Transcranial magnetic stimulation: a historical evaluation and future prognosis of therapeutically relevant ethical concerns

Transcranial Magnetic Stimulation (TMS) is a non-invasive neurostimulatory and neuromodulatory technique increasingly used in clinical and research practices around the world. Historically, the ethical considerations guiding the therapeutic practice of TMS were largely concerned with aspects of subject safety in clinical trials. While safety remains of paramount importance, the recent US Food and Drug Administration approval of the Neuronetics NeuroStar TMS device for the treatment of specific medication-resistant depression has raised a number of additional ethical concerns, including marketing, off-label use and technician certification. This article provides an overview of the history of TMS and highlights the ethical questions that are likely arise as the therapeutic use of TMS continues to expand.

[1]  Robert G. Heath,et al.  Septal stimulation for the initiation of heterosexual behavior in a homosexual male , 1972 .

[2]  R. Heidel,et al.  Reducing the Health Consequences of Smoking: 25 Years of Progress. A Report of the Surgeon General. , 1989 .

[3]  T. Brismar,et al.  Hearing loss from the acoustic artifact of the coil used in extracranial magnetic stimulation , 1990, Neurology.

[4]  Á. Pascual-Leone,et al.  Transcranial magnetic stimulation in patients with epilepsy , 1991, Neurology.

[5]  Á. Pascual-Leone,et al.  Induction of speech arrest and counting errors with rapid‐rate transcranial magnetic stimulation , 1991, Neurology.

[6]  J Valls-Solé,et al.  Safety of rapid-rate transcranial magnetic stimulation in normal volunteers. , 1993, Electroencephalography and clinical neurophysiology.

[7]  M. Jurchack Preventive ethics: expanding the horizons of clinical ethics. , 1994, Journal of Clinical Ethics.

[8]  M. Hallett,et al.  Responses to rapid-rate transcranial magnetic stimulation of the human motor cortex. , 1994, Brain : a journal of neurology.

[9]  B. Waller,et al.  Individual autonomy and the double-blind controlled experiment: the case of desperate volunteers. , 1995, Journal of Medicine and Philosophy.

[10]  Andreas Hufnagel,et al.  Transcranial magnetic stimulation (TMS) in the treatment of major depression — a pilot study , 1995 .

[11]  P. Brown Shocking safety concerns , 1996, The Lancet.

[12]  Á. Pascual-Leone,et al.  Rapid-rate transcranial magnetic stimulation of left dorsolateral prefrontal cortex in drug-resistant depression , 1996, The Lancet.

[13]  Á. Pascual-Leone,et al.  Ethical guidelines for rTMS research. , 1997, IRB.

[14]  E. Wassermann Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation, June 5-7, 1996. , 1998, Electroencephalography and clinical neurophysiology.

[15]  D. Satcher Mental Health: A Report of the Surgen General , 1999 .

[16]  T. Marrelli Mental health: A report of the surgeon general , 2000 .

[17]  E. Topol,et al.  Risk of cardiovascular events associated with selective COX-2 inhibitors. , 2001, JAMA.

[18]  Sarah H Lisanby,et al.  Therapeutic application of repetitive transcranial magnetic stimulation: a review , 2001, Clinical Neurophysiology.

[19]  F. Miller,et al.  A critique of clinical equipoise. Therapeutic misconception in the ethics of clinical trials. , 2003, The Hastings center report.

[20]  Á. Pascual-Leone,et al.  Transcranial magnetic stimulation in neurology , 2003, The Lancet Neurology.

[21]  H. Brody,et al.  Therapeutic Misconception in the Ethics of Clinical Trials. (A Critique of Clinical Equipoise) , 2003 .

[22]  Ziad Nahas,et al.  Handbook of Transcranial Magnetic Stimulation , 2003 .

[23]  André Parent,et al.  Giovanni Aldini: From Animal Electricity to Human Brain Stimulation , 2004, Canadian Journal of Neurological Sciences / Journal Canadien des Sciences Neurologiques.

[24]  Bartha Maria Knoppers,et al.  Human genetic research: emerging trends in ethics , 2006, Nature Reviews Genetics.

[25]  Bartha Maria Knoppers,et al.  Human Genetic Research: Emerging Trends in Ethics , 2006 .

[26]  S. Cramer,et al.  BDNF val66met polymorphism is associated with modified experience-dependent plasticity in human motor cortex , 2006, Nature Neuroscience.

[27]  Á. Pascual-Leone,et al.  Noninvasive human brain stimulation. , 2007, Annual review of biomedical engineering.

[28]  William W. McDonald,et al.  Efficacy and Safety of Transcranial Magnetic Stimulation in the Acute Treatment of Major Depression: A Multisite Randomized Controlled Trial , 2007, Biological Psychiatry.

[29]  Brian N. Pasley,et al.  Transcranial Magnetic Stimulation Elicits Coupled Neural and Hemodynamic Consequences , 2007, Science.

[30]  Alvaro Pascual-Leone,et al.  Cumulative sessions of repetitive transcranial magnetic stimulation (rTMS) build up facilitation to subsequent TMS‐mediated behavioural disruptions , 2008, The European journal of neuroscience.

[31]  Felipe Fregni,et al.  Bartholow, Sciamanna, Alberti: Pioneers in the Electrical Stimulation of the Exposed Human Cerebral Cortex , 2008, The Neuroscientist : a review journal bringing neurobiology, neurology and psychiatry.

[32]  William M. Stern,et al.  An open-label, prospective study of repetitive transcranial magnetic stimulation (rTMS) in the long-term treatment of refractory depression: reproducibility and duration of the antidepressant effect in medication-free patients. , 2008, The Journal of clinical psychiatry.

[33]  F. Fregni,et al.  Risk factors for relapse after remission with repetitive transcranial magnetic stimulation for the treatment of depression , 2009, Depression and anxiety.

[34]  S. Rossi,et al.  Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research , 2009, Clinical Neurophysiology.

[35]  L. Harris,et al.  Probing the human brain with stimulating electrodes: The story of Roberts Bartholow’s (1874) experiment on Mary Rafferty , 2009, Brain and Cognition.

[36]  Sarah H Lisanby,et al.  Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial. , 2010, Archives of general psychiatry.