![]() | Medical Policy |
| Subject: | Transcranial Magnetic Stimulation for Non-Behavioral Health Indications | ||
| Policy #: | MED.00108 | Current Effective Date: | 01/01/2012 |
| Status: | Reviewed | Last Review Date: | 11/17/2011 |
| Description/Scope |
Transcranial magnetic stimulation (TMS) involves placement of a small coil over the scalp through which a rapidly alternating current, producing a magnetic field, is passed unimpeded through the cranium and scalp. This document addresses the use of TMS as a treatment for non-behavioral health indications.
Note: Please see the following related document for additional information concerning TMS for behavioral health and neuropsychiatric indications:
| Position Statement |
Investigational and Not Medically Necessary:
Transcranial magnetic stimulation (TMS) of the brain is considered investigational and not medically necessary for all non-behavioral health indications, including but not limited to, treatment of:
| Rationale |
TMS is a non-invasive technique that consists of a magnetic field emanating from a wire coil held outside the head. The magnetic field induces an electrical current in specific cortical regions of the brain to either increase or decrease the excitability of the affected brain structures depending on the applied stimulation parameters (i.e. frequency, intensity, pulse duration, stimulation site).
Transcranial Magnetic Stimulation for the Treatment of Tinnitus
Transcranial magnetic stimulation has been proposed as a treatment for chronic tinnitus that is associated with increased focal brain activity in the central auditory system. Kleinjung and colleagues (2005) reported on a small prospective, placebo-controlled, crossover study of low frequency (1Hz) rapid repetitive transcranial magnetic stimulation (rTMS) in 14 right-handed individuals with chronic tinnitus. Using the Magstim® Nerve Stimulator (The Magstim Company LTD, Woburn, MA, U.S.A.), rTMS was applied to an area of increased focal metabolic activity in the auditory cortex identified with fused positron emission tomography (PET-MR) imaging. After one week of rTMS, 11 of 14 individuals experienced a significant reduction in tinnitus (p<0.0005) but no significant change for placebo treatment (p=0.336). Eight participants reported reduced tinnitus six months after treatment. The authors concluded that the preliminary study results are promising, but the study size is small and further investigation is needed to establish the efficacy and safety of rTMS in the treatment of tinnitus.
In a randomized, double-blind, sham-controlled crossover trial (n=16), Rossi and colleagues (2007) utilized low frequency (1Hz) rTMS over the auditory associated cortex (left temporoparietal region) for participants that met the following inclusion criteria: unilateral or bilateral tinnitus for more than one year, normal neurological examination and normal cranial magnetic resonance. Participants were randomly assigned to receive active (n=8) or sham (n=6) rTMS as the first intervention. Each week of the intervention was followed by two weeks of observation. Clinical variables were sampled immediately after the end of active or sham treatment, and after weeks one and two. The crossover occurred after the first two weeks of observation. The authors reported that sham treatment resulted in a less than 10% improvement in visual analogue score (VAS) over the three-week assessment. The average improvement in VAS for active rTMS (about 35%) was maintained for one week following treatment. Of the 14 participants who completed the study, eight (57%) were classified as responders (25% or greater improvement in VAS); no baseline factors were found to be associated with a positive response. Two participants dropped out due to worsening of tinnitus. Limitations of this study include the small sample size, participant dropout rate (n=2, 12%), and the lack of long-term follow-up.
Another small randomized sham controlled study (n=8) found a temporary (30 minutes or less) duration-dependent reduction in tinnitus in about 50% of subjects following a single 5 minute, 15 minute or 30 minute session of rTMS over temporoparietal areas associated with excessive tinnitus-related activity (guided by PET with and without intravenous lidocaine). In this study, the authors concluded that the response to treatment was negatively correlated (r=-0.62) with disease duration (Plewnia, 2007).
Kleinjung and colleagues (2007) conducted a prospective observational study (n=45) of low-frequency rTMS delivered in ten sessions to the left primary auditory cortex (identified by magnetic resonance imaging [MRI]) in individuals with chronic tinnitus. Treatment outcome was assessed with a tinnitus questionnaire. Of the participants, 40% were classified as responders (five points or more on the tinnitus questionnaire) and 60% as nonresponders; improvement in symptoms was maintained for 90 days. Post-hoc analysis found that a positive response was associated with absence of a hearing impairment and disease duration of less than three years. The authors concluded that tinnitus-related neuroplastic changes may be less pronounced in subjects with normal hearing and a short history of complaints, explaining why those individuals benefited more from rTMS treatment.
In a comparative pilot study, Kleinjung and colleagues (2008) proposed the use of low-frequency rTMS of the temporal cortex as a new treatment strategy for individuals with chronic tinnitus. The authors stated that a functional abnormality in individuals with tinnitus involves multiple brain structures used for attention and emotional processing, including the dorsolateral prefrontal cortex. Therefore, the authors suggested the use of a new rTMS treatment strategy consisting of a combination of high-frequency prefrontal and low-frequency temporal rTMS for these individuals. Thirty-two participants received either low-frequency temporal rTMS or a combination of high-frequency prefrontal and low-frequency temporal rTMS. Treatment effects were assessed with a standardized tinnitus questionnaire (TQ). The authors reported that during and immediately after stimulation, there was a significant reduction of the tinnitus score in both groups (p=0.016), however, no significant difference between the two stimulation protocols (p=0.828) was observed. An evaluation after three months suggested a "tendency toward tinnitus improvement" with a significant difference (p=0.08) between the two treatment conditions, including a more pronounced effect for the combined protocol (p=0.029). The authors concluded that these results support recent data that suggest that auditory and nonauditory brain areas are involved in tinnitus pathophysiology. However, as these conclusions were drawn from a pilot study without placebo controls, randomized controlled trials of larger populations are necessary to determine the safety and efficacy of combination therapy consisting of high-frequency prefrontal and low-frequency temporal rTMS for the treatment of tinnitus.
A randomized controlled trial by Khedr and colleagues (2008) compared the effect of different frequencies of rTMS (1 Hz, 10 Hz, 25 Hz and sham; occipital, 1 Hz), given daily over the left temporoparietal cortex for two weeks to 66 subjects (randomly divided into four treatment groups) with chronic tinnitus. Subjects were assessed using the Tinnitus Handicap Inventory (THI) scale, performing self-ratings of symptoms and audiometric measures of residual inhibition before, immediately after two weeks of treatment, and monthly thereafter for four consecutive months. The authors reported there were no significant differences in basal measures between the four groups of subjects. A two-factor ANOVA analysis revealed a significant "rTMS" x "time" interaction for all measures; this occurred because real rTMS produced greater improvement than sham. However, there was no significant difference between the responses to different frequencies of rTMS. The response to rTMS depended on the duration of tinnitus, as subjects who had tinnitus for the longest period were the least likely to respond to treatment. The authors concluded that daily sessions of rTMS over the temporoparietal cortex may be a useful treatment for tinnitus.
Marcondes and colleagues (2009) authored a small (n=19) randomized, double-blind, sham-controlled parallel trial with six-month follow-up after rTMS. As earlier studies had showed improved outcomes in the absence of hearing impairment, only subjects with normal pure tone audiometry were included in this trial. Five sessions of rTMS (17 minutes per session) were performed on five consecutive days. Placebo stimulation was performed with a sham coil system that mimics the sound of active stimulation, without producing a magnetic field. Tinnitus severity on the THI scale showed a decrease from baseline (29.8) to one-month (19.4) and six-month (22.8) follow-up. There was no change in the THI following sham stimulation (28.9 at baseline, 28.9 at one month, and 29.6 at six months). At six-month follow-up, 40% of subjects receiving rTMS had a reduction greater than 10 points in the THI, compared to 22% after sham rTMS. There was a modest decrease in the mean VAS for tinnitus loudness for active rTMS, and some differences between groups in objectively measured changes in blood flow in the temporal and limbic lobes with single-photon emission computed tomography (SPECT) imaging. Although these longer-term results are encouraging, additional studies with a larger number of subjects are needed to adequately evaluate the efficacy of this treatment.
Anders and colleagues (2010) published results of a randomized, double-blind, sham-controlled trial with 42 participants who had chronic, treatment-resistant tinnitus and completed two weeks of rTMS treatment over the left primary auditory cortex. An additional 10 participants withdrew from the study before the end of treatment due to adverse effects such as headache, worsening of tinnitus or perceived lack of efficacy. Tinnitus severity was measured at baseline, the end of treatment (week 2), and during follow-up at 6, 14, and 26 weeks. The baseline THI was 37.1 for the active treatment and 26.5 for the sham treatment. At the end of the stimulation phase, both active and sham groups showed a significant reduction in the symptoms of tinnitus, as measured by the THI and tinnitus questionnaire. In the active rTMS group, tinnitus severity with the THI was rated as 31.8 at week 2, increasing to around 33 through the 26 weeks of follow-up. In the sham group, the THI was 23.1 at week 2, rising to 27.7 by 26 weeks. A similar pattern was observed with the tinnitus questionnaire. Interpretation of this study is limited due to the differences in baseline scores and improvement in the sham group immediately following treatment. In addition, the clinical significance of a four-point change in the THI and three-point change in the tinnitus questionnaire is unclear.
Piccirillo and colleagues (2011) examined the effectiveness and safety of low-frequency rTMS in a double-blind, randomized, crossover clinical trial of 14 adults with subjective, unilateral or bilateral, nonpulsatile tinnitus of six months duration or longer and a score of 38 or greater on the THI. Low-frequency (1-Hz) 110% motor threshold rTMS or sham treatment was administered to the left temporoparietal junction for two weeks. The primary outcome measure was the difference in the change of the THI score between active and sham rTMS. The results indicated that active treatment was associated with a median (95% CI) reduction in THI score of 5 (0-14) points compared to sham treatment which was associated with a median reduction in THI score of 6 (-2 to 12) points. The difference in THI scores between the change associated with active and sham rTMS ranged from a 34-point reduction in THI score after active treatment to a 22-point increase after sham treatment, with a median difference change of only one point (-6 to 4 points). The investigators concluded that active rTMS was no more effective than sham treatment, citing possible explanations for the negative findings as the "short duration of treatment, failure of rTMS stimulation over the temporoparietal area to affect the auditory cortex buried within the Sylvian fissure, or more widespread cortical network changes associated with severe bothersome tinnitus not amenable to localized rTMS effects."
Despite the suggested benefit of rTMS reported in some of the peer-reviewed literature, sufficient evidence is lacking from larger scale randomized controlled trials comparing rTMS with placebo therapies that demonstrates a durable outcome benefit of rTMS therapy for the treatment of tinnitus.
The American Academy of Audiology's (AAA) Audiologic Guidelines for the Diagnosis & Management of Tinnitus Patients (AAA, 2000), states that "prior to recommending or beginning any treatment for tinnitus, it is essential that a differential diagnosis be attempted. There are many factors that can cause and affect tinnitus and its perception that will influence the management plan and outcome of any treatment." The evaluation and "treatment of patients with tinnitus is most likely to succeed when a multidisciplinary approach is employed." The AAA states, "That at this time there is no cure for most cases of tinnitus," however, "a number of treatment approaches that can be performed by audiologists have been described with various degrees of reported success."
Transcranial Magnetic Stimulation for Other Non-Behavioral Health Indications
A number of case series, cohort studies, prospective and retrospective single and double-blind randomized controlled trials, a Cochrane review, and a meta-analysis have explored the efficacy of TMS for other non-behavioral, neurodegenerative, and neurophysiologic conditions, including treatment of symptoms associated with acute ischemic stroke (Khaleel, 2010; Khedr, 2010), amyotrophic lateral sclerosis (ALS) (Di Lazzaro, 2010; Dileone, 2010), chronic hyperacusis (Zazzio, 2010), chronic and neuropathic pain syndromes including fibromyalgia (Leung, 2009; O'Connell, 2010; Picarelli, 2010; Sampson, 2011), focal dystonia (including benign essential blepharospasm) (Havrankova, 2010; Kranz, 2010; Schneider, 2010), focal or refractory partial epilepsy (Brodbeck, 2010; Sun, 2011), Huntington's disease (HD) (Medina, 2010), migraine headache (Clarke, 2006; Lipton 2010; Teepker, 2010), pain related to seizures associated with epilepsia partialis continua (Rotenberg, 2009), Parkinson's disease (bradykinesia, rigidity, tremor, vocal function) (Hamada, 2009; Hartelius, 2010; Filipović, 2010), post-stroke aphasia (Kakuda, 2010a), post-stroke hemiparesis, motor recover, and spasticity (Chang, 2010; Emara, 2010; Kakuda, 2010b; Kakuda, 2010c; Koganemaru, 2010; Lim, 2010), smell and taste dysfunction (Henkin, 2011), spasticity associated with spinal cord injury (Kumru, 2010) and Tourette's syndrome (Kwon, 2011). Methodological limitations in a number of these studies include a small sample size, absence of a placebo control group, presence of concurrent pharmacotherapy, and lack of long-term outcome measures.
Two small, randomized, double-blind placebo-controlled trials investigated the safety and efficacy of rTMS and intermittent theta-burst stimulation (iTBS) (a novel type of rTMS) in the treatment of motor symptoms in Parkinson's disease. Benninger and colleagues (2011) treated 26 individuals with mild to moderate Parkinson's disease with iTBS of the motor and dorsolateral prefrontal cortices in eight sessions over two weeks (13 iTBS and 13 sham stimulation). Assessment of safety and clinical efficacy over a one-month period included timed tests of gait and bradykinesia, Unified Parkinson's Disease Rating Scale (UPDRS), and additional clinical, neuropsychological, and neurophysiologic measures. The investigators reported that iTBS improves mood and was safe, but failed to improve gait, upper extremity bradykinesia, UPDRS, or other motor symptoms. The second trial conducted by Arias and colleagues (2010) evaluated the effect of low-frequency rTMS on motor signs in 18 individuals randomly assigned to receive either active (n=9) or sham (n=9) rTMS for 10 days. The effect of the stimulation was evaluated through several gait variables, hand dexterity, and the total and motor sections of the UPDRS. Total and motor section of the UPDRS and the turn time during gait were the only measures affected by the stimulation, with treatment effect appearing during either 'ON' or 'OFF' evaluation; however, this effect was equally displayed in both active and sham treatment groups. The remaining measures were not influenced by the treatment. The investigators concluded "the protocol of stimulation used, different from most protocols that apply larger amount of stimuli, but very similar to some previously reported to have excellent results, has no therapeutic value and should be abandoned. This contrasts with the positive reported effects using higher frequency and focal coils. Our work also reinforces the need for sham stimulation when evaluating the therapeutic effect of rTMS."
The durability of rTMS and its role in improving health outcomes in the treatment of these conditions is unknown. Further randomized controlled trials comparing TMS to placebo therapy are needed to determine the net health benefit of TMS as treatment for these non-behavioral health indications.
| Background/Overview |
TMS was first introduced in 1985 as a method of noninvasive stimulation of the brain. The technique involves placement of a small coil over the scalp; a rapidly alternating current is passed through the coil wire, producing a magnetic field that passes unimpeded through the cranium and scalp. TMS was initially used to investigate nerve conduction when TMS over the motor cortex of the brain was noted to produce a muscle-evoked response on the opposite side.
Tinnitus describes the perception of any sound in the ear in the absence of an external stimulus and represents a malfunction in the processing of auditory signals; hearing impairment, often noise-induced or related to aging, is commonly associated with tinnitus. Almost everyone at one time or another has experienced brief periods of mild ringing or other sound in the ear. Some individuals have more annoying and constant types of tinnitus. One third of all adults report experiencing tinnitus at some time in their lives. Ten percent to 15% of adults have prolonged tinnitus requiring medical evaluation (Heller, 2003). Prevalence estimates of individuals with tinnitus vary widely, from 7.9 million to more than 37 million (Noell, 2003). Clinically, tinnitus is subdivided into subjective and objective; the latter describes a very small minority of cases in which an external stimulus is potentially heard by an observer, for example, by placing a stethoscope over the individual's external ear. Common causes of objective tinnitus include middle ear and skull-based tumors, vascular tumors and malformations, and contractions of the palatal muscles. Treatment of objective tinnitus is dictated by the identified underlying disorder.
Distinguishing between objective and subjective tinnitus is essential to its successful diagnosis and management. In the majority of cases, tinnitus is subjective and frequently self-limited. In a small subset of individuals with subjective tinnitus, its persistence leads to disruption of daily life. While many individuals adjust to tinnitus, others may seek medical care if the tinnitus becomes too disruptive. Data from the American Tinnitus Association (2011) points to a prevalence of tinnitus in about 50 million Americans. Between 0.5% and 3% of the adult population may suffer from severe chronic tinnitus that can seriously affect their normal lives by producing mood disorders, anxiety, depression, or altered sleep (Anderson, 2004). Tinnitus can occur as an isolated symptom without a recognizable cause or in association with middle or inner ear disease such as sensorineural hearing loss, otosclerosis, drug-related toxicity (antimicrobials, chemotherapeutic agents, loop diuretics, nonsteroidal anti-inflammatory [NSAIDs], or salicylates), sudden deafness and Ménierè's disease. Environmental factors include acute acoustic trauma, exposure to occupational noise, and overly amplified music. Other causes of subjective tinnitus include neurological events or disorders (head injury, vestibular schwannoma), infectious processes (otitis media, meningitis), or conditions such as temporomandibular joint (TMJ) disorder. Psychological and psychosocial conditions such as depression, phonophobia, and social isolation may accompany tinnitus symptoms. Treatment of subjective tinnitus is supportive in nature; no single treatment has been demonstrated as an effective cure. Multiple pharmacotherapies have been tried to treat tinnitus including lidocaine, antidepressants, anticonvulsants, anxiolytics, antihistamines, antioxidants, herbs, vitamins, and minerals.
Devices for transcranial stimulation have received U.S. Food and Drug Administration (FDA) approval for diagnostic uses. At the current time, the FDA has not cleared or approved for marketing any TMS device for treatment purposes other than depression.
| Definitions |
Hyperacusis: Abnormally acute hearing due to heightened irritability of the sensory neural mechanism.
Objective tinnitus: Internal sounds that may be audible to an observer with a stethoscope or other auscultation device placed over the head and neck structures near the individual's ear.
Subjective tinnitus: The false perception of noise that is heard only by an individual in the absence of acoustic stimulation of the cochlea.
Tinnitus: A perception of sound in the head when no outside sound is present; typically referred to as "ringing in the ears" or "head noise," but other forms of sound have been described such as hissing, roaring, pulsing, whooshing, chirping, whistling and clicking.
Transcranial magnetic stimulation (TMS): Involves placement of a small coil over the scalp through which a rapidly alternating current, producing a magnetic field, is passed unimpeded through the cranium and scalp; magnetic pulses are delivered one at a time in single-pulse TMS (sTMS) or as a train of pulses in repetitive TMS (rTMS).
| Coding |
The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.
When services are Investigational and Not Medically Necessary:
When the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.
| CPT | |
| 90867 | Therapeutic repetitive transcranial magnetic stimulation treatment; initial, including cortical mapping, motor threshold determination, delivery and management |
| 90868 | Therapeutic repetitive transcranial magnetic stimulation treatment; subsequent delivery and management, per session |
| 90869 | Therapeutic repetitive transcranial magnetic stimulation (TMS) treatment; subsequent motor threshold re-determination with delivery and management |
| ICD-9 Diagnosis | |
| All non-behavioral health diagnoses |
| References |
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
| Web Sites for Additional Information |
| Index |
Repetitive Transcranial Magnetic Stimulation (rTMS)
Single-Pulse Transcranial Magnetic Stimulation (sTMS)
Tinnitus
Transcranial Magnetic Stimulation (TMS)
The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.
| Document History |
| Status | Date | Action |
| Reviewed | 11/17/2011 | Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Rationale and References. Updated Coding section with 01/01/2012 CPT changes; removed 0160T, 0161T deleted 12/31/2010. |
| New | 11/18/2010 | MPTAC review. Initial document development. |