30 double-blind randomized sham-controlled trials (n=1164) of high frequency TMS over the left DLPFC in individuals with major depression. This meta-analysis included three trials (Herwig, 2007; Koerselman, 2004; Rumi, 2005) of TMS as a primary/adjunctive treatment for depression that enrolled more than 40 subjects (27% of the participants). The analysis reported an overall weighted mean effect size for treatment (calculated with an SMD that adjusted for sampling variance) at 0.39, which was considered moderate. The meta-analysis also included the largest clinical trial of TMS by O'Reardon and colleagues (2007), which contributed to over one-fourth of the total number of participants; this trial was the basis for the U.S. Food and Drug Administration's (FDA) decision to clear TMS for marketing. Participants who enrolled in this trial had uncomplicated major depression meeting severity criteria and were required to have failed at least one but no more than four adequate antidepressant treatments in the current or most recent episode of depression. The design of the trial allowed unblinding and cross-over after four weeks for nonresponders. After four weeks of treatment with active or sham TMS, if the participant showed no or minimal improvement in depression symptoms, they were allowed to cross-over to an open-label, acute treatment-extension study. A large number of participants dropped out after four weeks to enter the open-label trial (Avery, 2008), thus, many of the six-week observation values in the trial reflected four-week values. The TMS participants improved 5.6 points on the MADRS compared to the sham group improvement of 3.5 points, leading to a mean difference of 2.1 points which was not statistically significant (p=0.057). The six-week results for all outcomes, all which consistently showed greater efficacy of TMS than at the four-week time point are based on 49% (148/301) values imputed from prior visits. The analyses of the six-week results are viewed with caution due to the inconsistent methods of analysis (i.e. using multiple methods for imputing missing values rather than last-observation-carried-forward) to determine the durability and effectiveness of retreatment with TMS. In addition, individuals in whom TMS is indicated are usually treated with a second course of antidepressant therapy. An important limitation in the O'Reardon clinical trial, which was sham controlled without active treatment (and the indication for which TMS received FDA-approval, i.e. one prior failure of an adequate antidepressant course), is that the results cannot rigorously determine whether TMS would be more or less effective than the standard treatment of a second course of antidepressant therapy.

Additional randomized studies, including a study of 60 individuals with TRD, compared the use of high- or low-frequency magnetic stimulation or sham stimulation over a period of four weeks (Fitzgerald, 2003). The primary outcome was changes in the MADRS. Both treatment groups reported significantly improved outcomes compared to the control group. Grunhaus and colleagues (2003) compared the outcomes of ECT and magnetic stimulation in 40 individuals with nonpsychotic major depression. Participants were treated over the course of a month (20 total sessions) and evaluated with the HAM-D scale, where a response was defined as a 50% decrease with a final score of less than or equal to 10. There was no difference in response rate between the two groups; 12 of 20 responded in the ECT group compared to 11 of 20 in the magnetic stimulation group. Other studies and meta-analyses focusing on TMS as a treatment of depression and other mood disorders found no or modest clinically significant differences between TMS and sham TMS treatment (Hasey, 2001; Holtzheimer, 2001; Hoppner, 2003; Loo, 2003). Studies comparing ECT to TMS found that response rates and relapse rates for depression were comparable or that ECT was more effective (Janicak, 2002). Subsequent randomized controlled trials were identified that compared the efficacy of TMS with sham controls as primary or adjuvant therapy for depression (Avery, 2006; Fitzgerald, 2006; Isenberg, 2005; Ray, 2011; Rossini, 2005). Some of these studies focused on TRD and two studies assessed whether TMS hastened the initial response to antidepressant treatment. The studies also examined the optimum frequency and location (left prefrontal, right prefrontal, or combined), intensity (percent of motor threshold), and duration of treatment for remission and maintenance. In addition, standardized treatment parameters have not been established. A subsequent open labeled extension of the sham controlled trial (Avery, 2008) showed that 44.7%-45.9% of those who received sham treatment initially responded and 30.6%-36.5% achieved remission after six weeks of rTMS followed by three weeks of taper. Of those who failed to improve with initial rTMS, another 31.5%-34.2% responded, while only 9.2%-17.8% achieved remission after the second trial.

Randomized controlled trials of varying size and design have subsequently been published in the peer-reviewed medical literature. In a small prospective, randomized, hospital-based sham-controlled study (n=41) by Ray and colleagues (2011), 75% of individuals who received daily sessions of active TMS over the right DLPFC for 10 days achieved remission as compared to 10% in the control group. This study included individuals with psychotic depression. Triggs and colleagues (2010) published a small prospective, randomized, sham-controlled, double-blind parallel group study (n=48) involving both right and left-sided TMS for medication-resistant depression. A total of 45 participants completed the three-month follow-up time beyond the end of treatment. Right cranial stimulation was reported as significantly more effective than left cranial stimulation (sham or TMS, p=0.012); however, overall reductions in HAM-D-24 from baseline to ten weeks beyond the treatment period were not statistically different between the TMS and sham treatment groups.

A second prospective, multicenter, randomized, sham-controlled trial reported results using daily prefrontal TMS on 199 participants with a moderate level of antidepressant drug-free, unipolar major depressive disorder (MDD) (George, 2010). The trial used the same device as the FDA-approved NeuroStar^® TMS (Neuronetics, Malvern, PA) device and a similar participant selection and treatment protocol. Of note, participants underwent head magnetic resonance imaging (MRI) to refine the location of the magnetic coil used to administer TMS; relocation of the coil occurred in 33.2% of participants. Subjects received treatment for a variable period of three to six weeks. Lack of improvement in the first three weeks (classified as treatment failures) led to discontinuation from Phase 1 of the clinical trial and cross-over to open treatment in Phase 2 of the trial. Partial responders in the first three weeks continued with sham or TMS. At the variable end point of the study, the response rate using an intention-to-treat (ITT) analysis for remitters (n=18) was 14.1% in the active TMS group and 5.1% in the sham group (p=0.02). Most remitters had low antidepressant treatment resistance. Results were similar for response to treatment outcomes, 15.5% in the active TMS group versus 5% in the sham group. Comparing participants receiving active TMS to sham TMS, active TMS participants demonstrated significantly greater improvement in mean scores for the MADRS, Clinical Global Impression Improvement Scale (CGI-S), and Inventory of Depressive Symptoms-Self Rated (IDS-SR) but not the HAM-D-24. A significant limitation of this trial was the failure to enroll the projected 240 participants as suggested by the initial power analysis, due in part to the delayed start of the trial as a result of extensive work in designing a sham system. According to the investigators, "This power issue may be the reason why the treatment condition effect on remission rate in the fully adherent sample analysis was not statistically significant. Treaters were able to guess randomization assignment better than chance, without much confidence, which was not explained by covarying for clinical benefit. It may be that there were some other physical changes during treatment that these physicians were able to detect, although the sham effectively reduced differences in sound, facial twitch, and patient pain." Nine participants were excluded from the ITT analysis due to entering the study prior to refining the sham treatment coil or exiting prior to treatment (n=7 and 2, respectively). Of the remaining 190 participants, there were 11 dropouts (12%) in the active TMS ITT group and 9 dropouts (9%) in the sham ITT group. Finally, the long term clinical benefits of treatment are unclear with the overall limited number of remitters and responders in a study designed to require daily TMS treatment for three weeks or more.   

Janicak and colleagues (2010) reported on assessment of relapse of MDD during a longer term observational study of various groups of responders in two trials described in an FDA Executive Summary concerning the NeuroStar^® TMS System (FDA, 2007). Participants that ultimately responded to active TMS or sham in the original randomized controlled trial, or responded to active TMS in the open label extension were followed for recurrence of depression and/or need for reintroduction of active TMS over a 24-week treatment period. Relapse was the primary outcome measure, defined as a recurrence of DSM-IV criteria for major depression or failure to achieve symptom improvement upon reintroduction of TMS. Ten of 99 (10%) participants relapsed, 38 (38.4%) participants had worsening symptoms, and 32 of the 38 participants (84%) achieved symptomatic benefit with adjunctive TMS. It is difficult to draw conclusions from this data regarding the treatment effect of TMS. All the study participants had initiated antidepressants, making it difficult to attribute the duration of response to TMS alone. The participants in the control group in this clinical trial only received sham TMS. Although participants who initially responded to sham had higher relapse and TMS re-treatment rates, the numbers are too small for statistically meaningful comparisons, and the groups may not be comparable. Additional data are needed to determine the durability of the treatment effect, particularly in maintenance phases.

Pallanti and colleagues (2010) conducted a three-group, three week, double-blind randomized controlled trial (n=60) comparing unilateral low frequency to sequential bilateral TMS treatment and sham over the right DLPFC in individuals with TRD under stable antidepressant management. Participants were assigned to receive either low-frequency TMS followed by contralateral sham (unilateral group, n=20), low frequency right DLPFC TMS followed by left DLPFC high frequency TMS (bilateral group, n=20), or bilateral sham (sham group, n=20). The primary outcome measure was response to treatment based on HAM-D score. Low frequency right-sided and sequential bilateral stimulation showed different antidepressant efficacy at three weeks and across the full duration of the study, only the unilateral method appearing significantly more effective than sham at the end of the trial; these results correlated to the higher percent of remitters (30% of the group versus 10% -bilateral- and 5% -sham). The study results indicate that the efficacy of unilateral TMS and bilateral TMS are not similar; only unilateral condition showed significant higher antidepressant effect than sham in individuals with severe TRD. According to the article, the results do not support the hypothesis of an additive effect of sequential bilateral stimulation when compared to unilateral stimulation. The investigators concluded that the data suggests that right-sided low frequency stimulation may be a first-line treatment alternative for TRD; however, further studies require a longer follow-up period.

The largest and most recent meta-analysis by Slotema and colleagues (2010) evaluated the efficacy of TMS for various psychiatric disorders. Data were obtained from randomized, double-blind, sham-controlled trials of TMS treatment for depression (34 studies, 1383 participants). Studies of TMS versus ECT (six studies) for depression were meta-analyzed. The 2007 clinical trial by O'Reardon and colleagues is included in this meta-analysis. The analysis had very broad selection criteria for inclusion, allowing any type of TMS treatment and any type of depression experienced by the study participants. Participants were free of antidepressant agents (i.e., TMS monotherapy) in seven studies, antidepressants were continued in 17 studies, and antidepressants were initiated along with TMS in five studies. The mean weighted effect size of TMS versus sham for depression was 0.55 (p<0.001). ECT therapy was superior to TMS in the treatment of depression (mean weighted effect size of 0.54 (p<0.001). Subgroup analyses comparing TMS as a monotherapy versus continuation or initiation of antidepressants showed that the mean weighted effect size for TMS monotherapy (effect size 0.96, p<0.001), trended toward having a stronger treatment effect than for TMS with continuation of antidepressants (effect size 0.51, p<0.001) or TMS with initiation of antidepressants (effect size 0.37, p=0.03). This analysis, however, should not be interpreted to mean that TMS monotherapy is possibly more effective than as used with antidepressants, but that the treatment difference between TMS and the corresponding control group for each type of study is larger for TMS monotherapy versus a no-treatment sham-only control group. According to the authors, "[a]lthough the efficacy of rTMS in the treatment of depression…may be considered proven, the duration of the effect is as yet unknown. Effect sizes were measured immediately after the cessation of rTMS treatment. There are indications that the effects of rTMS may last for several weeks to months. Further studies should assess symptom relief with longer follow-up periods to assess the cost-effectiveness of rTMS treatment, and to indicate its economic advantages and disadvantages." "Although rTMS cannot replace ECT in depressive patients, there may be subgroups in which rTMS can replace antidepressant medication."

TMS as Treatment for Depression in the Elderly

Two small randomized, double-blind, sham-controlled trials examined TMS for depression in elderly individuals (mean age greater than 60 years) (Manes, 2001; Mosimann, 2004). Repetitive TMS was an adjunctive treatment in the Mosimann study and monotherapy for depression in the Manes study. Stimulation intensity varied slightly between these studies (80% or 100% MT). Only five sessions of TMS were administered in the Manes study, considerably less than the 10 to 30 sessions given in most other studies reviewed in this report. Response rates in the TMS group were comparable with those of the sham group in both studies, and remission rates were also similar when this measure was reported (Manes). These results suggested that TMS was not an effective treatment (adjunctive or monotherapy) for depression in elderly individuals. Limitations of these studies were the small sample size and inclusion of individuals with a range of depression severity (minor or major). Jorge and colleagues (2008) reported the results of a modestly powered (n=92) randomized sham-controlled trial of complicated design (two stimulus sets used) using TMS to treat vascular depression (VD), a term used to describe late-life depressive disorders in individuals with clinical evidence of cerebrovascular disease. Preliminary data on these elderly, post-stroke individuals with depression suggests that they may benefit from TMS, but it appears to become a less effective treatment for depression in the elderly as the population ages.

Additional Pertinent Information

The American Academy of Neurology (AAN) (Miyasaki, 2006) evidence-based practice parameter for the evaluation and treatment of depression, psychosis, and dementia has concluded there is insufficient evidence to support or refute the efficacy of TMS or ECT in the treatment of depression associated with Parkinson disease.

In a randomized clinical trial conducted for the National Coordinating Centre for Health Technology Assessment (NCCHTA), McLoughlin and colleagues (2007) randomized 46 individuals with major depression to receive a 15-day course of TMS (n=24) or a course of ECT (n=22). One participant was lost to follow-up at the end of treatment; nine participants were lost to follow-up at six months. The end-of-treatment HAM-D scores were lower for ECT (95% confidence interval [CI] 3.40 to 14.05, p = 0.002), with 13 (59%) achieving remission compared with four (17%) in the TMS group (p=0.005). However, HAM-D scores did not differ between groups at six months. Beck Depression Inventory-II (BDI-II), visual analogue mood scales (VAMS), and Brief Psychiatric Rating Scale (BPRS) scores were lower for electroconvulsive therapy at end of treatment and remained lower after six months. Improvement in subjective reports of side-effects following ECT correlated with antidepressant response. There was no difference between the two groups before or after treatment on global measures of cognition and no difference in gain in quality adjusted life years (QALYs) for ECT or TMS participants. The investigators concluded that ECT is a more effective antidepressant treatment than three weeks of TMS. Optimal treatment parameters for TMS need to be established for treating depression. There is, however, a need for large-scale, adequately powered randomized controlled trials of TMS that compare treatment variables such as stimulus intensity, number of stimuli administered and duration of treatment, with a view to quantifying an effect size for antidepressant action.

A work group of the American Psychiatric Association (APA) has published the third edition of the Practice Guideline for the Treatment of Patients with Major Depressive Disorder (Gelenberg/APA, 2010). According to the work group, "A substantial number of studies of TMS have been conducted, but most have had small sample sizes, and the studies overall have yielded heterogeneous results. Further complicating the interpretation of the TMS literature is the variability in stimulation intensities (relative to the motor threshold), stimulus parameters (e.g., pulses/second, pulses/session), anatomical localization of stimulation, and number of TMS sessions in the treatment course." The guideline reviews the available evidence for TMS including the largest randomized, double-blind, multisite study that accompanied the FDA clearance of the TMS device (O'Reardon, 2007) and numerous meta-analyses of studies previously discussed within this document. As an initial treatment modality, the guideline recommends:   

Treatment in the acute phase should be aimed at inducing remission of the major depressive episode and achieving a full return to the patient's baseline level of functioning. Acute phase treatment may include pharmacotherapy, depression-focused psychotherapy, the combination of medications and psychotherapy, or other somatic therapies such as electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or light therapy. In comparisons of actual TMS versus sham TMS, most but not all recent meta-analyses have found relatively small to moderate benefits of TMS in terms of clinical response. Although the primary studies used in these meta-analyses are highly overlapping and the variability in TMS stimulus parameters and treatment paradigms complicates the interpretation of research findings, these meta-analyses also support the use of high-frequency TMS over the left dorsolateral prefrontal cortex. Lesser degrees of treatment resistance may be associated with a better acute response to TMS (Lisanby, 2009). In comparison with ECT, TMS has been found in randomized studies to be either less effective than ECT (Eranti, 2007) or comparable in efficacy to ECT (Grunhaus, 2003; Janicak, 2002; Rosa, 2006), but in the latter studies TMS was more effective and ECT was less effective than is typically seen in clinical trials.

As a strategy to address changing to other treatments for individuals who do not respond adequately to pharmacotherapy after allowing sufficient time between medications to avoid hazardous interactions, the guideline states that TMS "could also be considered" (Level II: Recommended with moderate clinical confidence). "TMS could also be an option, as it appears to be safe and well tolerated. In addition, it has shown small to moderate benefits in most but not all (Couturier, 2005; Herwig, 2007) clinical trials and recent meta-analyses." However, when comparing TMS to other somatic therapies such as ECT and vagus nerve stimulation (VNS), the guideline states, "ECT is recommended as a treatment of choice for patients with severe major depressive disorder that is not responsive to psychotherapeutic and/or pharmacological interventions, particularly in those who have significant functional impairment or have not responded to numerous medication trials" (Level I: Recommended with substantial clinical confidence) (Gelenberg/APA, 2010).

The Institute for Clinical Systems Improvement's (ICSI, 2011) health care guideline titled Major Depression in Adults in Primary Care discusses TMS as a treatment for MDD that fails to respond to at least one antidepressant trial during the current illness episode. In addition, the guideline states "While many studies have been conducted, results are heterogeneous, likely due to small sample sizes and significant variability of anatomical localizations and stimulation intensities and parameters. Consequently, rTMS is not a first-line treatment, and there is ongoing lack of clarity about which patient populations should be targeted."

TMS as Treatment for Other Neuropsychiatric Disorders

A number of studies and meta-analyses explore the efficacy of TMS for a selection of neuropsychiatric-related disorders including the treatment of auditory verbal hallucinations (AVH) in schizophrenia and other conditions (Blumberger, 2010; Burt, 2002; Cordes, 2010; Dlabac-de, 2010; Freitas, 2009; Hoffman, 2000; Hoffman, 2002; Hoffman, 2003; Klein, 1999; Loo, 2010; Matheson, 2010; Rollnik, 2000; Slotema, 2010; Slotema, 2011; Tranulis, 2008), bulimic eating disorders and addictions (Van den Eynde, 2010; Walpoth, 2008), cravings in alcohol dependence syndrome (Mishra, 2010), mood status post stroke (Kim, 2010), obsessive-compulsive disorder (OCD) (Alonso, 2001; Greenberg, 1997; Kang, 2009; Mantovani, 2006; Mantovani, 2010; Martin, 2003; Sachdev, 2007; Slotema, 2010), panic disorders (Prasko, 2007), and post-traumatic stress disorder (PTSD) (Boggio, 2010; Cohen, 2004; Osuch, 2009). Methodological limitations of these studies include small sample size, absence of a placebo control group, presence of concurrent pharmacotherapy, and lack of long-term outcomes. The durability of this treatment and its role in the treatment of other neuropsychiatric disorders is unknown.

The American Psychiatric Association has practice guidelines that address the use of rTMS in individuals with auditory hallucinations in schizophrenia and OCD. For individuals with hallucinations in schizophrenia, the practice guideline states "although it has been suggested that repetitive transcranial magnetic stimulation (rTMS) may share beneficial features of ECT and several studies with rTMS have shown promising results in decreasing auditory hallucinations, rTMS does not have an FDA indication for the treatment of psychosis, and additional research is needed before recommending its use in clinical practice" (Lehman/APA, 2004). A subsequent Guideline Watch issued in September 2009 offers no updated recommendations to the 2004 guideline. The APA practice guideline for treatment of OCD evaluated four trials of rTMS, reporting results as "inconsistent, perhaps because the studies differed in design, stimulation sites, duration, and stimulation parameters. The available results and the technique's non-invasiveness and good tolerability should encourage future research, but the need for daily treatment may limit the use of TMS in practice" (Koran/APA, 2007).

Epidemiology

Behavioral health disorders are common in the general population in the United States. According to the National Institute of Mental Health (NIMH, 2010) an estimated 26.2 percent of Americans ages 18 and older - about one in four adults - suffer from a diagnosable mental disorder in a given year. The occurrence of mood disorders, including major depressive disorder, dysthymic disorder, and bipolar disorder, affects approximately 20.9 million American adults, or about 9.5 percent of the U.S. population age 18 and older in a given year. Other conditions such as anxiety disorders, including generalized anxiety disorder, OCD, panic disorder, phobias, and PTSD affect approximately 40 million U.S. adults ages 18 and older, or about 18% in this age group in a given year. Individuals who suffer from depression may experience functional impairment, increased risk of suicide, higher health care expenses and losses in productivity. Complaints of sleep disturbance, fatigue and pain are the most common presentations of depression. Treatment in the acute phase of a major depressive episode may include pharmacotherapy, depression-focused psychotherapy (i.e. "talk therapy"), and the combination of medications and psychotherapy, or other somatic therapies such as ECT, recommended as the treatment of choice for individuals with severe major depression not responsive to psychotherapeutic and/or pharmacological interventions.

Functional Description

Transcranial magnetic stimulation (TMS) was first introduced in 1985 as a method of noninvasive stimulation of the brain. The technique involves placement of a small coil over the scalp; a rapidly alternating current is passed through the coil wire, producing a magnetic field that passes unimpeded through the cranium and scalp. TMS was initially used to investigate nerve conduction. For example, TMS over the motor cortex of the brain produced a muscle-evoked response on the opposite side. Interest in the use of TMS as a treatment for depression was prompted by the development of a device that could deliver rapid, repetitive stimulation (rTMS).

In contrast to ECT, TMS does not require anesthesia, and does not induce a convulsion. Early studies suggested that TMS of the left prefrontal cortex was associated with antidepressant properties. The device utilized for this procedure has been studied as a treatment for other behavioral health and neuropsychiatric disorders including auditory hallucinations in schizophrenia, OCD, and PTSD.

Devices for transcranial stimulation have received FDA approval for diagnostic uses. In January 2007, an FDA advisory panel met to determine if the risk to benefit profile for the NeoPulse device was comparable to the risk to benefit profile of predicate ECT devices. The FDA advisory panel was not asked for a recommendation regarding the regulatory determination of substantial equivalence with this 510(k) submission. The Neopulse device, now known as the NeuroStar^® TMS (Neuronetics, Malvern, PA), received clearance for marketing as a Class II repetitive transcranial magnetic stimulator device in October 2008. NeuroStar^® TMS Therapy is indicated for the treatment of adults with "major depressive disorder who have failed to achieve satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the episode" (FDA, October 2008). On December 16, 2008 the FDA determined the NeuroStar^® TMS Therapy System was a substantially equivalent device to the legally marketed predicate device, therefore, granting 510(k) marketing approval as a Class II "repetitive transcranial magnetic stimulator for treatment of major depressive disorder" (FDA, December 2008).

The major adverse effects of TMS are headache and pain or discomfort at the site of application of the device. In a study reported by Janicak and colleagues (2008), aggregate safety data were obtained from a comprehensive clinical development program examining the use of TMS in the treatment of major depressive disorder. There were three separate clinical protocols, including 325 individuals from 23 clinical sites in the United States, Australia, and Canada. The authors reported that TMS was associated with a low incidence of adverse events that were mild to moderate in intensity and demonstrated a largely predictable time course of resolution.

Beck Depression Inventory (BDI): A twenty-one question multiple choice self-report inventory that is one of the most widely used instruments for measuring the severity of depression.

Depression: A state of depressed mood characterized by feelings of sadness, despair and discouragement.

Dysthymia: A type of depression involving long-term, chronic symptoms that does not disable a person but inhibits their ability to function at a high level or to feel well.

Hamilton Depression (HAM-D) Rating Scale: A twenty-question multiple-choice questionnaire used to rate the severity of an individual's depression.

Major depression: A combination of symptoms (e.g., overwhelming sadness, anxiety, or "empty" feelings, hopelessness and pessimism, trouble making decisions, remembering, and concentrating) that are disabling and makes daily functioning extremely difficult if not impossible.

Montgomery-Åsbery Depression Rating Scale (MADRS): A frequently used observer-rated depression scale.

Schizophrenia: A disorder or group of disorders characterized by disturbances in form and content of thought, mood, sense of self, and relationship to the external world.

Transcranial magnetic stimulation (TMS): Involves placement of a small coil over the scalp through which a rapidly alternating current, producing a magnetic field, is passed unimpeded through the cranium and scalp.

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Peer Reviewed Publications:

1. Alonso P, Pujol J, Cardoner N, et al. Right prefrontal transcranial magnetic stimulation for obsessive-compulsive disorder: a preliminary investigation. J Clin Psychiatry. 2001; 62:981-984.
2. Avery DH, Holtzheimer PE III, Fawaz W, et al. A controlled study of repetitive transcranial magnetic stimulation in medication-resistant major depression. Biol Psychiatry. 2006; 59(2):187-194.
3. Avery DH, Isenberg KE, Sampson SM, et al. Transcranial magnetic stimulation in the acute treatment of major depressive disorder: clinical response in an open-label extension trial. J Clin Psychiatry. 2008; 69:441-451.
4. Blumberger DM, Fitzgerald PB, Mulsant BH, Daskalakis ZJ. Repetitive transcranial magnetic stimulation for refractory symptoms in schizophrenia. Curr Opin Psychiatry. 2010; 23(2):85-90.
5. Boggio PS, Rocha M, Oliveira MO, et al. Noninvasive brain stimulation with high-frequency and low-intensity repetitive transcranial magnetic stimulation treatment for posttraumatic stress disorder. J  Clin Psychiatry. 2010; 71(8):992-999.
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Government Agency, Medical Society, and Other Authoritative Publications:

1. Belmaker B, Fitzgerald P, George M, et al. International Society for Transcranial Stimulation Consensus Statement. Managing the risks of repetitive transcranial stimulation. CNS Spectrums. 2003; 8(7):482.
2. Gelenberg AJ, Freeman MP, Markowitz JC, et al. American Psychiatric Association (APA). Practice guideline for the treatment of patients with major depressive disorder. 3^rd Edition. (October 2010). Available at: http://www.psych.org/guidelines/mdd2010. Accessed on June 9, 2011.
3. Institute for Clinical Systems Improvement (ICSI). Health care guideline: Major depression in adults in primary care. 14^th Edition. (May 2011). Available at: http://www.icsi.org/depression_5/depression__major__in_adults_in_primary_care_3.html. Accessed on June 9, 2011.
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5. Lehman AF, Lieberman JA, Dixon LB, et al. American Psychiatric Association (APA). Practice guideline for the treatment of patients with schizophrenia. 2^nd Edition. Am J Psychiatry. 2004; 161(2 Suppl):1-56.
6. Martin JL, Barbanoj MJ, Pérez V, Sacristán M. Transcranial magnetic stimulation for the treatment of obsessive-compulsive disorder. Cochrane Database Syst Rev. 2003; (3):CD003387.
7. Miyasaki JM, Shannon K, Voon V, et al. Practice parameter. Evaluation and treatment of depression, psychosis, and dementia in Parkinson disease (an evidence-based review). Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2006; 66(7):996-1002.
8. U.S. Food and Drug Administration (FDA). 510(k) Premarket Notification Database. NeuroStar^® TMS Therapy System. No. K083538. Rockville, MD: FDA. December 16, 2008. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf8/K083538.pdf. Accessed on June 9, 2011.
9. U.S. Food and Drug Administration (FDA). Advisory Committees. Brief Summary from the Neurological Devices Panel Meeting. January 26, 2008. Available at: http://www.fda.gov/cdrh/panel/summary/neuro-012607.html. Accessed on June 9, 2011.
10. U.S. Food and Drug Administration (FDA). FDA Executive Summary. Neurological Devices Panel of the Medical Devices Advisory Committee. January 26, 2007. Available at: http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4273b1_01-FDAExecutiveSummary.pdf. Accessed on June 9, 2011.
11. U.S. National Institutes of Health (NIH). Transcranial magnetic stimulation: multiple clinical trials. Available at: http://www.clinicaltrials.gov/ct/search?term=transcranial+magnetic+stimulation. Accessed on June 9, 2011.

1. National Institute of Mental Health (NIMH). Statistics. Last reviewed July 29, 2010. Available at: http://www.nimh.nih.gov/health/topics/statistics/index.shtml. Accessed on June 9, 2011.

Beck Depression Inventory (BDI-BDI II)
Hamilton Depression Rating Scale (HAM-D)
Montgomery-Åsbery Depression Rating Scale (MADRS)
NeuroStar^® TMS Therapy
Repetitive Transcranial Magnetic Stimulation (rTMS)
Transcranial Magnetic Stimulation (TMS)

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.