Off-Label Promotion of Transcranial Magnetic Stimulation on Provider Websites

Wexler, Anna; Nagappan, Ashwini; Kopyto, Deena; Santarnecchi, Emiliano; Pascual‐Leone, Álvaro

doi:10.1016/j.brs.2021.04.013

Cited by 4 publications

(6 citation statements)

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“…TBS treatment is approximately three minutes compared to the standard 40-minute session in TMS treatments [ 7 ]. TBS produces a similar efficacy of treatment when compared to traditional TMS and may decrease the number of patients lost to follow-up [ 8 ]. The FDA has approved the use of TMS in the treatment of major unipolar depression and obsessive-compulsive disorder [ 1 ].…”

Section: Introductionmentioning

confidence: 99%

“…The FDA has approved the use of TMS in the treatment of major unipolar depression and obsessive-compulsive disorder [ 1 ]. However, TMS is used as an off-label treatment modality in a plethora of other indications, including post-traumatic stress disorder, bipolar disorder, fibromyalgia, Parkinson’s disease, tinnitus, multiple sclerosis, schizophrenia, and more [ 8 ]. Though there is a significant effect seen in the treatment of mood disorders such as major depressive disorder, there is also a relapse rate of up to 30% [ 9 ].…”

Section: Introductionmentioning

confidence: 99%

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Transcranial Magnetic Stimulation in Bipolar II Disorder Treatment: A Case Report

Tran,

Hutto,

Thompson

et al. 2023

Cureus

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The objective of this case report is to describe and document the use of transcranial magnetic stimulation (TMS) to aid in the treatment of bipolar II disorder. A 35-year-old male with a past medical history of attention-deficit/hyperactivity disorder (ADHD), post-traumatic stress disorder (PTSD), severe depression, and bipolar II disorder was presented to an outpatient psychiatric clinic 1.5 years after his initial TMS treatment for TMS maintenance therapy. He reported feeling depressed, brain fogginess, loss of concentration, fatigue, and constant changes in moods. He had tried multiple antidepressants and antipsychotics, seen several therapists, and underwent electroconvulsive therapy in 2014 with no improvement. In August 2021, he underwent the standard TMS protocol with 36 treatments and noticed significant improvement in his symptoms. He followed up with his psychiatrist who placed him on quetiapine 400 mg, lurasidone 120 mg, topiramate 100 mg, Adderall 20 mg, Wellbutrin 150 mg, propranolol 20 mg, and Klonopin 0.5 mg for management. However, after starting these medications, he noticed a loss of concentration, not being able to think straight, fatigue, depression, and a change in moods. In January 2023, the patient underwent maintenance TMS treatment with theta bursts (TBS). The treatment protocol consisted of 10 sessions for 3 ½ minutes each, 20 trains, 10 bursts, and eight seconds between intervals. He completed his treatment and reported feeling great and like himself again. Two weeks following treatment, he reported that his brain fog had resolved, hypomanic episodes had lessened, and depressive moods had been occurring less often. Due to improvement, topiramate and lurasidone were discontinued and the patient will continue with monthly follow-ups to monitor his progress. TMS appears to be a promising treatment option for bipolar disorder.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Transcranial Magnetic Stimulation in Bipolar II Disorder Treatment: A Case Report

Tran,

Hutto,

Thompson

et al. 2023

Cureus

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“…A recent report by Wexler and colleagues [ 19 ] analyzed promotion of TMS on provider websites. While device manufacturers cannot legally promote TMS for off-label indications, providers don’t have such legal restrictions.…”

Section: Introductionmentioning

confidence: 99%

“…A search of the information on TMS therapy on the internet provides a glimpse into contrasting “hype and hope” and “gloom and doom” perspectives ([ 21 ], at p. 69) that have such a distorting potential. At this interaction point, the existence of multiple novel forms of TMS blurs the line between research and therapy and can increase risks due to TMS-drug interactions, comorbidities, and unknowns about prevalence of (serious) adverse effects and side effects as elucidated by the FDA [ 19 ].…”

Section: Introductionmentioning

confidence: 99%

The public impact of academic and print media portrayals of TMS: shining a spotlight on discrepancies in the literature

2022

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Background Transcranial magnetic stimulation (TMS) is an FDA approved treatment for major depression, migraine, obsessive compulsive disorder, and smoking addiction. TMS has gained popular media support, but media coverage and commercial reporting of TMS services may be contributing to the landscape of ethical issues. Methods We explore the differences between the academic and print media literature portrayals of TMS to evaluate their ethical impact for the public. We performed a comprehensive literature review using PubMed and NexisUni databases to evaluate the literature available on TMS from 2014 to 2019. Our sample consisted of 1632 academic articles and 468 print media articles for a total of 2100 articles. We then coded each article for seven specific top-level codes: (1) type of source, (2) year of publication, (3) purpose of TMS application, (4) age of subjects, (5) population, (6) overall tone, and (7) specification of TMS parameters. We also made some additional notes of the TMS parameters where specified and the breakdown of mental health applications. Results Our results indicated several discrepancies between the academic and the print media reporting about TMS technology, particularly with regards to tone and specificity. Namely, the academic sample was largely neutral and specific about the parameters under which TMS was being applied, while the print media sample was heavily optimistic and presented the application of TMS with far less specificity. There was some convergence between the two samples, such as the focus of both on therapy as the predominant TMS application. Conclusions We call upon the academic community to increase scrutiny of TMS services in order to ensure that people’s knowledge of health technologies is not unduly influenced by sensational claims and a general lack of adequate information.

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“…Any approval of psychedelic treatments will come against the background of an already-burgeoning landscape of private neurotherapy and brain wellness clinics that promote the off-label use of psychiatric drugs and medical devices . For example, more than 100 clinics in the US advertise the use of transcranial magnetic stimulation for off-label indications; some of the advertised indications have a weaker body of evidence supporting efficacy than others . Hundreds of other clinics offer alternative neurotherapies that lack a strong evidence base, such as neurofeedback, for both clinical indications as well as for “cognitive enhancement.” Furthermore, off-label ketamine use is promoted by clinics for a variety of clinical indications as well as for “wellness” and “inner exploration.” Many of these same clinics are poised to begin offering psychedelics if and when they garner FDA approval…”

mentioning

confidence: 99%

Brain Wellness “Spas”—Anticipating the Off-label Promotion of Psychedelics

Wexler

Sisti

2022

JAMA Psychiatry

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Psychedelic drugs have reemerged as a promising adjunct to psychotherapy for a variety of mental health indications. Recent phase 3 clinical studies indicate 3,4methylenedioxymethamphetamine (MDMA) is both efficacious and well tolerated in the treatment of posttraumatic stress disorder. 1 Psilocybin-naturally found in mushrooms-appears in phase 2 studies to be efficacious in treating depression. The US Food and Drug Administration (FDA) has designated both as breakthrough therapies, fast-tracking them for approval. 2 Commercial interest has surged, with dozens of companies investing in psychedelic drug development in what is predicted to be a multibillion-dollar market. 3 If and when psychedelics are approved by the FDA, they will almost certainly be used not just for their approved indication(s) but for off-label ones as well. The influence of underground and spiritual healers may also promptoff-labeloralternativeuseswithinthemedicalcontext. When supported by evidence, off-label use can benefit patients by increasing access to safe treatments. In this Viewpoint, however, we raise concerns about ethical and legal issues related to the public promotion and advertisement of psychedelics for off-label indications.Any approval of psychedelic treatments will come against the background of an already-burgeoning landscape of private neurotherapy and brain wellness clinics that promote the off-label use of psychiatric drugs and medical devices. 4 For example, more than 100 clinics in the US advertise the use of transcranial magnetic stimulation for off-label indications; some of the advertised indications have a weaker body of evidence supporting efficacy than others. 5 Hundreds of other clinics offer alternative neurotherapies that lack a strong evidence base, such as neurofeedback, for both clinical indica-

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Off-Label Promotion of Transcranial Magnetic Stimulation on Provider Websites

Cited by 4 publications

References 4 publications

Transcranial Magnetic Stimulation in Bipolar II Disorder Treatment: A Case Report

Transcranial Magnetic Stimulation in Bipolar II Disorder Treatment: A Case Report

The public impact of academic and print media portrayals of TMS: shining a spotlight on discrepancies in the literature

Brain Wellness “Spas”—Anticipating the Off-label Promotion of Psychedelics

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