Repetitive Transcranial Magnetic Stimulation (rTMS) in Adults with Treatment Resistant Major Depressive Disorder

Title XVIII of the Social Security Act (SSA) §1862(a)(1)(A). This section allows coverage and payment for only those services that are considered to be medically reasonable and necessary.

Title XVIII of the Social Security Act (SSA) §1833(e). This section prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physician examinations.

Title XVIII of the Social Security Act (SSA) §1862(a)(1)(D), and (E). Investigational or Experimental.

Transcranial Magnetic Stimulation (TMS) is a non-invasive treatment that uses pulsed magnetic fields to induce an electric current in a localized region of the cerebral cortex. An electromagnetic coil placed on the scalp induces focal current in the brain that temporarily modulates cerebral cortical function. Capacitor discharge provides electrical current in alternating on/off pulses. Stimulation parameters may be adjusted to alter the excitability of the targeted structures in specific cortical regions. Repetitive TMS (rTMS) has been investigated as treatment for pharmacoresistant depression.

TMS parameters include cranial location, stimulation frequency, duration, and intensity. TMS is delivered in outpatient settings without anesthesia or analgesia. Typically for the treatment of depression, the coil is located over the left prefrontal cortex. The rTMS is performed daily (weekdays) for 6 weeks. There is no need for anesthesia or analgesia and there are no restrictions about activities before or after treatment (e.g. driving, working, operating heavy machinery).

When used as an antidepressant therapy, TMS produces a clinical benefit without the systemic side effects attendant with standard oral medications. TMS does not have adverse effects on cognition. Unlike electroconvulsive therapy (ECT), rTMS does not induce amnesia or seizures.

Indications for Coverage

Noridian considers TMS therapy reasonable and necessary when it is furnished in accordance with the accepted standards of medical practice, when it is furnished in a setting appropriate to the patient’s medical needs and condition, when it meets but does not exceed the patient’s medical need and when it is ordered and furnished by qualified personnel. It is expected that TMS therapy will be ordered by a psychiatrist and furnished under the direct supervision of a qualified physician (MD or DO) who has experience administering TMS therapy.

Initial Treatment

Left Prefrontal rTMS of the brain is considered medically necessary for use in an adult who meets all four of the following criteria:

1. Has a confirmed diagnosis of severe major depressive disorder (MDD) single or recurrent episode; and

2. One or more of the following:

• Resistance to treatment with psychopharmacologic agents as evidenced by a lack of a clinically significant response to a single trial of psychopharmacologic agents in the current depressive episode; or
  
  
• Inability to tolerate psychopharmacologic agents as evidenced by two trials of psychopharmacologic agents from two different agent classes; or
  
  
• History of response to rTMS in a previous depressive episode; or
  
  
• A history of response to ECT in a previous or current episode or an inability to tolerate ECT, or is a candidate for, but has declined ECT and rTMS is considered a less invasive treatment option.

Resistance to treatment is defined by a failure to achieve a 50% reduction in depressive symptoms, in accordance with objective measures such as Geriatric Depression Scale (GDS), the Personal Health Questionnaire Depression Scale (PHQ-9), the Beck Depression Inventory (BDI), the Montgomery Asberg Depression Rating Scale (MADRS), the Quick Inventory of Depressive Symptomatology (QIDS), the Inventory for Depressive Symptomatology Systems Review (IDS-SR) or Hamilton Rating Scale for Depression (HAM-D), from a pharmacologic trial where the medication is administered at both an adequate dose and for an adequate period of time consistent with accepted standards of care.

A dose will be considered adequate when the medication is administered consistent with the FDA label. Where starting dosage is lower than maximum recommended dosage, the dose of any medication will be considered adequate when an initial response failure is followed by titrating the dosage upwards towards the maximum recommended dosage. Where such titration does not occur, the record must document the rationale for the decision not to increase the dose.

Duration of therapy will be considered adequate, when a particular medication is administered for a length of time consistent with expectations for expected response times for that medication or class of medications as defined in the medical literature supporting the efficacy of that medication or medication class and by the standard of care. Psychopharmacologic agent side effects will be considered intolerable, when those side effects are of a nature where they are not expected to diminish or resolve with continued administration of the drug.

AND

3. A trial of an evidence-based psychotherapy known to be effective in the treatment of MDD of an adequate frequency and duration without significant improvement in depressive symptoms as documented by standardized rating scales that reliably measure depressive symptoms.

AND

4. The order for treatment (or retreatment) is written by a psychiatrist (MD or DO) who has examined the patient and reviewed the record. The psychiatrist will have experience in administering TMS therapy. The treatment shall be given under direct supervision of a qualified physician (physician present in the area and immediately available but does not necessarily personally provide the treatment).

NOTE: Please refer to the "Provider Qualification" section for qualified physician and direct supervision requirements.

Therapeutic repetitive transcranial magnetic stimulation treatment; subsequent motor threshold re-determination with delivery and management is considered reasonable and necessary when there is a change in clinical status or medical regimen that is expected to alter cortical excitability.  The medical record must clearly document the rationale for the performance of a motor threshold redetermination.  

Retreatment

Retreatment may be considered for patients who met the guidelines for initial treatment and subsequently developed relapse of depressive symptoms as evidenced by a 50% worsening in the prior best response using the same rating scale (e.g., GDS, PHQ-9, BDI, HAM-D, MADRS, QIDS or IDS-SR scores).

Patients must have responded to prior treatments as evidenced by a greater than 50% improvement in standard rating scale measurements for depressive symptoms. (e.g., GDS, PHQ-9, BDI, HAM-D, MADRS, QIDS or IDS-SR scores).

Coverage Limitations

TMS therapy not ordered by a psychiatrist who has experience administering TMS therapy and furnished under direct supervision, by a qualified physician (MD or DO), will be considered not medically reasonable and necessary and not subject to coverage.

The treatment must be provided by use of a device approved by the FDA for the purpose of supplying Transcranial Magnetic Stimulation.

The benefits of TMS use must be carefully considered against the risk of potential side effects in patients. The use of TMS in patients with any of the following may be considered not medically reasonable and necessary will not be covered:

• Seizure disorder or any history of seizures (except those induced by ECT or isolated febrile seizures in infancy without subsequent treatment or recurrence) or any condition or treatment that may lower the seizure threshold; or
  
  
• Presence of acute or chronic psychotic symptoms or disorders (such as schizophrenia, schizophreniform or schizoaffective disorder) in the current depressive episode; or
  
  
• Neurological conditions that include epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, history of repetitive or severe head trauma, or primary or secondary tumors in the central nervous system, or
  
  
• Presence of an implanted magnetic-sensitive medical device located less than or equal to 30 cm from the TMS magnetic coil or other implanted metal items including, but not limited to a cochlear implant, implanted cardiac defibrillator (ICD), pacemaker, Vagus nerve stimulator (VNS), or metal aneurysm clips or coils, staples or stents.
  
  
• All other uses of Transcranial Magnetic Stimulation, including "maintenance therapy", “continuous therapy”, “rescue therapy” and “extended active therapy” are considered investigational and experimental as they are not supported by controlled clinical trials and they are considered not reasonable and necessary. This non-coverage is extended to any other terminology that may be given to a treatment episode that does not meet the defined requirements noted and defined as initial treatment or retreatment.  

Retreatment that occurs in close temporal proximity to a previous episode of treatment may be considered maintenance therapy or continuous therapy and not reasonable and necessary. It is expected that the time between treatment episodes should allow for assessment, both clinically and by one or more standard rating scales, to clearly document that the patient responded and then relapsed. The number of retreatments is not limited at this time. However, frequent reporting of services may trigger focused medical reviews.

All other uses of TMS therapy are investigational and/or experimental and are not covered.

Routine performance of motor threshold re-determination during rTMS therapy will be considered not reasonable and necessary. More than three motor threshold redeterminations in a rolling six-month period will be denied.  Denied claims may be appealed with supporting documentation addressing the medical necessity (e.g. when there is a change in clinical status or medical regimen that is expected to alter cortical excitability).

Place of Service (POS) Provider Qualifications

Medicare considers TMS therapy reasonable and necessary when it is furnished in accordance with the accepted standards of medical practice, when it is furnished in a setting appropriate to the patient’s medical needs and condition, when it meets but does not exceed the patient’s medical need and when it is ordered and furnished by qualified personnel.

It is expected that TMS therapy will be ordered by a psychiatrist familiar with this therapy and furnished under the direct supervision of a qualified physician (MD or DO) as follows: 

Direct Supervision- To be covered incident to the services of a physician, services and supplies must be furnished by the physician or by auxiliary personnel under the physician’s direct supervision. In the office setting, this means the physician must be present in the office suite and immediately available to furnish assistance and direction throughout the performance of the procedure. It does not mean that the physician must be present in the room when the procedure is performed.  

NOTE:  For additional information on the CMS requirements for direct physician supervision, please refer to CMS IOM pub. 100-02, Chapter 15, Section 60 for services and supplies furnished incident to a physician’s professional service. 

Qualified Physicians (MD or DO) must possess evidence of knowledge, training and expertise to perform TMS services.  

Qualified Physician and/or Prescribing Physician expectations are as follows:

The attending physician who prescribes a treatment course of TMS (psychiatrist), which involves a medical device, is ultimately responsible for the overall daily management of the TMS treatment team.  It is expected that the prescribing physician (psychiatrist) establish the anticipated clinical treatment plan based on assessment of the patient’s clinical history and review this treatment plan with the patient prior to beginning the course of treatment. 

It is expected that the prescribing physician or another physician in the practice should perform the initial motor threshold determination and identify the appropriate coil location for subsequent treatments.  Subsequent motor threshold determinations may be delegated by the attending physician to another, appropriately qualified physician or member of the clinical staff.  In this circumstance, the qualified physician must be available on-site.

The qualified physician should review the clinical course of each daily treatment session to determine whether any modifications to the subsequent daily treatment should occur.  It is expected that the qualified physician will provide appropriate documentation supporting the medical necessity of the services and that such documentation be made available upon request. 

Conduction and oversight of daily treatment sessions may be delegated by the attending physician to another qualified physician or member of the clinical staff but must be furnished under direct physician supervision.

TMS Training Requirements for Qualified Physicians and Personnel

Peer-to-peer and graduate medical education have an important role in physician and staff training.  In addition to industry sponsored training that is device specific, it is expected that TMS providers complete additional training either through a university affiliated or industry independent Continuous Medical Education (CME) program or through additional peer-to-peer direct supervision.

Providers with a strong foundation in TMS through their training or extensive TMS experience may be exempt from the above expectation (i.e. Psychiatrist). 

It is also expected that the attending physician and all staff who are members of the TMS treatment team receive appropriate product training on the use of this technology.  It is expected that at a minimum, the TMS team receive the detailed product training offered by the device manufacturer and maintain written documentation of training. 

Non-physician operators should also undergo manufacturers’ training prior to independently performing treatments.  TMS is a medically complex treatment and, therefore, emergency medical services must be accessible at all times.  The operator should provide updates, progress notes or both every day that should be monitored by the prescribing physician.  The use of repeated ratings with mood scales to document depression changes is expected. 

It is expected that all TMS clinical staff maintain appropriate training to support their role as first responders to potential medical emergencies.

It is expected that a TMS clinic establish formal standard operating procedures (SOPs) related to training and ongoing criteria to maintain procedural skills for all staff who are involved in the delivery of TMS in the office setting.  Documentation of implementation and adherence to these procedures must be included and made available upon request.

For frequency limitations please refer to the Utilization Guidelines section below.

Level of Evidence

Levels of evidence were determined by placing the greatest emphasis on evidence obtained from randomized controlled trials and systematic reviews of randomized controlled trials. (Levels 1 and 2).

Level 3 includes systematic reviews of level 3 studies or controlled individual cases. 

Level 4 includes case series.

Level 5 includes anecdotal evidence or non-human animal-based evidence

Levels of Evidence framework published by the University of Oxford Centre for Evidence-Based Medicine.

Evidence in support of left prefrontal, fast rTMS.

Multi-site randomized controlled trials (RCT) – Level 1

Three large, multisite, randomized sham-controlled trials included an aggregate sample of 703 adult patients with major depressive disorder (MDD) who had failed between 1 and 4 antidepressant trials.

Two of the studies were industry sponsored registration trials for the NeuroStar TMS Therapy System [O’Reardon, et al. (2007)] and the Brainsway Deep TMS device in 2013 [Levkovitz, et al. (2015)]. The third study was a National Institute of Mental Health (NIMH) - sponsored, multicenter study, which provided industry-independent evidence of TMS effects on depression [George, et al. (2010)]. This NIMH trial used an active, sham-controlled condition and the primary outcome focused on the clinically important endpoint of remission. All three trials were consistent in their evidence, establishing a statistically significant and clinically relevant benefit with TMS therapy compared to the sham condition.

Evidence for durability of acute treatment with rTMS

The level of evidence for the durability of rTMS treatment is lower than the above.  There is lack of uniformity of the population studied as some are on medication and some are not, follow up times vary and bias may be introduced by failure to account for what happened to those who dropped out of the studies.  In a study by Dunner, et al, involving a one-year, multi-site, naturalistic, observational cohort conducted in 120 patients who met criteria for response or remission after their acute TMS course, 62% continued to meet response criteria 12 months later [28]. The results of these studies in patients placed back on antidepressant medications demonstrates high (i.e. 64–90%) durability for acute TMS benefits over a 3–12 month-period, with a majority of patients who relapsed responding to additional TMS sessions.

Evidence for continuation/maintenance studies:

Data is scant and only a small number of patients were included to support continuation/maintenance therapy.

Maintenance is defined by the Clinical TMS Society as a course that begins after the end of C-TMS (continuation) and is intended to prevent recurrence of an episode (a new episode). The only published controlled trial to date of continuation TMS was performed in the Brainsway multicenter trial. MDD patients (N=212) were randomized to sham or active TMS during the acute 4-week treatment phase followed by a continuation phase of 2 treatments a week for an additional 12 weeks. At the end of the continuation phase (week 16), the difference in remission rates between TMS (31.8%) and sham (22.2%) were not significant (p=0.15).

Provider and Staff Qualifications

These are in keeping with the guidelines of the Clinical TMS Society recommendations.

Overall Conclusions Based on Summary of Evidence

The efficacy and safety of TMS using a specific, defined treatment protocol in treatment resistant depression was confirmed in 3 trials as listed above and all three studies are consistent in their conclusion that support TMS as applied in routine clinical practice settings. There is some reasonable data to support retreatment but not maintenance or continuation treatments. Defining the number of treatment failures as one or two is consistent with longstanding evidence but often inconsistently applied across studies.  According to recent assessments by the Agency for Healthcare Research and Quality, more consistent measures of improvement in responses are needed. Finally, several professional organizations have included TMS in their guidelines as recommended acute treatment for major depression, along with suggested qualifications of professionals involved in treatment. 

Documentation Requirements

1. All documentation must be maintained in the patient’s medical record and available to the contractor upon request.

2. Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service(s)). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.

3. The submitted medical record must support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code must describe the service performed.

4. The medical record documentation must support the medical necessity of the services as directed in this policy.

5. The attending physician must monitor and document the patient's clinical progress during treatment. The clinical record must document that the attending physician met with the patient face to face for the initial assessment and subsequent delivery and management and when there has been a change in either the clinical or mental status of the patient. The attending physician must use evidence-based validated depression monitoring scales such as the Geriatric Depression Scale (GDS), the Personal Health Questionnaire Depression Scale (PHQ-9), the Beck Depression Scale (BDI), Hamilton Rating Scale for Depression (HAM-D), the Montgomery Asberg Depression Rating Scale (MADRS), the Quick Inventory of Depressive Symptomatology (QIDS) or the Inventory for Depressive Symptomatology Systems Review (IDS-SR) to monitor treatment response and the achievement of remission of symptoms.

Utilization Guidelines

The treatment must be provided by use of a device approved by the FDA for the purpose of supplying Transcranial Magnetic Stimulation.

It is expected that the services would be performed as indicated by current medical literature and standards of practice. Services performed in excess of established parameters may be subject to review for medical necessity.

TMS is reasonable and necessary for up to 30 treatment sessions over a 7-week period followed by 6 treatment sessions for tapering for those in remission. Further treatment of an episode of depression beyond this, for patients who have not achieved at least a 50% reduction in symptoms will be considered not medically reasonable and necessary and not subject to coverage.

Retreatment may be considered for patients who met the guidelines for initial treatment and subsequently developed relapse of depressive symptoms if the patient responded to prior treatments as evidenced by a greater than 50% improvement in standard rating scale measurements for depressive symptoms or if there were a relapse after remission (e.g., (GDS), PHQ-9, BDI, HAM-D, MADRS, QIDS or IDS-SR score). A repeat treatment program is allowed as above.

Therapeutic repetitive transcranial magnetic stimulation (TMS) treatment; subsequent motor threshold re-determination with delivery and management, is considered reasonable and necessary when there is a change in clinical status or medical regimen that is expected to alter cortical excitability. The medical record must clearly document the rationale for the performance of a motor threshold re-determination. Routine performance of motor threshold re-determination during rTMS therapy will be considered not reasonable and necessary.

More than three motor threshold re-determinations in a rolling six-month period will be denied.  Denied claims may be appealed with supporting documentation addressing the medical necessity (e.g. when there is a change in clinical status or medical regimen that is expected to alter cortical excitability or there is a demonstrated need for an episode of retreatment).  The medical record must clearly document the rationale for the motor threshold re-determination.

See Bibliography

1. Allan CL, Herrmann LL, Ebmeier KP. Transcranial Magnetic Stimulation in Management of Mood Disorders. Neuropsychobiology. 2011;64(3)163-9. [Met-analysis]
2. Avery DH, Isenberg KE, Sampson SM, et al. Transcranial magnetic stimulation in the acute treatment of major depression: clinical response in an open-label extension trial. J Clin Psychiatry 2008; 69(3):441-451
3. Burt T, Lisanby SH, Sackeim HA: Neuropsychiatric applications of transcranial magnetic stimulation: a meta analysis. Int J Neuropsychopharmacol 2002; 5:73–103 [E]
4. Carpenter LL, Janicak PG, Aaronson ST, et al. Transcranial Magnetic Stimulation (TMS) for Major Depression: A Multisite, Naturalistic, Observation Study of Acute Treatment Outcomes in Clinical Practice Depression and Anxiety. 2012;29:587-596.
5. Caufield, K.A.m et,al.  Antidepressant Effect of Low Frequency Right-Sided rTMS in Two Patients With Left Frontal Stroke.  Brain Stimul. 2017; Jan-Feb;10(1): 150-151.
6. Connolly RK, Helmer A, Cristancho MA, O’Reardon JP. Effectiveness of transcranial magnetic stimulation in clinical practice post-FDA approval in the United States: results observed with the first 100 consecutive cases of depression at an academic medical center. J Clin Psychiatry. 2012;73:e567–e573. [Study for Philadelphia clinic, again showing effectiveness as an adjunctive treatment to antidepressant medications in the first 100 patients treated at their university-based TMS clinical service following FDA approval.]
7. Couturier JL: Efficacy of rapid-rate repetitive transcranial magnetic stimulation in the treatment of depression: a systematic review and meta-analysis. J Psychiatry Neurosci 2005; 30:83–90 [E]
8. Dannon PN, Dolberg OT, Schreiber S, Grunhaus L: Three and six-month outcome following courses of either ECT or rTMS in a population of severely depressed individuals—preliminary report. Biol Psychiatry 2002; 51:687–690 [A−]
9. Dunner DL, Aaronson ST, Sackeim HA, et al. A multisite, naturalistic, observational study of transcranial magnetic stimulation for patients with pharmacoresistant major depressive disorder: durability of benefit over a 1-year follow-up period. J Clin Psychiatry. 2014 Dec;75(12):1394-401
10. Eranti S, Mogg A, Pluck G, Landau S, Purvis R, Brown RG, Howard R, Knapp M, Philpot M, Rabe-Hesketh S, Romeo R, Rothwell J, Edwards D, McLoughlin DM: A randomized, controlled trial with 6-month follow-up of repetitive transcranial magnetic stimulation and electroconvulsive therapy for severe depression. Am J Psychiatry 2007; 164:73–81 [A–]
11. Fitzgerald PB, Grace N, Hoy KE, et al. An Open Label Trial of Clustered Maintenance rTMS for Patients with Refractory Depression. Brain Stimulation 2013;6(3):292-297.
12. Fregni F, Marcolin MA, Myczkowski M, et al. Predictors of antidepressant response in clinical trials of transcranial magnetic stimulation. Int J Neuropsychopharmacol. 2006; 9:641–654.
13. Gaynes BN, Lux LJ, Lloyd SW, et al. Comparative Effectiveness Review Number 33. Effective Health Care Program. Nonpharmacologic Interventions for Treatment-Resistant Depression in Adults  AHRQ Publication No. 11-EHC056-EF. Rockville, MD: Agency for Healthcare Research and Quality. September 2011. (The evidence for ECT was good, TMS vs sham was moderate and all others insufficient.) Accessed 1/20/2015.
14. George MS, Lisanby SH, Avery D, et al. Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder. A sham-controlled randomized trial. Arch Gen Psychiatry 2010; 60(5)507-516.
15. George MS, Taylor JJ, Short EB. The expanding evidence base for rTMS treatment of depression. Curr Opin Psychiatry. Jan 2013;26:13-8. [Review]
16. George MS, Wassermann EM, Williams WE, et al. Mood improvements following daily left prefrontal repetitive transcranial magnetic stimulation in patients with depression: a placebo-controlled crossover trial. Am J Psychiatry. 1997;154:1752–1756. [Early study with preliminary evidence.]
17. Gross, M, Nakamura L, Pascual-Leone A, et al. Has Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment for Depression Improved? A systematic Review and Meta-analysis Comparing the Recent vs. The Earlier rTMS Studies. Acta Psychiatr Scand.2007; 116(3): 165-173.
18. Herrmann LL, Ebmeier KP: Factors modifying the efficacy of transcranial magnetic stimulation in the treatment of depression: a review. J Clin Psychiatry 2006; 67:1870–1876 [E]
19. Herwig U, Fallgatter AJ, Hoppner J, Eschweiler GW, Kron M, Hajak G, Padberg F, Naderi-Heiden  A, Abler B, Eichhammer P, Grossheinrich N, Hay B, Kammer T, Langguth B, Laske C, Plewnia C, Richter MM, Schulz M, Unterecker S, Zinke A, Spitzer M, Schonfeldt-Lecuona Antidepressant effects of augmentative transcranial magnetic stimulation: randomised multicentre trial. Br J Psychiatry 2007; 191:441–448 [A]
20. Janicak PG, Dowd SM, Martis B, et al. Repetitive transcranial magnetic stimulation versus electroconvulsive therapy for major depression: preliminary results of a randomized trial. Biol Psychiatry. 2002; 51:659–667.
21. Janicak PG, Dunner DL, Aaronson ST, et al. Transcranial magnetic stimulation (TMS) for major depression: a multisite, naturalistic, observational study of quality of life outcome measures in clinical practice. CNS Spectr. 2013 Dec;18(6):322-32.
22. Janicak PG, Nahas Z, Lisanby SH, et al. Durability of clinical benefit with transcranial magnetic stimulation (TMS) in the treatment of pharmacoresistant major depression: assessment of relapse during a 6-month, multisite, open-label study. Brain Stimul. 2010 Oct;3(4):187-99.
23. Janicak PG, O’Reardon JP, Sampson SM, et al. Transcranial magnetic stimulation in the treatment of major depressive disorder: a comprehensive summary of safety experience from acute exposure, extended exposure, and during reintroduction treatment. J Clin Psychiatry. 2008 Feb;69(2):222-32
24. Jorge RE, Moser DJ, Acion L, Robinson RG: Treatment of vascular depression using repetitive transcranial magnetic stimulation. Arch Gen Psychiatry 2008; 65:268–276 [A]
25. Kozel FA, George MS: Meta-analysis of left prefrontal repetitive transcranial magnetic stimulation (rTMS) to treat depression. J Psychiatr Pract 2002; 8:270–275 [E]
26. Lam RW, Chan P, Wilkins-Ho M, et al. Repetitive transcranial magnetic stimulation for treatment-resistant depression: a systematic review and metaanalysis. Can J Psychiatry 2008; 53:621-631.
27. Lisanby SH, Husain MM, Rosenquist PB, et al. Daily Left Prefrontal Repetitive Transcranial Magnetic Stimulation in the Acute Treatment of Major Depression: Clinical Predictors of Outcome in a Multisite, Randomized Controlled Clinical Trial. Neuropsychopharmacology. 2009; 34(2): 522-34.
28. Mantovani A, Pavlicova M, Avery D, et al. Long-term efficacy of repeated daily prefrontal transcranial magnetic stimulation (TMS) in treatment-resistant depression. Depress Anxiety. 2012;29:883–890. [The effects appear durable, at least at 3 and 6 months.]
29. Martin JL, Barbanoj MJ, Schlaepfer TE, Clos S, Perez V, Kulisevsky J, Gironell A: Transcranial magnetic stimulation for treating depression. Cochrane Database Syst Rev 2002; CD003493 [E]
30. Martin JL, Barbanoj MJ, Schlaepfer TE, Thompson E, Perez V, Kulisevsky J: Repetitive transcranial magnetic stimulation for the treatment of depression. Systematic review and meta-analysis. Br J Psychiatry 2003; 182:480–491 [E]
31. McDonald WM, Durkalski V, Ball ER, et al. Improving the antidepressant efficacy of transcranial magnetic stimulation: maximizing the number of stimulations and treatment location in treatment-resistant depression. Depress Anxiety. 2011;28:973-980. [Open-label extension of the OPT-TMS randomized trial showed that about 30% of patients remit, but that in many this can take up to 6 weeks of therapy.
32. O’Reardon JP, Solvason HB, Janicak PG, et al. Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry. 2007;62(11):1208-1216.
33. Perera T, George MS, Grammer G, et al. The Clinical TMS Society Consensus Review and Treatment Recommendations for TMS Therapy for Major Depressive Disorder. Brain Stimul. 2016; 9(3):336-46.
34. Pridmore S: Substitution of rapid transcranial magnetic stimulation treatments for electroconvulsive therapy treatments in a course of electroconvulsive therapy. Depress Anxiety 2000; 12:118–123 [B]
35. Rosa MA, Gattaz WF, Pascual-Leone A, et al. Comparison of repetitive transcranial magnetic stimulation and electroconvulsive therapy in unipolar non-psychotic refractory depression: a randomized, single-blind study. Int J Neuropsychopharmacol. 2006; 9:667–676.
36. Rush, AJ, Trivedi MH et al. Acute and longer-term outcomes in depressed outpatients requiring one of several treatment steps: a STAR*D report. Am J Psychiatry 2006;163(11) 1905-1917.
37. Schulze-Rauschenbach SC, Harms U, Schlaepfer TE, Maier W, Falkai P, Wagner M: Distinctive neurocognitive effects of repetitive transcranial magnetic stimulation and electroconvulsive therapy in major depression. Br J  Psychiatry 2005; 186:410–416 [B]
38. Schutter DJ. Antidepressant efficacy of high frequency transcranial magnetic stimulation over the left dorsolateral prefrontal cortex in double-blind sham controlled designs: a meta-analysis. Psychol Med 2009; 39:65-75
39. Other Contractor's LCDs