Talk:Transcranial magnetic stimulation/Archive 2

Magnetic water treatment
I added this link to a controversial science article, as the mechanism within the blood chemistry may be similar: could it be that the magneto-mechanical action works on the blood to precipitate obstructive placa which is then carried by the blood to be fairly rapidly processed and presumably excreted in urine or excrement, who knows? I doubt that the magnetic field has much effect on the neurones, since we humans have lived in an electro-magnetic soup for almost a century without noticing much change other than obesity - but of course this is only my speculation - does it help, perhaps?

— Preceding unsigned comment added by Timpo (talk • contribs) 09:14, 22 January 2014

Corrections based on FDA Wikipedia guidelines
Dear User:Doc James,User:Corker1

I'd like to make a couple of edits that meet recent US government FDA wikipedia guidelines. These edits have been verified and approved by a legal as well as a medical team to ensure they meet the recent government guidelines. The medical and legal review teams agreed and concluded that the current state of the page does not represent neutral views. Please let us know if you have any objections for the following changes. Neutral references are provided or available for all proposed edits. Appreciate your input.

Thank you. --WikiCorrect-Health (talk) 20:07, 28 October 2014 (UTC)


 * NOTE - I went through and reformatted the content below last night into subsections and added edit requests. Formerly it looked like this Jytdog (talk) 17:43, 16 November 2014 (UTC)

1) Introduction section
Original Text:

Because this type of pulse generally does not reach further than two inches into the brain, scientists can select which parts of the brain will be affected and which will not be. The magnetic field is about the same strength as that of a magnetic resonance imaging (MRI) scan." A variant of TMS, repetitive transcranial magnetic stimulation (rTMS), has been tested as a treatment tool for various neurological and psychiatric disorders including migraine, stroke, Parkinson's disease, dystonia, tinnitus and depression.

Proposed Text:

Because this type of pulse generally does not reach further than two inches into the brain, scientists can select which parts of the brain will be affected and which will not be. The magnetic field is about the same strength as that of a magnetic resonance imaging (MRI) scan. Single pulse TMS has been cleared by the FDA to relieve pain caused by migraine headaches. A variant of TMS, repetitive transcranial magnetic stimulation (rTMS), has been cleared by the FDA for the treatment of Major Depressive Disorder. Repetitive transcranial magnetic stimulation is still being studied as a treatment tool for various other neurological and psychiatric disorders including stroke, Parkinson's disease, dystonia, and tinnitus.

reference 1: http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm378608.htm

reference 2: "K133408: 510(k) Summary: Neuronetics NeuroStar® TMS Therapy System" (pdf). U.S. Department of Health and Human Services: Food and Drug Administration: Center for Devices and Radiological Health. 2014-03-28. p. 2. Archived from the original on 2014-07-23. Retrieved 2014-07-23. WikiCorrect-Health (talk) 20:07, 28 October 2014 (UTC)
 * not done. i did rewrite the lead however. Jytdog (talk) 02:18, 2 January 2015 (UTC)

2) Risks - Updated introduction paragraph
To be added as the first paragraph of the risks section: TMS is generally regarded as safe. The greatest acute risk is the rare occurrence of induced seizures. In 1998, a conference was held to establish safety parameters for TMS. Since the establishment of these guidelines, there have been 16 reports of TMS-related seizures (as of 2009), with seven reported before the publication of safety guidelines in 1998[2], and nine reported afterwards[1]. The seizures are primarily associated with rTMS, although they have been reported following single-pulse TMS. Reports have stated that, in at least some cases, predisposing factors (medication, brain lesions or genetic susceptibility) may have contributed to the seizure. A review of nine seizures associated with rTMS that had been reported after 1998 stated that four seizures were within the safety parameters, four were outside of those parameters, and one had occurred in a healthy volunteer with no predisposing factors. A 2009 international consensus statement on TMS that contained this review concluded that based on the number of studies, subjects, and patients involved with TMS research, the risk of seizure with rTMS is considered very low.

References: reference_source_1: Rossi, S; Hallett, M; Rossini, PM; Pascual-Leone, A; Safety of TMS Consensus Group (2009). "Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research". Clinical Neurophysiology 120 (12): 2008–2039. doi:10.1016/j.clinph.2009.08.016. PMC 3260536.

reference_source_2:

Wassermann, EM (1998). "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". Electroencephalography and Clinical Neurophysiology/Evoked Potentials Section 108: 1–9. doi:10.1016/S0168-5597(97)00096-8.

WikiCorrect-Health (talk) 20:07, 28 October 2014 (UTC)
 * response: this drills down into a data in a way that we do not do, and reference 2 is sixteen years old'.  it is in the article now and is coming out  Jytdog (talk) 05:57, 16 November 2014 (UTC)

3) Risks - Modified second paragraph
Original Text:

A comprehensive safety study of rTMS in the treatment of major depression looked at three separate groups totalling over 300 patients. It found that rTMS was associated with a low incidence of side effects, most of which were mild to moderate. Additionally, only 4.5% of patients discontinued their participation during acute treatment because of adverse events. Modified Text:

A comprehensive safety study of rTMS in the treatment of major depression looked at three separate groups totalling over 300 patients. It found that rTMS was associated with a low incidence of side effects, most of which were mild to moderate. The most common side effect observed was discomfort or pain from the stimulation of the scalp and associated nerves and muscles on the overlying skin. Additionally, 4.5% of patients discontinued their participation during acute treatment because of adverse events.

reference_source_1: Janicak, PG; O'Reardon, JP; Sampson, SM; Husain, MM; Lisanby, SH; Rado, JT; Heart, KL; Demitrack, MA (2008). "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". The Journal of clinical psychiatry 69 (2): 222–32. doi:10.4088/jcp.v69n0208. WikiCorrect-Health (talk) 20:07, 28 October 2014 (UTC)
 * response. both the original text and the proposed text are not OK.  per WP:MEDMOS we don't drill down into the data this way.  am fixing this based on the published reviews. Jytdog (talk) 05:56, 16 November 2014 (UTC)

4) Therapeutic Use - Introduction
Original Text:

Studies of the use of TMS and rTMS to treat many neurological and psychiatric conditions have generally shown only modest effects with little confirmation of results. However, reviews have stated that rTMS appeared to be effective in the treatment of certain types of major depression under certain specific conditions.

Modified Text:

Studies of the use of TMS and rTMS to treat neurological and psychiatric conditions have been conducted. Recent meta-analyses of the use of rTMS have shown “level A or B evidence supports an efficacy of rTMS protocols in depression, pain, motor stroke and schizophrenia." "Numerous studies have shown that repetitive transcranial magnetic stimulation (rTMS) produced significant clinical effects in patients with various neurological and psychiatric disorders."

reference_source_1:

Lefaucheur, JP; André-Obadia, N; Antal, A; Ayache, SS; Baeken, C; Benninger, DH; Cantello, RM; Cincotta M; de Carvalho, M; De Ridder, D; Devanne, H; Di Lazzaro, V; Filipović, SR; Hummel, FC; Jääskeläinen, SK; Kimiskidis, VK; Koch, G; Langguth, B; Nyffeler, T; Oliviero, A; Padberg, F; Poulet, E; Rossi, S; Rossini, PM; Rothwell, JC; Schönfeldt-Lecuona, C; Siebner, HR; Slotema, CW, Stagg, CJ, Valls-Sole, J; Ziemann, U; Paulus, W; Garcia-Larrea, L (2014). "Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS)". Clinical Neurophysiology. doi:10.1016/j.clinph.2014.05.021. . WikiCorrect-Health (talk) 20:07, 28 October 2014 (UTC)
 * see above Jytdog (talk) 07:17, 16 November 2014 (UTC)

5) Therapeutic Use - Addition of Second Paragraph
TMS Therapy has gained general acceptance as a safe and proven treatment for major depression. The American Psychiatric Association’s (APA) 2010 Practice Guidelines for the Treatment of Patients with Major Depressive Disorder state that, “for patients whose symptoms have not responded adequately to medication…transcranial magnetic stimulation could also be considered…”. Additionally, in 2009 the Canadian Network for Mood and Anxiety Disorders and the World Federation of Societies for Biological Psychiatry both independently concluded there is now sufficient Level 1 evidence to support the use of TMS as an acute treatment for major depression. More recently, the Royal Australia and New Zealand College of Psychiatrists endorsed the evidence base substantiating the clinical importance of TMS as a treatment option for patients with major depressive disorder (2013).

reference_source_1: American Psychiatric Association (2010). (eds: Gelenberg, AJ, Freeman, MP, Markowitz, JC, Rosenbaum, JF, Thase, ME, Trivedi, MH, Van Rhoads, RS). Practice Guidelines for the Treatment of Patients with Major Depressive Disorder, 3rd Edition.

reference_source_2:

Kennedy, SH, Milev, R, Giacobbe, P, Ramasubbu, R, Lam, RW, Parikh, SV, Patten, SB, Ravindran, AV. (2009) Canadian Network for Mood and Anxiety Treatments (CANMAT) Clinical guidelines for the management of major depressive disorder in adults. IV. Neurostimulation therapies. J Aff Disorders 117:S44-S53. reference_source_3: Schlaepfer, T. E., M. S. George, et al. (2009). WFSBP Guidelines on Brain Stimulation Treatments in Psychiatry. The World Journal of Biological Psychiatry 1: 1-17.; The Royal Australian and New Zealand College of Psychiatrists. (2013) Position Statement 79. Repetitive Transcranial Magnetic Stimulation. Practice and Partnerships Committee WikiCorrect-Health (talk) 20:07, 28 October 2014 (UTC)
 * see above Jytdog (talk) 07:17, 16 November 2014 (UTC)

6) Therapeutic Use - Modification of second (as per current structure) paragraph
Original Text:

A meta-analysis of 34 studies comparing rTMS to sham treatment for the acute treatment of depression found that rTMS was effective with an effect size of 0.55. This is comparable to commonly reported effect of medications for treatment of depression in the range of 0.17-0.46. However, this meta-analysis found that rTMS was worse than electroconvulsive therapy (ECT), although there were significantly fewer adverse effects with rTMS. An analysis of one of the studies included in the meta-analysis found that one extra remission from depression occurred for every 3 people given electroconvulsive therapy rather than rTMS.

Modified Text:

A meta-analysis of 34 studies comparing rTMS to sham treatment for the acute treatment of depression found that rTMS was effective with an effect size of 0.55 (p<.001). This is comparable to commonly reported effect sizes of pharmacotherapeutic strategies for treatment of depression in the range of 0.17-0.46. However, this meta-analysis found that ECT yields more favorable results then TMS. Although rTMS cannot replace ECT in depressive patients, there may be subgroups in which rTMS can replace antidepressant medication. The article concluded that, “rTMS deserves a place in the standard toolbox of psychiatric treatment methods, as it is effective for depression and AVH and has a mild side effect profile.”

reference_source_1: Slotema, C. W.; Blom, J. D.; Hoek, H. W.; Sommer, I. E. C. (2010). "Should We Expand the Toolbox of Psychiatric Treatment Methods to Include Repetitive Transcranial Magnetic Stimulation (rTMS)?". The Journal of Clinical Psychiatry 71 (7): 873–884. doi:10.4088/JCP.08m04872gre. .

WikiCorrect-Health (talk) 20:07, 28 October 2014 (UTC)
 * no - we don't drill down like this. Jytdog (talk) 07:11, 16 November 2014 (UTC)

7) FDA Actions - Depression - Paragraph 1
Original Text:

In January 2007, an advisory panel of the United States Food and Drug Administration (FDA) did not recommend clearance for marketing of an rTMS device, stating that the device appeared to be reasonably safe but had failed to demonstrate efficacy in a study of people with major depression who had not benefitted from prior adequate treatment with oral antidepressants during their current major depressive episode. The panel agreed that "unblinding was greater in the active group, and considering the magnitude of the effect size, it may have influenced the study results." However, the FDA determined in December 2008 that the rTMS device was sufficiently similar to existing devices that did not require a premarket approval application and allowed the device to be marketed in accordance with Section 510(k) of the Federal Food, Drug, and Cosmetic Act In March 2014, the FDA cleared this device "for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode".

Modified Text:

The FDA cleared the first rTMS device in the US for the treatment of major depression in 2008 via the de novo reclassification process described in Section 513 (f)(2) of the Federal Food, Drug, and Cosmetic Act.(1) Through de novo reclassification, lower risk medical devices for which no marketed predicate device exists, are cleared for marketing based on safety and efficacy data submitted for that device. For the rTMS device, these data were the results of an industry-sponsored multi-center randomized controlled trial (DEN070003/K061053).(2) The results of a second, industry-independent randomized controlled trial (3) resulted in an expanded FDA clearance for this device for major depression to include patients with a broad range of treatment resistance (K133408).

reference_source_1: http://www.accessdata.fda.gov/cdrh_docs/pdf8/K083538.pdf

reference_source_2: O'Reardon, J.P., Solvason, H.B., et al. (2007) Efficacy and safety of Transcranial Magnetic Stimulation in the acute treatment of major depression: A multisite randomized controlled trial. Biol Psychiatry, 62:1208-1216.

reference_source_3: George, M. S., Lisanby, S. H., et al. (2010) Daily Left Prefrontal Transcranial magnetic Stimulation Therapy for Major Depressive Disorder: A Sham-Controlled Randomized Trial. Arch Gen Psychiatry 76(5): 507 - 516. In the public domain: http://archpsyc.ama-assn.org/cgi/content/full/67/5/507.

reference_source_4: http://www.accessdata.fda.gov/cdrh_docs/pdf13/K133408.pdf
 * WikiCorrect-Health (talk) 20:07, 28 October 2014 (UTC)
 * we need to write this in plain English. Not sure the original article should have the level of detail that it does... there is much about this article that is not well done.    Jytdog (talk) 07:14, 16 November 2014 (UTC)

discussion
Interesting. So who is funding these proposed changes? Additionally it is not clear which references you plan to use. Doc James (talk · contribs · email) (if I write on your page reply on mine) 05:01, 29 October 2014 (UTC)


 * Dear User:Doc James,


 * The specific edits are not funded by any specific organization. But collectively we gathered the information from IMS Health medical team after we received requests from the industry as part of our WikiCorrect-Health project workshops. This as a result of US Government(FDA) providing guidelines to the manufactures to fix misinformation and biases on Wiki pages. The references have been incorporated in the comments as they already have been provided in the page by previous authors.  --WikiCorrect-Health (talk) 15:43, 29 October 2014 (UTC)


 * A few of these refs are not appropriate including scholarpedia and the 1985 lancet pager But agree they are long standing. Doc James  (talk · contribs · email) (if I write on your page reply on mine) 22:54, 29 October 2014 (UTC)


 * So you have proposed adding this "Single pulse TMS has been cleared by the FDA to relieve pain caused by migraine headaches[1]." with this as the ref Which text in the ref supports the text in question?  Doc James  (talk · contribs · email) (if I write on your page reply on mine) 03:58, 30 October 2014 (UTC)


 * Dear User:Doc James,
 * Here is the correct reference for the change "Single pulse TMS has been cleared by the FDA to relieve pain caused by migraine headaches".  Also I have provided the links for the references under each proposed change above to avoid confusion.
 * I made a mistake with the links below. Sorry about that.
 * WikiCorrect-Health (talk) 01:36, 4 November 2014 (UTC)


 * Dear User:Doc James,
 * Can you please let me know your thoughts on my comments above? I have updated the references under each proposed change. Removed thelancet.com and scholarpedia references.
 * WikiCorrect-Health (talk) 16:34, 5 November 2014 (UTC)


 * Note, WikiCorrect went ahead and made the edit in this dif. I reverted the edit.  The edits disregarded WP:MEDMOS and were made by an editor or editors under an account with a username violation, which also appears to be violating the Terms of Use with regard to paid editing.  None of that is OK.  The edits were also done in one massive change, which is not acceptable way to edit Wikipedia.  It leaves other editors with little choice but to revert en masse.  Which I have done.  Jytdog (talk) 01:14, 14 November 2014 (UTC)

FDA Actions/Depression Section
The article gives the following timeline:
 * 1) In 2007 the Advisory Committee recommends against approval based on potential unblinding.
 * 2) The FDA approves the device anyway based on 510(k) pathway (this approval is actually for major depression)
 * 3) In March 2014, the Agency " cleared the device for treatment of Major Depressive Disorder..." (The actual approval was for "major depression in adults patients who have failed to benefit from one more prior antidepressant medications in the current episode")
 * 4) "Soon after the FDA cleared the device " Public Citizen writes a letter to the editor hypothesizing that the FDA used post hoc analysis as a basis of approval and that the approval should not have happened.

This seems misleading to me in several regards.
 * The 2007 approval was for Major Depression and the 2014 for treatment resistant major depression per the sources cited. The text appears to be incorrect.
 * We have contaminated the entire evidence bed with the idea that these trials are not really blinded based on a 7 year old conclusion about trials run 8 or more years ago, but there is a 2013 meta analysis stating that this is probably not the case.
 * We've contaminated the 2014 FDA approval for treatment resistant depression with a hypothesis from Public Citizen that can't possibly be true for chronological reasons. According to the cited reference, approval in 2014 occurred on the basis of NCT00149838, which according to clinicaltrials.gov, concluded in April 2009.  The Public Citizen letter was received by the journal Neuropsychopharmacology in January 2009, which is before the agency "cleared the device for use in depression" (actually treatment resistant depression) in 2014 and, for that matter, before NCT 00149838 was finished. The letter should clearly be associated with the earlier approval if included at all.

I suggest the following:
 * 1) If we are going to include the Adcom meeting we need to also mention the meta analysis stating that the trials are not in general unblinded, at least somewhere in the text if not in this section. Otherwise we are not giving people a clear picture of the overall evidence.
 * 2) I believe that the Public Citizen letter should be removed in its entirety.  Since when do we include in our articles speculation from activist groups criticizing reasoning that they hypothesize that a government regulatory agency might have employed? Just because someone said it doesn't mean it belongs in the article.
 * 3) If the PC letter remains (which I obviously oppose), let's at least associate it with the correct approval
 * 4) Lets get the approvals straight.  The earlier approval was for major depression and the latter for treatment resistant depression.

Thanks Formerly 98 (talk) 00:22, 17 November 2014 (UTC)


 * i didn't do anything with that section yet b/c i've been stewing on it. i don't think the current content is appropriate at all and i don't think going further down that road is useful....  what if we just report the facts simply, like "The FDA approved company X's product Z  for Y indication on DATE."   What do you think of that? Jytdog (talk) 00:34, 17 November 2014 (UTC)
 * Sounds good to me. Historically we've put a Medical Uses section in with efficacy data. We can pop FDA approval dates and foreign approvals (I don't know much about how that works, maybe IMS does)  in that section perhaps.  But right now it seems like the regulatory story is being used to make non-MEDRS insinuations about efficacy. Formerly 98 (talk) 01:08, 17 November 2014 (UTC)
 * regulatory would down at the bottom per WP:MEDMOS. Devices are approved just like drugs are.  If we find foreign approvals in reliable sources they would go there too. i'll make this change. Jytdog (talk) 01:45, 17 November 2014 (UTC)
 * by the way, if you make a tweak to a device you have to submit a new 510K and you will find many many 510Ks in series for most medical devices on the market. Or it you want to change the label even slightly.
 * The 2008 510K was for "the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current episode
 * The 2014 510K was for "the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode."
 * not a big deal. I don't think it is worth even mentioning the second one in an encyclopedia article. Jytdog (talk) 02:08, 17 November 2014 (UTC)

Regulatory approval should go in the society and culture section IMO. Doc James (talk · contribs · email) 01:33, 18 November 2014 (UTC)