This policy has been updated periodically with searches of the MEDLINE database. The most recent literature update was performed through April 9, 2026.
TREATMENT-RESISTANT DEPRESSION
Studies published prior to 2008 are included if the study design was a randomized sham-controlled double-blind trial that enrolled at least 40 subjects; refer to the 2008 meta-analysis by Schutter for a summary of study characteristics and stimulation parameters used in these trials. Note that over the last decade, there has been a trend to increase the intensity, trains of pulses, total pulses per session, and number of sessions (Gross, 2007).
Systematic Reviews
In pediatric major depressive disorder, Gallop et al (2025) identified 28 studies (n=640 participants), including 4 double-blind, sham-controlled RCTs, 1 additional trial which compared low-frequency vs. high-frequency rTMS, 6 open-label cohort studies, and multiple case reports. The largest RCT (n=103) found no significant difference between active and sham rTMS on clinician-rated depression severity or remission rates, while another RCT (n=100) showed that rTMS combined with a selective serotonin reuptake inhibitor (SSRI) produced significantly greater reductions in HAM-D, children's depression rating scale-revised (CDRS-R) scores, and higher response rates than SSRI alone.
In 2016, the Health Quality Ontario published a meta-analysis of left DLPFC rTMS for TRD. Reviewers included 23 RCTs (n=1156 patients) that compared rTMS with sham and 6 RCTs (n=266 patients) that compared rTMS with ECT. In 16 studies, patients received rTMS in addition to antidepressant medication.
Brunoni et al (2017) conducted a systematic review to compare different modalities of rTMS for TRD.
A systematic review conducted by Voigt et al (2021) focused on theta burst stimulation of TRD. The reviewers included 8 RCTs comparing theta burst stimulation to sham treatment and 1 comparing theta burst stimulation to conventional rTMS.
The ASCERTAIN-TRD study was a 3-arm, open-label study published by Papakostas et al (2024). In this study, patients with TRD (failed > 2 antidepressants) were randomized to augmentation with either aripiprazole or rTMS or were switched to venlafaxine XR. The study was open-label and limited to 8 weeks duration. A total of 235 individuals completed the study.
Theta Burst Stimulation Compared to Conventional Transcranial Magnetic StimulationBlumberger et al (2018) published a multicenter, randomized noninferiority trial (THREE-D) comparing 10-Hz rTMS with intermittent theta burst stimulation (iTBS). Between 2013 and 2016, 414 patients with treatment-resistant major depressive disorder were enrolled and randomized to 4 to 6 weeks of rTMS (n=205) or iTBS (n=209).
Deep Transcranial Magnetic Stimulation
The RCT leading to 510(k) clearance of the Brainsway deep TMS system was conducted at 20 centers in the U.S. (n=13), Israel (n=4), Germany (n=2), and Canada (n=1) (FDA, 2013). The study included 229 patients with major depressive disorder who had not received benefit from 1 to 4 antidepressant trials or were intolerant to at least 2 antidepressant treatments.
Accelerated Transcranial Magnetic Stimulation
Cole et al (2022) published a double-blind, randomized, sham-controlled trial of Stanford neuromodulation therapy (SNT), an accelerated, high-dose, fMRI-guided iTBS protocol, in adults with TRD. A total of 32 participants were randomized at the planned interim analysis; 29 who continued to meet inclusion criteria received active (n=14) or sham (n=15) SNT. The study was limited by its small sample size after early stopping at an interim analysis, its single-center design, and the absence of a direct comparison with standard rTMS or another active protocol.
Hanlon et al (2026) published a multicenter, blinded, randomized non-inferiority trial comparing accelerated iTBS with standard high-frequency Deep TMS using the H1-coil, supporting FDA 510(k) clearance of the BrainsWay SWIFT protocol. The accelerated protocol used standard coil positioning and did not require image-guided targeting. Limitations include the lack of a sham comparator, the use of a per-protocol primary analysis that excluded 15% of the randomized subjects, and the absence of long-term durability data.
Ramos et al (2025) published a triple-blinded, sham-controlled RCT evaluating accelerated TBS stimulation for TRD. A total of 100 participants with TRD were randomized to active accelerated TBS using scalp-based targeting (n=50) or sham (n=50). The primary outcome was change in 17-item HDRS score at week 5. The study was limited by its single-center design, modest sample size, short follow-up duration, and the absence of a direct comparison with standard rTMS or another active protocol.
Kratter et al (2026) published a double-blind, randomized, sham-controlled RCT of SNT-accelerated, high-dose, fMRI-guided iTBS protocol, in adults with TRD. A total of 53 participants with TRD were enrolled; 48 who continued to meet entry criteria were randomized to active (n=24) or sham (n=24) SNT. The study was limited by its modest sample size, single-center design, limited demographic diversity, uncertain long-term durability, and the absence of comparison with conventional rTMS or another active comparator.
Durability of rTMS and Maintenance Therapy
Systematic Reviews
A 2015 meta-analysis by Kedzior et al examined the durability of the antidepressant effect of high-frequency rTMS of the left DLPFC in the absence of maintenance treatment.12 Included were 16 double-blind, sham-controlled RCTs with a total of 495 patients.
Noda et al (2025) published the MAINT-R trial, a randomized clinical trial comparing low-frequency rTMS with lithium pharmacotherapy for relapse prevention in treatment-resistant depression in Japan in individuals who had received prior acute rTMS. A total of 75 participants with TRD who had responded to an acute course of bilateral rTMS in the BEAT-D study were randomized 1:1 to receive weekly low-frequency (1 Hz) rTMS to the right DLPFC (24 sessions of 900 pulses at 120% motor threshold) or 24 weeks of lithium maintenance therapy (target blood level 0.4-0.6 mEq/L). Limitations included the single-blind design, the absence of a placebo control group, conduct at only 2 sites in Japan, a sample size that limits generalizability, and the post hoc nature of the sample size estimation given the study's origin as an extension of the BEAT-D acute-phase trial.
In 2014, Dunner et al reported 1-year follow-up with maintenance therapy from a large multicenter observational study (42 sites) of rTMS for patients with TRD. A total of 257 patients agreed to participate in the follow-up study of 307 who were initially treated with rTMS.
A variety of maintenance schedules are being studied (Richieri et al, 2013; Connolly et al, 2012; Janicak, 2010).
MIGRAINE HEADACHE
Saltychev et al conducted a systematic review and meta-analysis of 8 RCTs that compared rTMS to sham stimulation inpatients with migraine (Saltychev, 2022). All RCTs used high frequency rTMS to the left dorsolateral prefrontal cortex and all studies except 1 included patients with chronic migraine. All studies except 1 had a low risk of bias and the risk of publication bias was nonsignificant. Results for the frequency of migraine days per month and the intensity of migraine pain both favored rTMS; however, the authors stated that the difference in migraine pain intensity was clinically insignificant.
A pivotal randomized, double-blind, multicenter, sham-controlled trial was performed with the Cerena™ TMS device to demonstrate safety and effectiveness for the de novo application (FDA, 2013). According to the FDA labeling, the device has not been demonstrated as safe or effective when treating cluster headache, chronic migraine headache, or when treating migraine headache during the aura phase. The device has not been demonstrated as effective in relieving the associated symptoms of migraine (photophobia, phonophobia, nausea) (FDA,2013).
OBSESSIVE COMPULSIVE DISORDER
Perera et al conducted a systematic review and meta-analysis of rTMS in the treatment of OCD (Perera, 2021). All RCTs in the analysis(n=26) had a low risk of bias. A random effects model was used to compare pre- and 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<.0001). 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 4weeks 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.
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 pre- and 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<.0001). 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.
Joseph et al (2025) conducted a systematic review and meta-analysis of 7 RCTs evaluating accelerated TMS (aTMS) protocols for OCD, defined as 2 or more sessions per day delivered over 1 to 3 weeks.Six studies (N=150; 77 active, 73 sham) were included in the quantitative analysis. aTMS significantly reduced OCD symptoms compared with sham (SMD, 0.63; 95% CI, 0.14 to 1.11; p=.01), with moderate heterogeneity across studies (I²=51%; p=.07). The review was limited by small sample sizes across included trials, heterogeneity in patient populations regarding treatment resistance, varied stimulation protocols and cortical targets, and the small number of available RCTs.
Tseng et al (2025) published a network meta-analysis evaluating the efficacy and acceptability of non-invasive brain stimulation interventions for OCD. The analysis included 34 RCTs comprising 1,089 participants and 24 distinct stimulation methods, with searches conducted through January 27, 2023. The primary outcome was the change in overall OCD severity. The study was limited by heterogeneity across included participants and treatment contexts, including comorbidities, concomitant psychotropic medications, baseline OCD severity, timing of intervention, follow-up duration, and differing response definitions; incomplete assurance of blinding because of device limitations; and relatively short mean treatment and overall study durations, which may have underestimated delayed treatment effects.
A more recent RCT (Carmi et al, 2019). The trial was submitted to FDA as part of the de novo classification request, to establish a reasonable assurance of safety and effectiveness of the device (U.S. Food and Drug Administration, 2018). 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.
PSYCHIATRIC DISORDERS OTHER THAN DEPRESSION OR OBSESSIVE-COMPULSIVE DISORDER
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. The effect of rTMS was inconclusive in bipolar mania due to the high heterogeneity and limited number of controlled trials.
Konstantinou et al conducted a systematic review of 31 RCTs of rTMS for the treatment of bipolar disorder; meta-analysis was not performed (Konstantinou, 2022). 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.
Generalized Anxiety Disorder
Cui et al (2019) included 21 studies (N=1481 patients) in a meta-analysis of rTMS plus drug therapy compared to drug therapy alone for the treatment of generalized anxiety disorder. Results of the analysis showed that rTMS improved anxiety symptoms as measured by the Hamilton Anxiety Scale, (standardized mean difference = -0.68, 95% CI -0.89 to -0.46). The conclusions that could be drawn from the body of evidence were limited by significant heterogeneity across studies, and the authors concluded that additional high-quality studies are needed to confirm the results.
Panic Disorder
A 2014 Cochrane review by Li et al identified 2 RCTs with a total of 40 patients that compared low frequency rTMS with sham rTMS over the right DLPFC. The larger of the 2 studies was a randomized double-blind sham-controlled trial of low-frequency rTMS to the right dorsolateral prefrontal cortex in 21 patients with panic disorder with comorbid major depression (Mantovani et al, 2013). Response was defined as a 40% or greater decrease on the panic disorder severity scale (PDSS) and a 50% or greater decrease on the HAM-D. After 4 weeks of treatment, the response rate for panic was 50% with active rTMS and 8% with sham. The study had a high risk of attrition bias. The overall quality of evidence for the 2 studies was considered to be low, and the sample sizes were small, precluding any conclusions about the efficacy of rTMS for panic disorder.
Posttraumatic Stress Disorder
In 2016, Trevizol et al published a meta-analysis on the efficacy of rTMS for posttraumatic stress disorder
(PTSD). Five sham-controlled RCTs (total N=118 patients) were included in the review. Most studies used stimulation of the right DLPFC, though some delivered rTMS to the left DLPFC or bilaterally.
Brown et al (2024) published a Cochrane systematic review of rTMS for posttraumatic stress disorder. The search was conducted through January 2023, and the authors identified 13 RCTs (N=577). Notably, 5 studies were conducted in the US, primarily enrolling white, male veterans. The authors found that rTMS probably makes little to no difference on posttraumatic stress disorder severity immediately following treatment (SMD, -0.14; 95% CI, -0.54 to 0.27; 3 studies, 99 participants; moderate-certainty evidence); however, there was significant heterogeneity amongst the studies.
Schizophrenia
Zhu et al conducted a study in China at 7 sites between 2017-2018 (Zhu, 2021). Participants included Inpatients between the ages of 18 to50 years with a diagnosis of schizophrenia per ICD-10 criteria who were right-handed and clinically stable for the past 3 months (N=32). The effect of treatment on positive symptoms and PANSS total scores was not significant.
One of the largest areas of TMS research outside of depressive disorders is the treatment of auditory hallucinations in schizophrenia resistant to pharmacotherapy. In 2011, TEC published an Assessment of TMS as an adjunct treatment for schizophrenia (BCBSA, 2011). Five meta-analyses were reviewed, along with randomized controlled trials (RCTs) in which measurements were carried out beyond the treatment period. A meta-analysis of the effect of TMS on positive symptoms of schizophrenia (hallucinations, delusions, and disorganized speech and behavior) did not find a significant effect of TMS. Four meta-analyses that looked specifically at auditory hallucinations showed a significant effect of TMS. It was noted that outcomes were evaluated at the end of treatment, and the durability of the effect is unknown. The Assessment concluded that the available evidence is insufficient to demonstrate that TMS is effective in the treatment of schizophrenia.
A 2012 meta-analysis included 17 randomized double-blind sham-controlled trials (n=337) of the effect of rTMS on auditory hallucinations (Slotema, 2012). A 2013 meta-analysis by Zhang et al included 17 RCTs (N=398) that evaluated low-frequency rTMS of the left temporoparietal cortex for the treatment of auditory hallucinations. A small (n=18) double-blind randomized sham-controlled trial from 2012 found no significant effect of deep rTMS with an H1 coil on auditory hallucinations (Rosenberg, 2012).
A 2015 Cochrane review by Dougall et al included 41 studies with a total of 1473 participants. Based on very low-quality evidence, there was a significant benefit of temporoparietal TMS compared with sham for global state (7 RCTs) and positive symptoms (5 RCTs). The evidence on the cognitive state was equivocal. For prefrontal rTMS compared with sham, the evidence on global state and cognitive state was of very low quality and equivocal. The review concluded that there is insufficient evidence to support or refute the use of TMS to treat symptoms of schizophrenia and, although some evidence suggests that temporoparietal TMS may improve certain symptoms (eg, auditory hallucinations, positive symptoms of schizophrenia), the results were not robust enough to be unequivocal.
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. Significant heterogeneity across the studies was found (p=0.06). 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 (p<0.001). The review was further limited by the small number of articles included and by the lack of original data for some studies.
SUBSTANCE ABUSE AND CRAVING
Chang et al conducted a meta-analysis of 7 double-blind RCTs (N=462) that used rTMS to treat methamphetamine use disorder (Chang, 2022).
Jansen et al reported a 2013 meta-analysis of the effect of rTMS and transcranial direct current stimulation (tDCS) of the DLPFC on substance dependence (alcohol, nicotine, cocaine, marijuana) or craving for high palatable food. Seventeen double-blind, sham-controlled RCTs that used high frequency stimulation were included in the analysis.
AMYOTROPHIC LATERAL SCLEROSIS OR MOTOR NEURON DISEASE
A Cochrane review by Fang (2013) identified 3 RCTs with a total of 50 participants with amyotrophic lateral sclerosis (ALS) that compared rTMS with sham TMS. All of the trials were considered to be of poor methodologic quality. Heterogeneity prevented pooling of results, and the high rate of attrition further increased the risk of bias. The review concluded that evidence is currently insufficient to draw conclusions about the efficacy and safety of rTMS in the treatment of ALS.
CHRONIC PAIN
Jiang et al conducted a systematic review and meta-analysis of 38 RCTs that assessed the analgesic effect of rTMS in 1338patients with neuropathic pain (Jiang, 2022). A single rTMS session was used in 13 studies and multiple sessions were used in the remaining 25 studies. The authors concluded that larger, well-designed trials are needed to determine the long-term effect of rTMS in this setting.
Su et al conducted a meta-analysis of 18 RCTs (N=643) with rTMS in patients with fibromyalgia (Su, 2021). Questionnaire scores. The authors concluded that larger RCTs are needed to confirm these findings.
A Cochrane review by O’Connell et al evaluating noninvasive brain stimulation techniques was first published in 2010 and was updated in 2014 and 2018. (O’Connell et al, 2014; O’Connell et al, 2018).
EPILEPSY
A 2016 Cochrane review by Chen et al included seven RCTs on rTMS for epilepsy, five of which were completed studies with published data. The total number of participants was 230. All studies had active or placebo controls, and four were double-blinded. However, a meta-analysis could not be conducted due to differences in the design, interventions, and outcomes of the studies. Therefore, a qualitative synthesis was performed. For the outcome of seizure rate, two studies showed a significant reduction and five studies did not. Of the four studies evaluating the mean number of epileptic discharges, three showed a statistically significant reduction in discharges. Adverse effects were uncommon and mild, involving headache, dizziness, and tinnitus. There were no significant changes in medication use.
In 2012, Sun et al reported a randomized double-blind controlled trial of low-frequency rTMS to the epileptogenic zone for refractory partial epilepsy. Sixty patients were randomized into 2 groups; one group received 2 weeks of rTMS at 90% of resting motor threshold and the other group received rTMS at 20% of resting motor threshold. The initial results are promising, but require substantiation in additional trials.
A more recent meta-analysis conducted by Mishra and colleagues (2020) included 7 RCTs that compared rTMS with sham or placebo controls in patients with epilepsy.
FIBROMYALGIA
In 2017, Saltychev and Laimi published a meta-analysis of rTMS for the treatment of patients with fibromyalgia. The meta-analysis included seven sham-controlled double-blinded RCTs with low risk of bias. The sample size of the trials ranged from 18 to 54.
A 2012 systematic review included 4 studies on transcranial direct current stimulation and 5 on rTMS for treatment of fibromyalgia pain. Three of the 5 trials were considered to be high quality.
Additional study is needed to determine effective treatment parameters in a larger number of subjects and to evaluate durability of the effect.
PARKINSON DISEASE
Li et al conducted a meta-analysis of 32 sham controlled RCTs of rTMS in patients with Parkinson disease and motor dysfunction (N=1048 patients) (Li, 2022).
A systematic review from 2009 included 10 randomized controlled trials with a total of 275 patients with Parkinson disease (Elahi, 2009).
In 2012, Benninger et al reported a randomized double-blind sham-controlled trial of brief (6 sec) very-high-frequency (50 Hz) rTMS over the motor cortex in 26 patients with mild to moderate Parkinson disease.
Additional study with a larger number of subjects and longer follow-up is needed to determine if rTMS improves motor symptoms in patients with Parkinson disease.
STROKE
Qiao et al performed a meta-analysis of RCTs that assessed the effect of rTMS in 433 patients with post-stroke dysphagia (Qiao, 2022).
A 2013 Cochrane review included 19 RCTs with a total of 588 participants on the effect of TMS for improving function after stroke (Hao et al, 2013).
Hsu et al (2012) reported a meta-analysis of the effect of rTMS on upper limb motor function in patients with stroke.
Hand Function
A 2014 meta-analysis assessed the effect of rTMS on the recovery of hand function and excitability of the motor cortex after stroke.33 Eight RCTs (total N=273 participants) were included in the review.
Aphasia
A 2015 meta-analysis included 4 RCTs on rTMS over the right pars triangularis for patients (total N=137 patients) with aphasia after stroke (Li et al, 2015).
Upper-Limb
Zhang et al (2017) published a systematic review and meta-analysis evaluating the effects of rTMS on upper-limb motor function after stroke.
In 2016, Graef et al reported a meta-analysis of rTMS combined with upper-limb training for improving function after stroke. Included were 11 sham-controlled randomized trials with 199 patients that evaluated upper-limb motor/functional status and spasticity; 8 RCTs with sufficient data were included in the meta-analysis. These studies were considered to have a low-to-moderate risk of bias. In the overall analysis, there was no benefit of rTMS on upper-limb function or spasticity.
SUMMARY OF EVIDENCE
For individuals who have treatment-resistant depression (TRD) who receive transcranial magnetic stimulation (TMS), the evidence includes a large number of sham-controlled randomized controlled trials (RCTs) and meta-analyses of these trials. Relevant outcomes are symptoms, functional outcomes, and quality of life. Meta-analyses found improved response rates and rates of remission for conventional TMS and theta burst stimulation compared with sham TMS. Additionally, a head-to-head trial showed noninferiority of theta burst stimulation to conventional TMS, with no difference in the incidence of adverse events. Meta-analyses have concluded that the effect of TMS on average depression scores is smaller than the effect of electroconvulsive therapy (ECT) on TRD and that the mean improvement in depression scores with TMS did not reach the minimal clinically important difference; however, clinically meaningful improvements were noted in a subgroup of studies using higher frequency pulses. One potential area of benefit for TMS is in accelerating or enhancing the response to antidepressant medications, and there is some evidence that TMS, when given in conjunction with the initiation of pharmacologic therapy, improves the response rate compared with pharmacologic therapy alone. The effect of TMS appears to be less robust when it is given in combination with a stable dose of antidepressant medication. Meta-analyses have also found that the efficacy of TMS decreases with longer follow-up, though some studies have reported a persistent response up to 6 months in some patients. There is limited evidence to compare the effects of these treatments on cognition, although the adverse events of TMS appear to be minimal. While meta-analyses have reported that the effect of TMS is smaller than the effect of ECT on TRD, because TMS does not require general anesthesia or induce seizures, some individuals may decline ECT so the balance of incremental benefits and harms associated with TMS may be reasonable compared with ECT. Four RCTs have evaluated accelerated TMS protocols for TRD: 2 sham-controlled trials of fMRI-guided SNT demonstrated high response and remission rates, while 1 sham-controlled trial without neuroimaging also showed significant benefits; a fourth trial demonstrated noninferiority of accelerated iTBS to standard deep TMS also without requiring neuroimaging. It remains uncertain whether fMRI-guided targeting confers incremental benefit over standard coil placement, and long-term durability data beyond are limited across all accelerated protocols. Based on the short-term benefit observed in RCTs and the lack of alternative treatments aside from ECT in patients with TRD, TMS may be considered a treatment option in patients with TRD who meet specific criteria. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.
For individuals who have migraine headaches who receive TMS, the evidence includes a systematic review (n=8 trials) and a sham-controlled RCT of 201 patients conducted for submission to the Food and Drug Administration (FDA) for clearance in 2013. Relevant outcomes are symptoms, functional outcomes, and quality of life. The systematic review found that repetitive TMS (rTMS) reduced migraine pain intensity and frequency compared to sham; it was unclear whether patients were receiving background pharmacotherapy. The trial results were limited by the 46% dropout rate and the use of a post hoc analysis. No recent studies have been identified with these devices. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
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. Multiple meta-analyses (ranging from 26 to 34 RCTs) have found a significant effect of rTMS on YBOCS scores compared to sham, with effect sizes in the small-to-moderate range, though the effect appears to persist only until approximately 4 weeks after treatment. Network meta-analyses have identified several stimulation approaches that may be effective, but deep TMS was not found to be more effective than sham based on limited direct evidence. A meta-analysis of 6 RCTs (N=150) found that accelerated TMS protocols (=2 sessions/day over 1-3 weeks) significantly reduced OCD symptoms compared with sham (SMD, 0.63; p=.01) with higher response rates (OR, 4.28), though improvements were not sustained at 2-8 week follow-up assessments 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. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
For individuals who have psychiatric or neurological disorders other than depression, migraine, or OCD (eg, bipolar disorder, generalized anxiety disorder, panic disorder, posttraumatic stress disorder, schizophrenia, substance use disorder and craving, amyotrophic lateral sclerosis, chronic pain, epilepsy, fibromyalgia, Parkinson disease, stroke recovery) who receive TMS, the evidence includes numerous small RCTs and meta-analyses of these randomized trials. Relevant outcomes are symptoms, functional outcomes, and quality of life. The trials included in the meta-analyses are typically small and of low methodologic quality. In addition, stimulation parameters have not been established, and trial results are heterogeneous. There are no large, high-quality trials for any of these conditions demonstrating efficacy or the durability of any treatment effects. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
Ongoing and Unpublished Clinical Trials
A search of online site ClinicalTrials.gov registry identified several currently unpublished trials that might influence this policy.
PRACTICE GUIDELINES AND POSITION STATEMENTS
American Academy of Child and Adolescent Psychiatry
In 2013, the American Academy of Child and Adolescent Psychiatry published practice parameters on the assessment and treatment of children and adolescents with tic disorders (Murphy et al, 2013). The Academy did not recommend rTMS, citing the limited evidence on the safety, ethics, and long-term impact on development.
American Psychiatric Association
In 2018, the American Psychiatric Association published consensus recommendations on rTMS for the treatment of depression (McClintock et al, 2017). The guidelines state, "Multiple randomized controlled trials and published literature have supported the safety and efficacy of rTMS antidepressant therapy." The recommendations include information on the following variables: clinical environment, operator requirements, documentation, coils, cortical targets, coil positioning methods, determination of motor threshold, number of treatment sessions for acute treatment, and allowable psychotropic medications during TMS treatment.
The Association’s guidelines on the treatment of patients with obsessive-compulsive disorder (2007, reaffirmed in 2012) have indicated that “findings of the four published trials of repetitive TMS (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.”
International Headache Society
In 2025, the International Headache Society (Yuan et al on behalf of IHS) published evidence-based guidelines on the use of non-invasive neuromodulation devices for the acute and preventive treatment of migraine (The guideline was developed by a working group using GRADE methodology and a systematic review of 6 databases from 1946 through April 2025; 15 studies met inclusion criteria for the evidence-based recommendations. Evidence quality ranged from very low to moderate. For acute migraine treatment, the panel issued weak (conditional) recommendations in favor of SAVI Dual, Cefaly, Relivion, and Nerivio. For preventive migraine treatment, weak recommendations in favor of gammaCore Sapphire, Cefaly, and Nerivio were issued. Other cleared devices received no recommendation or had no eligible studies for GRADE assessment. The primary limitations across studies were imprecision due to small sample sizes and methodological concerns. The panel concluded that non-invasive neuromodulation devices offer promising alternatives to drug treatment for migraine, are generally safe and well tolerated, and are devoid of drug interactions, but that additional higher-quality studies are needed to better define their role in clinical practice.
International Neuromodulation Society/North American Neuromodulation Society
In 2020, an expert consensus panel from the International Neuromodulation Society-North American Neuromodulation Society performed a literature review and published recommendations for transcranial magnetic stimulation in the treatment of pain and headache (Leung, 2020). For neuropathic pain, the panel recommended transcranial magnetic stimulation to the primary motor cortex (high level evidence) or the left dorsolateral prefrontal cortex (F3 location) (at least moderate level evidence). For postoperative pain, the panel recommended that transcranial magnetic stimulation to the F3 location be only selectively offered due to at least moderate certainty that the net benefit is small. For primary headache, the panel only based 2 recommendations on moderate certainty evidence: single transcranial magnetic stimulation for acute migraine and high frequency rTMS to the primary motor cortex for migraine prevention. For posttraumatic brain injury, high level evidence supported a recommendation for high-frequency transcranial magnetic stimulation to the primary motor cortex or the F3 location.
National Network of Depression Centers/Clinical TMS Society/International Federation of Clinical Neurophysiology
In 2025, the National Network of Depression Centers (NNDC) Neuromodulation Task Group published an updated consensus review on TMS for the treatment of depression, endorsed by the Clinical TMS Society and the International Federation of Clinical Neurophysiology (Trapp et al, 2025). The panel equally recommended iTBS and standard high-frequency rTMS as "appropriate initial antidepressant treatment protocols," based on non-inferiority data. The Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT) protocol was noted as FDA-cleared and promising, but the consensus stated that "additional studies are needed" for independent replication and long-term durability assessment. Regarding maintenance TMS, the consensus characterized the evidence as "promising, although the frequency of maintenance treatments needed to sustain benefit is unclear," and called for "larger scale randomized controlled trials." For bipolar depression, the panel found a smaller magnitude of effect with concern for treatment-emergent mania. For other mood disorders, including PTSD, depression secondary to traumatic brain injury, and depression in the context of substance use disorders, the evidence was described as "mixed and limited, with no definitive conclusions or consensus recommendations at this juncture." The consensus also updated the contraindication threshold for ferromagnetic material near the TMS coil from 30 cm to 10 cm based on updated safety data. The panel recommended that patients receive the full treatment course of 30 to 36 sessions and that rTMS be considered earlier in antidepressant treatment algorithms, given evidence that rTMS augmentation may be superior to switching pharmacologic agents in treatment-resistant depression.
National Institute for Health and Care Excellence
In 2015, the National Institute for Health and Care Excellence provided revised guidance, stating that evidence on the short-term efficacy of rTMS for depression is adequate, although the clinical response is variable and some patients may not benefit (NICE, 2015).
In 2014, the Institute provided guidance on the use of rTMS for treating and preventing migraine (NICE, 2014). The guidance stated that evidence on the efficacy of TMS for the treatment of a migraine was limited in quantity and for the prevention of a migraine was limited in both quality and quantity. Evidence on its safety in the short and medium term was adequate, but there was uncertainty about the safety of long-term or frequent use of TMS.
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.
Veteran's Affairs/Department of Defense
The 2022 Veteran's Affairs/Department of Defense guideline for management of major depressive disorder recommends offering rTMS to patients who have experienced partial response or no response to an adequate trial of 2 or more pharmacologic treatments (strength of recommendation: weak) (VA/DoD Clinical Practice Guideline, 2022). Recommended options for the second treatment attempt after the initial therapy tried include switching to another antidepressant or adding augmentation therapy with a second-generation antipsychotic. The recommendation for rTMS was graded as weak due to limitations of the available literature including small study effects, high rates of discontinuation, lack of allocation concealment, and the practical limitations of the need for daily treatment and lack of widespread access
to facilities that offer this therapy. The guideline also concluded that there is limited evidence to recommend for or against theta-burst stimulation for treatment of depression.
The 2023 VA/DoD guideline for management of bipolar disorder states "for individuals with bipolar disorder who have demonstrated partial or no response to pharmacologic treatment for depressive symptoms, we suggest offering repetitive transcranial magnetic stimulation [rTMS] as an adjunctive treatment." However, the recommendation was rated as "weak" and the confidence in the evidence was very low. For the management of PTSD, the 2023 guideline found insufficient evidence for or against rTMS.
U.S. Preventive Services Task Force Recommendations
Not applicable.
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