Evaluating Cefaly

Recently, on the CBC television program, The Dragon’s Den (Episode 3, available here), a product that the sales team for Roxon claimed to prevent and treat migraine and tension headaches was demonstrated. The product, Cefaly, is a tiara-like headband worn over the forehead  delivers small electrical impulses. Their demonstration satisfied the Dragons, as they received $100,000 in return for 5% royalties.

The question is: does it work? The answer, it appears, is maybe, but not perhaps the way the marketing campaign claims.

First of all, anyone who has ever suffered from chronic headaches knows they can be totally debilitating for the duration of the pain and sometimes longer. The sufferer often remains in bed in the dark and quiet for hours and sometime days. There can be major negative impacts on work, relationships, and quality of life for the 300 million migraine sufferers.

Secondly, it is critical to have your pain evaluated by a MD to rule out such causes as brain tumours, hypertension, diabetes, or other diseases that may be life threatening.

Over the years, a lot of research money has been spent determine the causes of, and most effective treatments for Chronic Daily Headaches. Treatments range from lifestyle changes (diet, exercise, etc), to drugs and surgically implanted electrodes. None of these work 100% of the time in 100% of patients.

Since medical science has not developed a 100% effective cure, and pain is something that most often waxes and wanes over time, it is ripe for alternative practitioners to jump in with exaggerated or fabricated claims. It is important for sufferers and physicians to evaluate effective versus frivolous treatments.

So on to Cefaly.

The company is very careful not to make any definitive medical claims beyond pain relief.

Now available in Canada, Cefaly is a drug-free method for treating migraine pain and preventing migraine headaches from ever coming on.

Much of their advertising is based around their certifications.

Cefaly is a CE and ISO certified medical device designed to treat and prevent migraine headaches. Cefaly can considerably reduce or replace the consumption of side effect producing medications. Cefaly is the first cranial analgesic electrotherapeutic device to acquire ISO medical certification proven effective on migraine pain with no side effects.

Sounds very good. However, neither of these certifications has anything to say about effectiveness. CE or “Conformité Européene”, is primarily about consumer safety.

  1. CE Marking on a product is a manufacturer’s declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation, in practice by many of the so-called Product Directives.
  2. CE Marking on a product indicates to governmental officials that the product may be legally placed on the market in their country.
  3. CE Marking on a product ensures the free movement of the product within the EFTA & European Union (EU) single market (total 28 countries), and
  4. CE Marking on a product permits the withdrawal of the non-conforming products by customs and enforcement/vigilance authorities.

ISO is entirely a system of quality control and documentation.

Certainly you can be assured that the product is built to high standards, and devices that do not deliver the specified charges will not be on the market.

How comfortable can you be that the product will actually reduce or remove your pain? They have a page of medical references that I have evaluated below. Their website bases their treatment modality on two somewhat related concepts. Transcutaneous Electrical Nerve Stimulation (TENS), something that many of us who have been for physiotherapy are familiar with, and electro-acupuncture.

I will not comment on acupuncture, electro or other, in this article, as that would no doubt side-track any discussion. If you want more information, you can learn from the experts at Science Based Medicine.

Although TENS has been widely used for many years, the value of the practice in long term pain relief is far from settled. There are numerous studies that support TENS and some that are less than enthusiastic. For example, in a review published by Cochrane in 2008, concludes:

Published literature on the subject lacks the methodological rigour or robust reporting needed to make confident assessments of the role of TENS in chronic pain management.

A somewhat older review from 1998, published in the journal Health Technology Assessment reports:

Transcutaneous electrical nerve stimulation (TENS) has been shown not to be effective in postoperative and labour pain. In chronic pain, there is evidence that TENS effectiveness increases slowly, and that large doses need to be used. There is lack of evidence for the effectiveness of TENS in chronic pain.

One of the papers referenced on the Cefaly website Headache. 1989 Mar;29(3):156-62The effectiveness of physical therapy in the treatment of chronic daily headaches. Jay GW, Brunson J, Branson SJ. suggests that the effectiveness of treatments may be related to the sense of active intervention on the part of a practitioner. This can be considered to be one of the primary reasons many ‘alternative’ treatments seem to be effective.

On their website, Cefaly refers to a number of studies that specifically evaluate their product.

  • 12 laboratory studies to determine the choice of the most effective and precise parameters
  • 8 case report studies to confirm the effectiveness on patients regarded as ‘difficult cases’
  • 3 pilot studies on series of patients suffering from tension headaches or migraines
  • 2 blind studies to confirm the extent of the effectiveness

In total, more than 5,000 treatments were included in the studies to validate Cefaly’s clinical effectiveness.

However, searches in both Medline and PubMed did not yield any results referencing Cefaly by name. Without exact references, it is impossible to verify these studies. If anyone can find these, we could evaluate them in the discussion.

So is Cefaly an effective treatment for migraine headaches? Maybe, but any effect is probably due to the placebo effect. In other words, doing something can be better than doing nothing. It it worth the $300 purchase price? Only you can decide. I have merely attempted to bring a little bit of balance to their marketing claims.

Here is one of Cefaly’s marketing ads.

 

Below I have attempted to examine the studies that are listed on their site. In the left-hand column is their list hyperlinked. In the right-hand column are my comments, some quotes from the papers and some hyperlinks for further reading. In most cases I only had access to abstracts and the entire papers would assuredly have more details on study design and evaluation.

Very few, if indeed any, can be directly tied to the claims made by the company. This raises the question—why include the list other than to give the marketing claims the pretence of scientific validity?

From Cefaly page Comment
Curr Pain Headache Rep. 2008 Jan;12(1):62-6. Review Occipital nerve stimulation for medically intractable headache Schwedt TJ. Review Article focus on Occipital Nerve Stimulation (ONS) which involves implantation of electrodes in the brain.
Pain Physician. 2008 Mar-Apr;11(2):253-6. Percutaneous occipital stimulator lead tip erosion: report of 2 cases. Trentman TL, Dodick DW, Zimmerman RS, Birch BD. ONS case studies
J Clin Psychiatry. 2008 Mar;69(3):412-7. A pilot study of cranial electrotherapy stimulation for generalized anxiety disorder. Bystritsky A, Kerwin L, Feusner J. Preliminary study of CES for anxiety. CES is considered an ‘alternative’ treatment for many disorders. One product that uses this technology is Alpha Stim
Cephalalgia. 2008 Apr;28(4):355-9. Epub 2008 Feb 14.Peripheral nerve stimulator for the treatment of supraorbital neuralgia: a retrospective case series.Amin S, Buvanendran A, Park KS, Kroin JS, Moric M. Peripheral nerve stimulation involves the insertion of electrodes along nerve tracts of the peripheral nervous system.
Pain Pract. 2008 Mar-Apr;8(2):120-4. Epub 2008 Jan 7.Peripheral neurostimulation in supraorbital neuralgia refractory to conventional therapy.Asensio-Samper JM, Villanueva VL, Pérez AV, López MD, Monsalve V, Moliner S, De Andrés J. PNS
Acta Neurochir Suppl. 2007;97(Pt 1):115-20.Peripheral nerve stimulation for the treatment of neuropathic craniofacial pain.Slavin KV. PNS
Headache. 2007 Jul-Aug;47(7):1100-2.Supraorbital nerve electric stimulation for the treatment of intractable chronic cluster headache: a case report.Narouze SN, Kapural L. No details of technique, although it is most likely electrode implantation.
Expert Rev Neurother. 2007 Dec;7(12):1785-9.Neurostimulation in primary headache syndromes.Goadsby PJ. Invasive electrodes
Epilepsia. 2006 Jul;47(7):1213-5.Pilot study of trigeminal nerve stimulation (TNS) for epilepsy: a proof-of-concept trial.DeGiorgio CM, Shewmon A, Murray D, Whitehurst T.
External electrical stimulation, technique developed by author. More information here, here, and here.
Neurosurgery. 2006 Jan;58(1):112-9; discussion 112-9. Peripheral neurostimulation for treatment of intractable occipital neuralgia. Slavin KV, Nersesyan H, Wess C. PNS
Neurosurg Focus. 2006 Dec 15;21(6):E5Trigeminal and occipital peripheral nerve stimulation for craniofacial pain: a single-institution experience and review of the literatureSlavin KV, Colpan ME, Munawar N, Wess C, Nersesyan H. PNS
Neurosurgery. 2004 Jul;55(1):135-41; discussion 141-2.Peripheral stimulation for treatment of trigeminal postherpetic neuralgia and trigeminal posttraumatic neuropathic pain: a pilot study.Johnson MD, Burchiel KJ. PNS
Neurology. 2003 Aug 12;61(3):421-2.Trigeminal nerve stimulation for epilepsy.DeGiorgio CM, Shewmon DA, Whitehurst T. External electrical stimulation, technique developed by author. More information here, here, and here.
Arch Physiol Biochem. 2001 Oct;109(4):304-8.Electrical stimulation of the trigeminal tract in chronic, intractable facial neuralgia.Holsheimer J. PNS
Headache. 2007 Jul-Aug;47(7):1100-2.Supraorbital nerve electric stimulation for the treatment of intractable chronic cluster headache: a case report. Narouze SN, Kapural L. No information beyond title
Cochrane Database Syst Rev. 2004;(3):CD001878.Review: Non-invasive physical treatments for chronic/recurrent headache. Review of non-invasive chronic headache treatments. Nothing very conclusive.
Headache. 2004 Apr;44(4):333-41.Electroacupuncture for tension-type headache on distal acupoints only: a randomized, controlled, crossover trial. Xue CC, Dong L, Polus B, English RA, Zheng Z, Da Costa C, Li CG, Story DF. RMIT Chinese Medicine Research Group, RMIT University, Bundoora, Victoria, Australia.
Neurol Sci. 2003 May;24 Suppl 2:S138-42.Non-pharmacological approaches to chronic headaches: transcutaneous electrical nerve stimulation, lasertherapy and acupuncture in transformed migraine treatment. Allais G, De Lorenzo C, Quirico PE, Lupi G, Airola G TENS, lasertherapy and acupuncture, all participants received all three treatments. Conclusion was acupuncture was the most effective
Cochrane Database Syst Rev. 2001;(3):CD003222.Transcutaneous electrical nerve stimulation (TENS) for chronic pain. Carroll D, Moore RA, McQuay HJ, Fairman F, Tramèr M, Leijon G. CONCLUSIONS:

The results of this review are inconclusive; the published trials do not provide information on the stimulation parameters which are most likely to provide optimum pain relief, nor do they answer questions about long-term effectiveness.

Headache. 1999 Jul-Aug;39(7):502-5Use of percutaneous electrical nerve stimulation (PENS) for treating ECT-induced headaches. Ghoname EA, Craig WF, White PF. PENS is electro-acupuncture
Headache. 2000 Apr;40(4):311-5Use of percutaneous electrical nerve stimulation (PENS) in the short-term management of headache. Ahmed HE, White PF, Craig WF, Hamza MA, Ghoname ES, Gajraj NM. PENS is electro-acupuncture. Same authors as above
CMAJ. 1997 May 1;156(9):1273-87Guidelines for the diagnosis and management of migraine in clinical practice. Canadian Headache Society. Link to guidelines. Comment on TENS: On Tens and acupuncture: Patients who enquire about transcutaneous electrical stimulation and acupuncture should be made aware of the lack of firm evidence as to the benefits and cost- effectiveness of these treatments in the management of migraine
Ann Ital Chir. 1997 Jul-Aug;68(4):505-9The treatment of cranio-facial pain by electroacupuncture and laser irradiation. Costantini D, Delogu G, Lo Bosco L, Tomasello C, Sarra M All patients received the treatments of electro-acupuncture and laser irradiation. No controls
J Tradit Chin Med. 1995 Jun;15(2):124-6 202Cases of headache treated with electroacupuncture. Zhang L, Li L. No details beyond title
Ann Acad Med Singapore. 1995 Jan;24(1):17-22The use of transcutaneous electrical nerve stimulation (TENS) in the treatment of facial pain. Holt CR, Finney JW, Wall CL. Assumes effectiveness of TENS for facial pain, and proposes using a response to TENS as a diagnostic tool
Headache. 1989 Jul;29(7):445-50Safety and effectiveness of cranial electrotherapy in the treatment of tension headache. Solomon S, Elkind A, Freitag F, Gallagher RM, Moore K, Swerdlow B, Malkin S.. CES as above External electrical stimulation, technique developed by author. More information here, here, and here.
Headache. 1989 Mar;29(3):156-62The effectiveness of physical therapy in the treatment of chronic daily headaches. Jay GW, Brunson J, Branson SJ. Suggest TENS is useful for chronic daily headaches, but also comment that improvement may be due to patient interactions.
Headache. 1989 Jan;29(1):34-41Non-invasive treatment of vascular and muscle contraction headache: a comparative longitudinal clinical study. Reich BA. Repeated measure analysis of variance indicated that grouping variables of Biofeedback treatment, symptoms being evidenced less than 2 years and receiving over 15 treatment sessions best predicted successful intervention.
Psychiatr Neurol Med Psychol (Leipz). 1988 Dec;40(12):717-23Punctate transcutaneous electrical nerve stimulation in migraine therapy Heydenreich A. Electro-acupuncture
Headache. 1986 Sep;26(8):431-3Headache and cervical spine disorders: classification and treatment with transcutaneous electrical nerve stimulation. Farina S, Granella F, Malferrari G, Manzoni GC. No details beyond title
Headache. 1985 Jan;25(1):12-5Treatment of headache by transcutaneous electrical stimulation. Solomon S, Guglielmo KM. No details beyond title
Phys Ther. 1984 Sep;64(9):1367-74 Effect of transcutaneous electrical nerve stimulation on human blood beta-endorphin levels. O’Brien WJ, Rutan FM, Sanborn C, Omer GE. We could find no evidence that TENS altered experimental pain threshold or plasma beta-endorphin levels.
Res Clin Stud Headache 2: 29-59 (1969)
The possible relationship of serotonin to the migraine syndrome.
Anthony, M, Hinterberger, H, Lance, JW
Unable to find article on-line
Cephalalgia 15 : 277-280 (1995)Neurogenic model of migraine.Buzzi, MG, Bonamini, M, Moskowitz, MA Based upon animal models: The experimental model of electrical trigeminal ganglion stimulation or systemic capsaicin administration has proven effective in detecting cellular activation in brainstem trigeminal nuclei
Pain 19: 259-275 (1984a)Prolongated inhibition of primate spinothalamic tract cells by peripheral nerve stimulation..Chung, JM, Fang, ZR, Hori, Y, Lee, KH, Willis, WD Direct stimulation of nerves in decerebrate and spinalized animals as well as in intact anesthetized monkeys.
Pain 19: 277-293. (1984b)Factors influencing peripheral nerve stimulation produced inhibition of primate spinothalamic tract cells.Chung, JM, Lee, KH, Hori, Y, Endo, K, Willis, WD As above: Direct stimulation of nerves in decerebrate and spinalized animals as well as in intact anesthetized monkeys.
Cephalalgia 13 : 151-165 (1993)On serotonin and migraine: a clinical and pharmacological review..Ferrari, MD, Saxena, PR Proposes a link between serotonin and the trigeminal nerve rand migraines. No suggestion as to treatments or other details.
Médecine-Sciences 9 : 21-30 (1993) Les récepteurs centraux de la sérotonine. Hamon, M, Gozlan, H Article is in French. Bing english translation: Serotonin (5-hydroxytryptamine, 5-HT) is a neurotransmitter involved in the control of many brain functions: cycles/sleep, thermoregulation, behaviour of hunger/satiety, sexual behaviour, nociception, etc. In addition, neuropsychiatric disorders such as depression, dementia and anxiety are associated with functional abnormalities of serotonergic neurons. This diversity of functions of the 5-HT is most likely related to the multiplicity of its receptors (at least ten), some of them being coupled with several effector systems.
Physical Therapy 58 : 1467-1473 (1978)
Peripheral neural excitability. Implications for transcutaneous electrical nerve stimulation.
Howson, D
Unable to find article on-line
Journal of Neurosurgery 45 : 159-165 (1976)Direct effect of electrical stimulation on peripheral nerve evoked activity : implications in pain relief..Ignelzi, RJ, Nyquist, JK, Experiments were performed with a peripheral neurostimulator, used clinically for pain relief, on isolated cat cutaneous peripheral nerve to determine the effect of electrical stimulation on components of the compound action potential. The results show that neurostimulation alters the conduction velocity and the amplitude of both the A-alpha and beta and the A-delta waves with the more slowly-conducting A-delta component showing the greatest changes. This direct alteration of peripheral nerve activity distal to the first synapse in the spinal cord might contribute to the mechanism of pain relief.
Physical Therapy 74: 951-962 (1994)The effects of selected stimulus waveforms on pulse and phase characteris-tics at sensory and motor thresholds. Kantor, G, Alon, G, Ho, H Examined TENS on arm and leg to determine motor and sensory nerve excitation thresholds.
Brain 117 : 199-210 (1994)Pathophysiology of the migraine aura. The spreading depression theory.Lauritzen, M Wikipedia: Cortical spreading depression is a wave of electrophysiological hyperactivity followed by a wave of inhibition, usually in the visual cortex.
Science 150: 971-979 (1965)Pain mechanisms: A new theory.Melzack, R, Wall, P Gate control system modulates sensory input from skin before it evokes pain perception and response
Electroencephalography and Clinical Neu-rophysiology. 74 : 24-35 (1989)Influences of transcutaneous electrical stimulation of cutaneous and mixed nerves on subcortical and cortical somatosensory evoked potentials.Nardone, A, Schieppati, M, TENS evoked response in both peripheral and central neurons.
Ann Med Interne 143 : 173-183 (1992)
Physiopathogénie de la migraine.
Ollat, H, Bousser, MG
Unable to find article on-line
Science 164: 444-445. (1969)Surgery in the rat during electrical analgesia induced by focal brain stimulation.Reynolds, DV Analgesia in rats by using implanted electrodes and direct stimulation
Science 155: 108-109. (1967)Temporary abolition of pain in man.Wall, PD, Sweet, WH TENS on 8 patients with peripheral nerve disorders received rellief from pain during stimulation. Relief continued for 1/2 hour in 4 patients after 2 minute stimulation.

7 Responses to “Evaluating Cefaly”

  1. Paul says:

    Excellent post! I too watch Dragon’s Den and was skeptical when I saw the product. Google searches didn’t reveal much however. I made a post over on reddit and you’ve definitely addressed a lot of the questions raised. – http://www.reddit.com/r/skeptic/comments/kyu6k/cefaly_a_300_medical_device_that_claims_to_be/

    I do have access to a bunch of scientific journals (as I am a student) so I will download what articles I can find and post them in full later today so that you have more than the abstract to go on.

  2. pierre says:

    Hi John and Paul, I have new information about Cefaly I’d like to provide you. Can you let me know your email address?
    Thank in advance, Pierre.

    • I received this email yesterday from the CEO of STX Med, the makers of the Cefaly device.
      Doctor Pierre RIGAUX
      STX-Med
      ZI des Hauts Sarts
      4ème Avenue N°5
      B-4040, Herstal, Blegium
      http://www.stx-med.com

      Scientific data on the Cefaly website are obsolete and have to be update but actually there is a lag between clinical tests outcomes and publication in peer-review where there are making available for the public. I guess that within 6 months that should be all solved.

      Neurostimulation or neuromodulation for the treatment of headaches is in use with implantable neurostimulators (see here under a list of references). It is mainly applied on the occipital nerve for technical reasons: easy to place an implantable electrode in the occipital region but not on the forehead. Nevertheless physiologically, as the trigeminal nerve is concerned, it makes more sense to apply the neurostimulation on the trigeminal nerve.

      Therefore theem> challenge was to develop a technique of trigeminal nerve stimulation but externally in order to be safe, easy and not expensive contrary to implantable neurostimulators (Medtronic, Boston technology, St Jude). So, external trigeminal nerve stimulation TNS (what cefaly is doing) has been developed and investigated. Pilot tests where conducted about the changes in trigeminal nociceptive threshold and migraine attacks prevention. But neurologists consider that TNS should have basically a sedative effect on the central nervous system which can be used to prevent migraine and epilepsy.

      The evidence of the sedative effect has been demonstrated by a double blinded cross-over sham-controlled trial on 30 subjects using the cefaly device. It has been accepted for publication by BMC Neurology and should be available soon, likely in the very next weeks. The title is:

      Supraorbital transcutaneous neurostimulation has sedative effects in healthy subjects

      Maxime Piquet1, Costantino Balestra1, Simona L Sava2, Jean E Schoenen2

      1 Environmental, Occupational and Ageing Physiology Laboratory, DAN Europe

      Research, Haute Ecole Paul Henri Spaak, I.S.E.K., Brussels, Belgium

      2 Headache Research Unit. Department of Neurology & GIGA – Neurosciences.

      Liège UniversitThe third is to another on surgical implantationy, CHU-Sart Tilman. T4 (+1). B36., B-4000 LIEGE. Belgium.

      I cannot provide you the article or abstract before it is released by BMC Neurology. But I’ll send it to you as soon it is available.

      Based on this sedative effect on the central nervous system 2 ways of investigation have been conducted: for epilepsy prevention and for migraine prevention.

      For epilepsy prevention here attached are the available publications but the main one, a phase II randomized double blinded sham-controlled trial, is not published yet. It should be published in the next months and the press release of the press conference is here attached to give you an idea of the outcomes.

      Matharu MS, Bartsch T, Ward N, Frackowiak RS, Weiner R, Goadsby PJ. Central neuromodulation in chronic migraine patients with suboccipital stimulators: a PET study. Brain. 2004;127:220-30.
      Magis D., Allena M., Bolla M., De Pasqua V., Remacle J-M. and Schoenen J. Occipital nerve stimulation for drug-resistant chronic cluster headache: a a prospective pilot study. Lancet Neurology 2007, 6, 314-321
      Joel R Saper, David W Dodick, Stephen D Silberstein, Sally McCarville, Mark Sun and Peter J Goadsby. Occipital nerve stimulation for the treatment of intractable chronic migraine headache: ONSTIM feasibility study. Cephalalgia 2010 ; 31(3) 271–285
      Reed KL, Black SB, Banta CJ 2nd, Will KR. Combined occipital and supraorbital neurostimulation for the treatment of chronic migraine headaches: initial experience. Cephalalgia. 2010 Mar;30(3):260-71. Epub 2010 Feb 15.

      The first, third and fourth references are to papers on the surgical implantation of electrodes
      The second is to the slide show of a talk on CDH and does not mention TENS

      I would also like to address to Dr. Rigaux directly that I find it disingenuous to state

      Scientific data on the Cefaly website are obsolete and have to be update but actually there is a lag between clinical tests outcomes and publication in peer-review where there are making available for the public

      As I indicated in the original post, very few of the references support the claims made by for Cefaly.

      Dr. Rigaux also sent me, as email attachments, 3 papers and a press release.
      TRIGEMINAL NERVE STIMULATION FOR EPILEPSY: LONG-TERM FEASIBILITY AND EFFICACY Christopher M. DeGiorgio, MD, Diana Murray, Daniela Markovic, MS and Todd Whitehurst, MD This study was involved a small number of patients Thirteen subjects completed the 4-week prospective baseline. Twelve completed 3 months, 10 completed 6 months, and 7 completed 12 months , and one of the authors, DeGiorgio, has been involved in the development of an TENS instrument. This does not mean the study is not valid, but it does require replication before the technique should be accepted.
      Pilot Study of Trigeminal Nerve Stimulation (TNS) for Epilepsy: A Proof-of-Concept Trial, Christopher M. DeGiorgio, Alan Shewmon,Diane Murray, and Todd Whitehurst is another study authored by DeGiorgio. The results showed improvement in 4 out of 7 patients. A good proof of concept, but that’s all.
      Trigeminal nerve stimulation in major depressive disorder: First proof of concept in an open pilot trial Lara M. Schrader, Ian A. Cook ⁎, Patrick R. Miller, Eve R. Maremont, Christopher M. DeGiorgio (In Press). Dr Rigaux kindly provided me with a copy of the paper. This is another proof of concept study involving 5 patients.

      The press release is from C. DeGiorgio. The results state:

      The investigators reported that patients receiving active eTNS™ treatment experienced a significant improvement in seizure reduction, while those randomized to receive the control condition (“sham” or “placebo”) did not.  ”We showed that eTNS™ works well, under stringent clinical-trial conditions, with nearly 40% showing a clinically-meaningful response after 18 weeks of daily stimulation – there were 9 responders in the active group in contrast to 3 in the control group, where a responder experiences a greater than 50% reduction in seizures,” noted Dr. DeGiorgio. In addition to reducing seizures, eTNS™ also improved mood.  These results confirm and extend the findings of DeGiorgio’s positive feasibility trial in epilepsy, reported in 2009 in the prestigious journal Neurology.
      CAUTION: Both eTNS™ and sTNS™ systems are investigational devices and at this time are limited by United States law for investigational use only

      (emphasis mine-JU)

      Three studies, one each on depression, epilepsy, and migraine are all promising do not add up to ‘proof’. This device may prove to be the future of treatment for these disorders, but it seems to me to be premature to expect too much.

  3. Paul says:

    Sorry for the delay but my God did that take a long time. Most of the journal articles are in a zip folder in the link below. The ones that aren’t are either reviewed thoroughly by John, free, I couldn’t find, or too hard to find.

    http://www.uploadstation.com/file/S4zVh9C/cefaly.zip

  4. Paul says:

    If you’re having trouble with the captcha you may want to try megaupload instead. This link has the additional article I originally forgot to include in the zip file.

    http://www.megaupload.com/?d=3S2WOOFK

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  • John Underhay

    John Underhay, also known as Peicurmudgeon, is just your average atheist, left leaning, SCUBA diving, snorkeling, biker. He lives on PEI and spends some of his time attempting to point out the flaws and or dangers in promoting ideas that run contrary to the laws of physics, chemistry, or biology. He has a BSc (Biology) and an MSc (Pharmacology) from the University of Prince Edward Island, and is currently retired. You can read more of his posts at http://peicurmudgeon.wordpress.com/