Repetitive/Conventional, Theta Burst and Deep Transcranial Magnetic Stimulation
Repetitive/Conventional Transcranial Magnetic Stimulation (rTMS) is a method of delivering electrical current to the brain. A magnetic field is generated by passing a rapidly alternating current through a coil placed over the scalp. This produces a magnetic field that passes unimpeded through the scalp and bone, resulting in electrical stimulation of the cortex. Transcranial magnetic stimulation has been investigated as a treatment for depression, schizophrenia, migraine headache, spinal cord injury, tinnitus, fibromyalgia and other conditions.
A variety of TMS modalities have been developed, which differ on parameters including stimulation intensity, frequency, pattern, and site of the brain stimulation. In conventional TMS, high frequency stimulation is delivered over the left dorsolateral prefrontal cortex (DLPFC) or low frequency stimulation over the right DLPFC. Theta burst stimulation is administered at lower intensities and at shorter intervals than conventional TMS and may be administered using an accelerated protocol. Deep TMS employs an H-coil helmet designed to encompass a broader surface area and stimulate deeper brain structures than conventional TMS.
Several devices for transcranial stimulation have received clearance from the U.S. Food and Drug Administration (FDA) for transcranial magnetic stimulation. The NeuroStar® TMS, Brainsway Deep TMS System, Rapid Therapy System, the MagVita Therapy System, and the NeuroSoft TMS have received marketing clearance for treatment of patients with major depressive disorder. The Cerena™ TMS device received marketing clearance for the acute treatment of pain associated with migraine headache with aura. Other devices cleared for marketing for the treatment of headache include the Spring TMS® and the sTMS Mini™.
Significant adverse events including tonic-clonic seizures are rare but have been associated with rTMS. Emergency equipment and seizure management planning is recommended. Other side effects include syncope, which may mimic seizure activity, induction of manic or hypomanic symptoms, and site discomfort..
Navigated Transcranial Magnetic Stimulation
Navigated transcranial magnetic stimulation (nTMS) is a noninvasive imaging method for the evaluation of brain areas. Transcranial magnetic pulses are delivered to the patient as a navigation system calculates the strength, location, and direction of the stimulating magnetic field. The locations of these pulses are registered to a magnetic resonance image of the patient’s brain. Navigated TMS is being evaluated as an alternative to other noninvasive cortical mapping techniques for presurgical identification of eloquent areas.
Definitions
Augmentation Trial: An augmentation trial involves the addition of a second drug to existing pharmacologic therapy to achieve a clinical response. In depression treatment, augmentation therapy may involve addition of second drug in the same class or a different class (see below).
Standardized Depression Ratings Scale: Accurate diagnoses and measures of outcome in behavioral health often rely on ratings scales. In the context of this policy, several scales have been standardized to reflect the Diagnostic and Statistical Manual of Mental Disorders (DSM) definition of a major depressive episode and have been assessed for clinical reliability and validity. Available standardized depression rating scales include but are not limited to the following:
Therapeutic Agent Classification: Drug class refers to agents with a similar chemical structure, mechanism of action, or pharmacological effects. Drug classes for treatment of depression include but are not limited to the following:
NOTE: Transcranial Magnetic Stimulation (TMS) criteria in sections I and II apply to the following modalities: conventional or repetitive rTMS, theta-burst TMS, and deep brain/deep TMS.
Transcranial Magnetic Stimulation
I. Transcranial magnetic stimulation may be considered MEDICALLY NECESSARY AND APPROPRIATE as a treatment of major depressive disorder when ALL of the following criteria have been met:
II. Transcranial magnetic stimulation (TMS) is considered EXPERIMENTAL/INVESTIGATIVE for all other uses including but not limited to the following due to a lack of evidence demonstrating an impact on health outcomes:
Navigated Transcranial Magnetic Stimulation
III. Navigated transcranial magnetic stimulation (nTMS) is considered EXPERIMENTAL/ INVESTIGATIVE for all indications due to a lack of evidence demonstrating an impact on health outcomes.
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No additional statements.
Summary of Evidence
TMS was first introduced as a similar but potentially more acceptable alternative to electroconvulsive therapy (ECT). Evaluation of TMS for treatment-resistant, major depressive disorder includes studies comparing TMS with sham as well as evidence when used as a replacement for or adjunct to pharmacotherapy that has not improved depressive symptoms and as an alternative to ECT. The percentage of subjects who show a clinically significant response is reported at approximately 2 to 3 times that of sham controls. Based on the short-midterm benefit observed in randomized controlled trials, clinical input, and the lack of alternative treatments aside from ECT in patients with treatment-resistant MDD, TMS may be considered medically necessary in patients who meet specific criteria.
Evaluation of TMS for a multitude of other conditions has limited or absent strong evidence to support use. Limited by available studies it is unknown if favorable outcomes found during treatment with TMS can consistently show durability of results and higher quality studies are being awaited. Despite the augmentation potential for the combination of ketamine and TMS therapy simultaneously, limited research has been completed to clarify its efficacy. There is insufficient data supporting adjunctive treatment of intranasal esketamine (Spravto) with TMS therapy.
The evidence fails to show navigated TMS (nTMS) test performance has high clinical validity based on variable sensitivity and positive and negative predictive values. There is limited evidence on the benefit of nTMS over the current gold standard for language and motor mapping, direct cortical stimulation mapping.
Rationale
Systematic reviews and randomized controlled trials evaluating the safety and efficacy of left dorsolateral prefrontal cortex repetitive transcranial magnetic stimulation (rTMS) for treatment-resistant, major depressive disorder in adults have been reported. Studies have compared TMS to electroconvulsive therapy (ECT) and TMS to sham Prospective case series and randomized control trials have also investigated TMS as a therapeutic option for treatment-resistant depression. Outcome measures varied and included the Clinical Global Impressions-Severity of Illness scale (CGSI), patient reported inventory of Depressive Symptoms Self Report (IDS-SR), 9-Item Patient Health Questionnaire (PHQ-9), Clinical Global Impressions-Severity of Illness Scale (CGI-S), Hamilton Depression Rating Scale (HDRS), Beck Depression Inventory-II, visual analogue mood scales (VAMS), and Brief Psychiatric Rating Scale. Reduction in depressive symptoms, suicide ideation and remission of depression. Although there are conflicting results, overall improvement or remission of symptoms of depression and/or suicidal tendencies following TMS have been reported, especially when TMS was compared to sham. Other studies reported better outcomes with ECT. However, some studies reported that response and remission rates following TMS were as good as ECT with fewer side effects. TMS adverse events, which were typically mild and transient, included headaches and localized discomfort/pain of the scalp during stimulation. In rare cases, seizures and psychotic symptoms were reported following TMS. Additional research is needed for peer-reviewed, published studies supporting TMS as a maintenance therapy and as a treatment option for young people less than age 18 years are lacking.
The first randomized, sham controlled multicenter trial reported by O’Reardon et al (2007). This was a global 23 site study that consisted of numerous phases such as one week, no treatment lead in, a four-to-six-week acute monotherapy of TMS treatment, and then a four to six week open-label trial for non-responders. This study concluded that in the patients that failed one prior medication trial there was a robust effect from TMS versus the sham group (p<0.001). The second sham controlled, randomized multicenter trial was conducted by the National Institutes of Mental Health as researched by George (2010). This eight-week study detailed a two-week lead-in phase, three-week fixed TMS treatment protocol phase and a three-week treatment extension phase. The results were summarized as “TMS as monotherapy produced significant and clinically meaningful antidepressant therapeutic effects greater than sham. The third review consisted of the Brainsway trial that involved 20 locations between the U.S., Canada, Europe, and Israel as researched by Levkovitz (2015). This fully blinded, randomized-active sham trial studied patients with MDD who had failed one to four pharmacological trials. The patients were given TMS in the acute four-week phase and followed with treatment for an additional 12 weeks. The total sample size was 703 patients. The results of this study demonstrated that 64%-90% of patients showed acute TMS durability benefits, and most of the patients relapsing had responded to more TMS treatments.
Matsuda et al (2023) examined repetitive transcranial magnetic stimulation for preventing relapse in antidepressant treatmentresistant depression by conducting a systematic review and meta-analysis of 3 randomized controlled trials with a total of 90 participants. The participants were adults diagnosed with treatment-resistant depression and not responsive to antidepressants. The control groups involved a placebo or treatment as usual with the intervention group receiving rTMS. In the 3 RCTs, rTMS did not outperform the control groups in all efficacy outcomes (p=0.188). The pooled results for the meta-analysis indicated that rTMS outperformed the control groups in relapse rates (p=0.028). In addition, rTMS was also slightly superior to the control on reducing the HAM-D score (p=0.059). The authors conclude that rTMS as a strategy for relapse prevention is not recommended at this time. A primary limitation is the small sample sizes rendering low statistical power. The authors recommend replication with future larger, high-quality, double-blind, randomized, sham-controlled trials on continuation rTMS for adults with a specific psychiatric disorder.
Valiengo et al (2022) systematically reviewed 14 RCTs for meta-analysis and 26 studies for meta-regression analysis. Study participants were receiving rTMS for MDD treatment and older than 50. A total of 1,028 participants received active (n=728) or sham (n=300) TMS at baseline. The primary outcome was outlined as reduction in depression severity scores after Transcranial Magnetic Stimulation Page 5 of 22 Optum Behavioral Clinical Policy Annual Review Date: 10/17/2023 Proprietary Information of Optum. Copyright 2024 Optum, Inc. rTMS or sham treatment, while secondary outcomes were defined as treatment response or remission rates. The Hamilton Depression Rating Scale (HDRS) was utilized as the scoring tool when possible. The meta-analysis of the primary outcome produced a medium effect size of 0.36 (95% CI = 0.13–0.6) across the 10 studies reporting these data, representing a statistically significant improvement in HDRS with active rTMS in comparison to sham. Significant results for secondary outcomes of treatment response were (OR = 3.26; 95% CI = 2.11–5.04) and remission rates (OR = 4.63; 95% CI = 2.24–9.55). The meta-regression analysis assessed the association of variables with the primary outcome; the results found that mean age (p = .02) and total number of sessions (p = .003), but not any of the remaining variables, were significantly associated with improvement in depression severity scores. The authors rated the reviewed studies as moderate to high quality. Limitations acknowledged by the authors include a low number of RCTs (n=14), methodological heterogeneity among the studies, and the average age was younger than 75 years in all studies, therefore, limiting the generalizability to those older than 75 years. The authors recommend future large, multi-site designs with a focus on the geriatric population to determine treatment protocols and durability data
Consensus recommendations for the application of repetitive transcranial magnetic stimulation (rTMS) were published in 2018 by the National Network of Depression Centers rTMS Task Group and the American Psychiatric Association Council on Research Task Force on Novel Biomarkers and Treatments . A total of 118 publications (including 3 RCTs) from 1990 through 2016 were included in the consensus statement and were supplemented with expert opinion to achieve consensus recommendations on key issues surrounding the administration of rTMS for major depressive disorder (MDD) in clinical practice settings. • This consensus recommendation document indicates the following:
Obsessive Compulsive Disorder
For individuals who have obsessive-compulsive disorder (OCD) who receive TMS, the evidence includes a number of small-to-moderate sized, sham-controlled, double-blind RCTs and meta-analyses of these studies. Relevant outcomes are symptoms, functional outcomes, and quality of life. A meta-analysis of 15 RCTs (N=483 patients, range 18 to 65 patients) conducted in 2016 found a benefit of TMS on patient reported OCD symptom severity at time points ranging from 2 to 6 weeks, but there was substantial variability in the stimulation parameters, including the cortical region that was stimulated and the frequency of stimulation. A meta-analysis conducted in 2021 included 26 RCTs. The primary analysis found a significant effect of TMS compared to sham on OCD symptoms, but the effect seemed to last only until 4 weeks after the last treatment. The RCT that was the basis of FDA clearance of deep TMS for treatment of OCD compared deep TMS to sham in 99 patients for 6 weeks, with an additional 4 weeks of follow-up as a secondary outcome. Using a modified intention-to-treat (ITT) analysis (n=94), there was a larger mean decrease from baseline (improvement) on the Yale-Brown Obsessive Compulsive Scale (YBOCS) score (the primary efficacy outcome) in the active treatment group (-6.0 points) than the sham group (-2.8 points), translating to a moderate effect size of 0.69. At 6 weeks, the response rate was 38.1% in the active treatment group compared to 11.1% in the sham group (p=.003), as measured by a 30% or greater increase in the YBOCS. The difference in the primary outcome measure between active and sham groups was not statistically significant in the ITT analysis. There was a benefit for TMS on clinician reported measures of improvement, but no significant difference between groups on patient-reported disability and impairment. Additional trials with sufficient sample size and follow-up duration are needed to confirm these results.
Hayes Inc. published a health technology assessment in 2019, that was last reviewed in 2022 for transcranial magnetic stimulation for the treatment of obsessive-compulsive disorder in the adult population. Hayes provided two different ratings. Hayes gave a “C” rating for the use of repetitive transcranial magnetic stimulation (rTMS) as an add-on therapy for obsessive-compulsive disorder (OCD) in adult individuals with an inadequate response to > 1 prior treatments without contraindications to rTMS According to Hayes a C rating indicates, “This Rating reflects a low-quality body of evidence that rTMS may improve clinical outcomes in patients with OCD. Considerable uncertainty remains regarding the effectiveness of rTMS versus sham or alternative treatments, the clinical significance of improvement with rTMS treatment, durability of benefit, optimal treatment parameters (i.e., high- versus low-frequency stimulation and choice of cortical target), and patient selection criteria.” 2. Hayes gave a “D2” rating for the second was for the use of rTMS as monotherapy for OCD in adults with inadequate response to >1 prior treatments without contraindications to rTMS which. a D2 rating indicates, “the paucity of evidence related to this indication.”
A systematic review by Trevizol et al. (2016) included 15 RCTs (N=483) that compared active with sham rTMS for OCD. All studies were sham-controlled and double-blind. The sample sizes in the trials ranged from 18 to 65 patients. Seven studies used low-frequency stimulation and 8 studies used high-frequency stimulation. The cortical regions varied among the studies, targeting the supplementary motor area, orbitofrontal cortex, or left, right, or bilateral DLPFC. The researchers calculated the SMD for the primary outcome (YBOCS score). Response rates were not reported. The pooled mean difference between groups on the YBOCS was 2.94 (95% CI, 1.26 to 4.62), translating to a small to moderate effect size for active stimulation of 0.45 (95% CI, 0.20 to 0.71). Individual adverse effects were not assessed due to a lack of reporting in the primary studies, but there was no difference between groups in the dropout rate. Intervention protocols were heterogeneous across the studies, but regression analysis did not identify any treatment protocol or other variables as predictors of TMS response.
More recently, Liang et al (2021) conducted a systematic review and meta-analysis of different TMS modalities for the treatment of OCD. Three of the 5 protocols assessed were significantly more efficacious than sham TMS, and all treatment strategies were similar to sham TMS regarding tolerability. Transcranial magnetic stimulation was not more effective than sham TMS, but there was direct evidence from only 1 RCT for this comparison (Carmi et al, 2019, discussed in the next section). The overall quality of the evidence was rated very low for efficacy and low for tolerability, and the reviewers concluded that high quality RCTs with low selection and performance bias are needed to further verify the efficacy of specific rTMS strategies for OCD treatment.
Perera et al. (2021) conducted a systematic review and meta-analysis of rTMS in the treatment of OCD. All RCTs in the analysis (n=26) had a low risk of bias. A random effects model was used to compare preand post-stimulation YBOCS scores, with effect sizes reported as Hedges' g. The analysis found that rTMS had a significant effect on YBOCS scores compared to sham (effect size, 0.64; 95% CI, 0.39 to 0.89; p <0.001) Raw mean difference in YBOCS score between treatments was 4.04 (95% CI, 2.54 to 5.54; p.001) The effect size was still significant when 2 dominant trials were removed. Effect sizes with rTMS appeared to be significant until 4 weeks after treatment, and low- and high-frequency rTMS had similar efficacy to each other. The authors performed several subgroup analyses (cortical target, stimulation frequency, total pulses per session, total duration of treatment) but none of the effect sizes were significant between rTMS and sham.
RCT of deep TMS for OCD was conducted by Carmi et al. (2019). The trial was submitted to the FDA as part of the de novo classification request, to establish a reasonable assurance of safety and effectiveness of the device. Study characteristics, results, and limitations are summarized in the tables below. A total of 99 patients were randomized to active treatment or sham. The primary outcome was the difference between groups in the mean change from baseline to 6 weeks on the YBOCS. Secondary outcomes included the response rate (defined as a 30% or greater improvement from baseline on the YBOCS), the Clinical Global Impression of Improvement (CGI-I), the Clinical Global Impression of Severity (CGI-S), and the Sheehan Disability Scale, a patient-reported measure of disability and impairment. Results at 10 weeks were also reported as secondary outcomes. The primary efficacy analysis used a modified ITT analysis (n=94), excluding 5 patients who were found to not meet eligibility criteria following randomization. There was a greater decrease from baseline in the active treatment group (-6.0 points) than the sham group (-2.8 points), translating to a moderate effect size of 0.69. At 6 weeks, the response rate was 38.1% in the active treatment group compared to 11.1% in the sham group (p=.003). The FDA review provides data from the ITT analysis of the mean change in the YBOCS score (n=99). In the ITT data set, the YBOCS score decreased by -6.0 points (95% CI, -3.8 to -8.2) in the active group and by -4.1 points (95% CI, -1.9 to -6.2) in the sham group. Although the decreases were both statistically significant from baseline, the difference of 1.9 points between the treatment arms was not statistically significant (p=.0988). Results on the secondary outcomes were mixed. More patients in the active treatment group were considered improved based on the CGI-I and the CGI-S at 6 weeks, but there was no significant difference between groups on the Sheehan Disability Scale.
Within the literature available on OCD, limitations include a lack of standardized protocol and a lack of high-quality studies. Current studies have small sample sizes, bias, poor design, limited follow-up, and inconsistent results. The authors agree there is a low risk associated with treatment, but the literature suggests safety and long-term data has not been obtained. There is a trend towards a benefit, as noted in the meta-analysis and randomized control trials, that suggest there may be a role in refractory OCD. However, many questions remain in terms of the efficacy, location of the device application, and the frequency/duration of the treatment. Several systematic reviews/meta-analyses conclude that TMS demonstrated a range from non-response to modest effect on the reduction of OCD symptoms. Further research is required to determine optimal frequency, total pulses per session, and duration of treatment.
For individuals who have psychiatric, neurological disorders, or other conditions outside of depression or obsessive-compulsive disorder including but not limited to chronic pain, fibromyalgia, generalized anxiety disorder, post-traumatic stress disorder, and schizophrenia who receive TMS the evidence includes numerous small RCTs and meta-analyses of these randomized trials. The trials are typically small and of low methodologic quality. There are no large, high-quality trials for any of these conditions demonstrating efficacy or the durability of any treatment effects.
Bipolar Disorder
Konstantinou et al (2022) conducted a systematic review of 31 RCTs of rTMS for the treatment of bipolar disorder; meta-analysis was not performed. Most included studies were in the setting of bipolar depression (n=24). Only 8 studies had a low risk of bias. Overall, rTMS seems safe and well-tolerated but efficacy results are mixed and there is no consensus about the optimal rTMS regimen. The authors noted limitations of the available literature including heterogeneity among studies, differences in sham treatments, and small sample sizes. They also stated that adequately powered sham-controlled studies are needed to verify the efficacy of rTMS in patients with bipolar disorder.
Tee et al (2020) conducted a systematic review and meta-analysis of sham controlled RCTs of rTMS for the treatment of bipolar disorder. Eight trials of rTMS in bipolar depression showed small but statistically significant improvements in depression scores compared to sham control (SMD, 0.302; p<0.05) However, most studies had a high risk of bias, which could have exaggerated the treatment effects. The effect of rTMS was inconclusive in bipolar mania due to the high heterogeneity and limited number of controlled trials.
Hayes Inc. published a Health Technology Assessment on March 10, 2023 on repetitive transcranial magnetic stimulation for the treatment of bipolar disorder that was again reviewed in March 2024. The assessment provided a Hayes rating of D2 indicating published evidence is insufficient to assess the safety and/or impact on health outcomes or patient management for the use of repetitive transcranial magnetic stimulation (rTMS in adult patients with bipolar depression.
He et al (2017) published a meta-analysis of the effects of 1-Hz (low frequency) and 10-Hz (high frequency) rTMS for auditory hallucinations and negative symptoms of schizophrenia, respectively. For 1- Hz rTMS, 13 studies were included. Compared with sham, the rTMS group showed greater improvement in auditory hallucinations (SMD, -0.29; 95% CI, -0.57 to -0.01). However, significant heterogeneity across the studies was found (p=.06). In the 7 studies using 10-Hz rTMS, the overall effect size for improvement in negative symptoms was -0.41 (95% CI, -1.16 to -0.35); again, there was significant heterogeneity across studies The review was further limited by the small number of articles included and by the lack of original data for some studies. A Cochrane review by Dougall et al (2015) selected 41 studies (N=1473 participants). Based on very lowquality evidence, there was a significant benefit of low- and high-frequency temporoparietal TMS compared with sham for the global state (7 RCTs) and positive symptoms (5 RCTs). For prefrontal rTMS compared with sham, the evidence on global and cognitive state was of very low-quality and equivocal. Reviewers concluded that the evidence was insufficient to support or refute the use of TMS to treat symptoms of schizophrenia and, although some evidence suggested that temporoparietal TMS might improve certain symptoms (e.g., auditory hallucinations, positive symptoms of schizophrenia), the results were not sufficiently robust to provide certainty.
Shi et al (2024) included 10 reviews in their systematic review and meta-analysis on accelerated transcranial magnetic stimulation (aTMS) evaluating the efficacy and maintained long-term effects on individuals with MDD. The results did show reduced depression scores post aTMS “(SMD = 1.80, 95% CI (1.31, 2.30), p < 0.00001)”. Although there was a positive effect on depression scores directly after aTMS, scores at follow-up were lower based on the depression rating scale “(SMD = 0.22, 95% CI (0.06, 0.37), p = 0.006)” which raises questions about the long-term maintenance of aTMS. “At the end of treatment with the accelerated repetitive transcranial magnetic stimulation (arTMS) mode, depressive symptoms may continue to improve (SMD = 0.29, 95% CI (0.10, 0.49), I2 = 22%, p = 0.003), while the accelerated intermittent theta burst stimulation (aiTBS) mode only maintains posttreatment effects (SMD = 0.01, 95% CI (-0.45, 0.47), I2 = 66%, p = 0.98).” No remarkable difference in therapeutic effectiveness between aTMS and standard TMS (SMD = -0.67, 95% CI (-1.62, 0.27), p = 0.16).
In 2019, Best et. al. reported on the first study to examine the long-term clinical benefits of combining transcranial magnetic stimulation (TMS) and ketamine infusions, for patients with treatment-resistant depression. The mean reduction in clinical global impression (CGI) severity for the patient group following combination therapy was 4.46 at a 99% confidence interval and was deemed statistically significant (p < 0.0001). This reduction was sustained for two years following treatment completion and this remission was deemed statistically significant (p< 0.0001). This small study (n=29) demonstrated that depressive symptoms, as determined with the clinical global impression (CGI) severity scale, could be markedly reduced following combination treatment and does have promising results, but more studies are needed to quantify the added value of a ketamine product as an augmentation to TMS for patients with treatment-resistant depression
nTMS
Jeltema et al. (2020) published a systematic review of articles that compared nTMS to intraoperative DCS for mapping of motor or language function. Among 8 articles which evaluated mapping language function, sensitivity ranged from 10% to 100% and specificity ranged from 13.3% to 98% when nTMS was compared to DCS. The positive predictive value (PPV) ranged from 17% to 75% and the negative predictive value ranged from 57% to 100%. Most studies of nTMS are case series or cohort studies evaluating patients with brain tumors, cavernous angiomas, arteriovenous malformations, gliomas, or other brain lesions;
Practice Guidelines and Position Statements
In 2007 the APA released a practice guideline for the Treatment of Patients with Obsessive-Compulsive Disorder indicated that “findings of the four published trials of rTMS are 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. The APA released practice guideline for the Treatment of Patients with Schizophrenia in 2020 that states, “Although studies have also been done with TMS for treatment of hallucinations and for treatment of negative symptoms, at present there is insufficient evidence of benefit to suggest use of TMS in individuals with schizophrenia.”
In 2020, the NICE stated that rTMS has not demonstrated any major safety concerns for management of obsessive-compulsive disorder or auditory hallucinations, but evidence for both uses is lacking; therefore, NICE recommends that rTMS be used in patients with these conditions only in the context of research.
In a clinical practice guideline for the management of MDD (2022), the VA/DoD gave a “weak” recommendation for the use of TMS for “patients who have demonstrated partial or no response to two or more adequate pharmacologic treatment trials”. The work group indicated that the quality of evidence is very low with limitations including: “small study effects, higher than optimal discontinuation, lack of measurement for allocation concealment, and/or other issues”. However, they concluded that the benefits of rTMS outweigh the harms.
Hayes published a report on Theta Burst Stimulation for Treatment-Resistant Unipolar Depression in Adults noting: Major depressive disorder (MDD) is a leading cause of global morbidity. Approximately 30% of people with MDD experience treatment resistance, which is characterized by failure of the condition to respond adequately to evidence-based conservative treatments, including pharmacotherapy and psychotherapy Repetitive transcranial magnetic stimulation (rTMS) has emerged as a safe and effective intervention for adult patients experiencing treatment-resistant depression (TRD) (Cosmo et al., 2021); however, it involves an intensive regimen that can be burdensome on patients. A new form of rTMS, referred to as theta burst stimulation (TBS).
Hayes published a report on Maintenance Repetitive Transcranial Magnetic Stimulation for Prevention of Recurrent Depression in Adults, concluding the following: A body of very low-quality evidence on the key outcomes are insufficient to draw conclusions regarding the efficacy and safety of rTMS for preventing recurrence of depressive symptoms in patients with MDD. Current evidence suggests that rTMS may not be effective for the treatment of MDD. For 3 of 4 studies, use of rTMS resulted in rates of clinical response and remission of depressive symptoms similar to those found with sham treatment or clinical observation and did not statistically significantly improve depressive symptoms. A fourth study found a statistically significantly lower relapse rate among patients receiving rTMS compared with those receiving usual care.
CMS L33398 Transcranial Magnetic Stimulation
There is currently insufficient evidence to show use of dTMS for OCD as reasonable and necessary for the treatment of illness or injury [SSA § 1862 (a)(1)(A)] in the Medicare population. TMS studies have heterogenous populations, vary in frequency and site of stimulation, have mixed results, and short follow-ups. The d-TMS investigations are in their infancy with one randomized double-blind controlled trial studying 99 patients, with a 12% drop-out rate, and a four-week follow-up. (Carmi et al.,2019). With the exception of Roth et al, 2021, the patients in the literature submitted for LCD reconsideration were participants in the Carmi et al, 2019 trial. There was insufficient information to support coverage of d-TMS to treat OCD. The ability of d-TMS to improve outcomes in patients with OCD is yet to be determined.
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