Deep transcranial magnetic stimulation

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Deep transcranial magnetic stimulation

Deep transcranial magnetic stimulation (Deep TMS) is a non-invasive technique that can induce increases or decreases in excitability of large populations of neurons in deep areas of the brain.[1] Deep TMS is used for the treatment of drug-resistant major depressive disorder, without the need for hospitalization or anesthesia.[2] There is tentative evidence to support its use in this condition.[2]

Medical use[edit]

Depression[edit]

Deep TMS has shown promise as an add-on to antidepressants for the treatment of unipolar and bipolar depressive relapses in small studies, although it is not a mainstream therapy.[3]

Safety[edit]

Deep TMS is a relatively new technique and all experiments, for any disorder, also test the safety of the method as part of the approved experimental protocol. So far, Deep TMS has been shown to be generally safe and tolerable, presenting some minor side effects.[2]

Design[edit]

Deep TMS utilizes the basic principles of TMS but expands them from the use of a single focal stimulation source to a summation of several simultaneous operating elements.[2] Deep TMS coils (termed H-coils) can overcome disadvantages of other coils, such as their inability to induce deep stimulation without over-stimulation of cortical regions and facial nerves.[4] To achieve that:

  • Coils include a flexible base shaped to fit the human head. The base, which is the part of the coil closest to the head, must be optimally fitted to the scalp at the desired region.
  • The wires leading currents in a direction opposite to the preferred direction (the return paths) should be located far from the base and the desired brain region. This enables a higher absolute electric field in the desired brain region.
  • The induced electric field in the desired deep brain region is obtained by optimal summation of electric fields, induced by several coil elements with common direction locations around the skull.
  • Coils must be positioned to produce a considerable field in a direction tangential to the surface, which should also be the preferable direction to activate the relevant neuronal structures (considering the direction of the targeted neuronal bundles).[2][4][5]

To affect different areas of the brain (depending on the targeted disorder), specific versions of H-coils are installed within a helmet placed on the subject's head. For example, the H1-coil induces greater stimulation over the left prefrontal cortex (PFC); the H2-coil induces bilateral stimulation over the PFC; and the Haut-coil induces bilateral stimulation over the medial PFC.[2]

Efficacy[edit]

dTMS is a continuation of the same idea as rTMS (Repetitive Transcranial Magnetic Stimulation), but with the hope that deeper stimulation of subcortical areas of the brain leads to increased effect.[6] A 2015 systematic review and health technology assessment found lacking evidence in order to recommend the method over either ECT or rTMS because so few studies had been published.[6]

Sham TMS coils[edit]

In sham-controlled clinical TMS studies, which test the placebo effect of the treatment, both patients and operators should be "blinded" to the type of stimulation (i.e., active or a sham treatment). However, it is difficult to perform rTMS treatment in a double blind design because the person delivering the TMS can easily become aware of the treatment condition.[7] In the Deep TMS system used for clinical trials, the sham coil is placed inside the same helmet encasing the active TMS coil, and electronic system controls which of the two coils is connected to the stimulator in a certain session.[4] The operation is performed by a magnetic card specific to each patient. This way both the patient and the operator may be unaware of the operation mode.[4] The sham coil mimics sound and scalp sensations induced by the active coil without having any stimulating activity.[2]

History[edit]

Deep TMS technology is a type of transcranial magnetic stimulation developed by Abraham Zangen and Yiftach Roth starting in 2001, and a patent was filed by the American National Institutes of Health (NIH, US 2004078056 ). In January 2013, the United States Food and Drug Administration permitted the manufacturer to market a Deep TMS device that was indicated for the treatment of depressive episodes in adult patients suffering from major depressive disorder who failed to achieve satisfactory improvement from previous anti-depressant medication treatment in the current episode.[8]

Deep TMS was tested for a variety of disorders, including, bipolar disorder, addiction, posttraumatic stress disorder, Parkinson's disease, and schizophrenia with a typical protocol consisting of 15-20 sessions, each lasting 15–20 minutes, over a course of 3–4 weeks.[2]

Approval[edit]

Brainsway, a company that markets Deep TMS, said in January 2013 that it had USA FDA approval for treating major depressive disorder with Deep TMS.[9]

In the European Economic Area, various versions of Deep TMS H-coils has CE marking for:

Research[edit]

Traumatic brain injury (TBI)[edit]

Deep TMS has shown mixed results in the treatment of cognitive and motor deficits from traumatic brain injury.[12]

Stroke[edit]

Deep TMS has been used in stroke patients, where it has shown mixed results in improving motor symptoms.[12]

Parkinson's and Alzheimer's diseases[edit]

Deep TMS has shown promise in the treatment of Parkinson's and Alzheimer's diseases, although rigorous clinical trials are lacking.[13]

References[edit]

  1. ^ Hovington CL, McGirr A, Lepage M, Berlim MT (2013). "Repetitive transcranial magnetic stimulation (rTMS) for treating major depression and schizophrenia: a systematic review of recent meta-analyses". Ann Med. 45 (4): 308–21. PMID 23687987. doi:10.3109/07853890.2013.783993. 
  2. ^ a b c d e f g h Bersani FS; Minichino A; Enticott PG; et al. (January 2013). "Deep transcranial magnetic stimulation as a treatment for psychiatric disorders: a comprehensive review". Eur. Psychiatry (Review). 28 (1): 30–9. PMID 22559998. doi:10.1016/j.eurpsy.2012.02.006. 
  3. ^ Rapinesi, C; Bersani, FS; Kotzalidis, GD; Imperatori, C; Del Casale, A; Di Pietro, S; Ferri, VR; Serata, D; Raccah, RN; Zangen, A; Angeletti, G; Girardi, P (2015). "Maintenance Deep Transcranial Magnetic Stimulation Sessions are Associated with Reduced Depressive Relapses in Patients with Unipolar or Bipolar Depression". Frontiers in neurology. 6: 16. PMC 4321576Freely accessible. PMID 25709596. doi:10.3389/fneur.2015.00016. 
  4. ^ a b c d Roth Y, Zangen A (2012). "Basic Principles and Methodological Aspects of Transcranial Magnetic Stimulation". In Miniussi C, Paulus W, Rossini PM. Transcranial Brain Stimulation. Boca Raton, FL: CRC Press. 
  5. ^ Roth Y, Padberg F, Zangen A (2007). "Transcranial magnetic stimulation of deep brain regions: principles and methods". In Marcolin MA, Padberg F. Transcranial Brain Stimulation for Treatment of Psychiatric Disorders. 23. Basel: Karger. pp. 204–225. 
  6. ^ a b Services, Statens beredning för medicinsk och social utvärdering (SBU); Swedish Agency for Health Technology Assessment and Assessment of Social. "Effekter av djup transkraniell magnetstimulering med H-spole". www.sbu.se (in Swedish). Retrieved 2017-06-02. 
  7. ^ Aleman A (August 2013). "Use of Repetitive Transcranial Magnetic Stimulation for Treatment in Psychiatry". Clin Psychopharmacol Neurosci (Review). 11 (2): 53–59. PMC 3766755Freely accessible. PMID 24023548. doi:10.9758/cpn.2013.11.2.53. 
  8. ^ Krauthamer, V (2013-01-07). "Letter to Brainsway, Ltd." (PDF). 510(k)Summary for K12288: Brainsway Deep TMS System. Silver Spring, Maryland: Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration. Retrieved 2013-11-20. 
  9. ^ "FDA approves Brainsway's depression treatment device". Globes. January 9, 2013. Archived from the original on December 16, 2013. Retrieved December 16, 2013. 
  10. ^ a b c "Brainsway reports positive Deep TMS system trial data for OCD". Medicaldevice-network. September 6, 2013. Retrieved December 16, 2013. 
  11. ^ a b c d e f "Brainsway’s Deep TMS EU Cleared for Neuropathic Chronic Pain". medGadget. July 3, 2012. Retrieved December 16, 2013. 
  12. ^ a b Shin, SS; Dixon, CE; Okonkwo, DO; Richardson, RM (November 2014). "Neurostimulation for traumatic brain injury.". Journal of Neurosurgery. 121 (5): 1219–31. PMID 25170668. doi:10.3171/2014.7.JNS131826. 
  13. ^ Hansen, N (2014). "Brain stimulation for combating Alzheimer's disease". Frontiers in neurology. 5: 80. PMC 4040449Freely accessible. PMID 24917846. doi:10.3389/fneur.2014.00080.