Clinical Data & Publications

Clinical Trials and Studies

A Multicenter, Prospective, Single Arm, Open Label, Post-Market, Observational Study to evaluate the use of sTMS in reduction of Migraine Headache (ESPOUSE Study) Starling AJ, Tepper SJ, Marmura MJ, Shamim EA, Robbins MS, Hindiya N, Charles AC, Goadsby PJ, Lipton RB, Silberstein SD, Gelfand AA, Chiacchierini RP and Dodick DW. Cephalalgia. 2018. 0(0) I-II. DOI: 10.1177/0333102418762525.

Abstract: The objective of this clinical trial was to evaluate the efficacy and tolerability of sTMS for the preventive treatment of migraine. The primary effectiveness endpoint, mean reduction of headache days, was met and was statistically significant. Secondary effectiveness endpoints were all met: reduction in acute medication days, reduction in HIT-6 score and a reduction in total headache days of any pain intensity. sTMS was well tolerated. Based on the ESPOUSE study and a previous UK Study, the FDA cleared sTMS for the prophylactic treatment of migraine headache. View Full Text

Transcranial Magnetic Stimulation for Migraine Prevention in Adolescents: A Pilot Open-Label Study Irwin SL, Qubty W, Allen E, Patniyot I, Goadsby PJ, Gelfand AA. Headache 2018. doi: 10.1111/head.13284

Summary: To assess the feasibility, tolerability, and patient acceptability of single-pulse transcranial magnetic stimulation (sTMS) for migraine prevention in adolescents in an open-label pilot study. View Full Text

Single-pulse transcranial magnetic stimulation for acute treatment of migraine with aura: a randomised, double-blind, parallel-group, sham-controlled trial. Lipton RB, Dodick DW, Silberstein SD, et al.The Lancet Neurology. 2010;9(4):373-380.\r\ndoi:

Summary: The efficacy and safety of a new portable sTMS device for acute treatment of migraine with aura were assessed in a randomized, double-blind, parallel-group, 2-phase, sham-controlled study at 18 centers in the USA. Early treatment resulted in increases freedom from pain at 2 hours and absence of pain at 24 and 48 hours after treatment. View Full Text

Real World Evidence (RWE)

Single-pulse transcranial magnetic stimulation for the preventive treatment of difficult-to-treat migraine: a 12-month prospective analysis JO Lloyd, B Hill, M Murphy, A Al-Kaisy, AP Andreou, G Lambru. J Headache Pain 2022;23-63. Doi:10.1186/s10194-022-01428-6.

Summary: This open label analysis suggest that sTMS may be an effective, well-tolerated treatment option for the long-term prevention of difficult-to-treat Cm and HFEM. View Full Text

Single-pulse Transcranial Magnetic Stimulation (sTMS) for the Treatment of Migraine: A Prospective Real World Experience Lambru G, Hill B, Lloyd J, Al-Kaisy A, Andreou AP. Cephalalgia. 2018, Vol 38 (I S) 150.

The Headache Centre, Guy’s and St. Thomas’ NHS Foundation Trust London UK

Conclusion: sTMS may constitute an effective and well tolerated preventive treatment option for difficult-to-treat high frequency/chronic migraine patients in a real world NHS setting. Since sTMS is less costly than Botox on the NHS, it could be included as one of the three preventive treatment to offer to chronic migraine patients prior to Botox. View Full Text

Single-pulse transcranial magnetic stimulation (sTMS) for the acute treatment of migraine: evaluation of outcome data for the UK post market pilot program Bhola R, Kinsella E, Giffin N, et al.J Headache Pain. 2015;16:535. doi:10.1186/s10194-015-0535-3.

Abstract: Migraine patients with and without aura were treated with sTMS over 12 weeks and reported significant pain relief along with a reduction in monthly headache days, demonstrating that sTMS may be a valuable addition to options for the treatment of both episodic and chronic migraine. View Full Text

Use of single pulse TMS (sTMS) to treat migraine with medication overuse Bhola R, Kinsella E, Weatherby S, et al. Abstract, IHC 17th Congress of the International Headache Society; May 14–17, 2015; Valencia, Spain

Summary:In this study, neurologists advised reduction of triptan and OTC medications in tandem with regular sTMS therapy over a period of 3 months for selected migraine patients. Analyzing their results, they conclude that sTMS may be an effective bridge treatment for migraine patients with medication overuse. View Full Text


Association Between MRI Exposure During Pregnancy and Fetal and Childhood Outcomes Joel G. Ray,MD, MSc, FRCPC; Marian J. Vermeulen, BScN, MHSc; Aditya Bharatha, MD, FRCPC; Walter J. Montanera, MD, FRCPC; Alison L. Park, MSc JAMA. 2016;316(9):952-961. doi:10.1001/jama.2016.12126

Summary: Exposure to MRI during the first trimester of pregnancy compared with nonexposure was not associated with increased risk of harm to the fetus or in early childhood. Note: There are no contraindications for use of SAVI Dual in patients who are pregnant or breastfeeding. Consult your healthcare professional to see if SAVI Dual is a good treatment option for you. View Full Text

Single pulse transcranial magnetic stimulation (sTMS) as a non-drug treatment option for pregnant patients with migraine. Bhola R, Giffin N, Ahmed F. Abstract, 2013 International Headache Congress; June 27–30, 2013; Boston, MA. View full text

Transcranial magnetic stimulation for migraine: a safety review. Dodick DW, Schembri CT, Helmuth M, Aurora SK.Headache. 2010;50(7):1153-1163. doi:10.1111/j.1526-4610.2010.01697.x/abstract.

Summary: In an analysis of studies of single-pulse and repetitive TMS, potential and theoretical safety concerns of transcranial (TMS) are reviewed. Safety concerns associated with sTMS in the context of its use as a migraine treatment are specifically considered. It is concluded that the safety of sTMS in clinical practice is supported by biological, empirical, and clinical trial evidence and that it may offer a safe therapeutic alternative to the currently prescribed drugs for patients who suffer from migraine. Link to journal

Mechanism of Action

sTMS Blocks Cortical Spreading Depression by Suppressing Cortical Neuronal Firing and by Increasing the Threshold of Activation of the Occipital Cortex Lloyd DO, Okine BN, Jones MF, Al-Kaisy A, Lambru G, McMahon SB, Andreou AP. Abstract: 18th Congress of the International Headache Society, September 7-11, 2017; Vancouver, BC Canada.

Abstract: This study aimed to investigate the cortical actions of sTMS in a migraine model. The data show that sTMS, when applied at intensities below the motor activation threshold suppresses spontaneous and glutamate-induced neuronal activity at the visual cortex and increases the electrical threshold required for a CSD induction. Collectively, these findings suggest that sTMS reduces cortical excitability by increasing the threshold of activation or cortical neurons. View Full Text

Transcranial Magnetic Stimulation: Basic Principles and Clinical Applications in Migraine 2017 Mar;57(3):517-524. doi: 10.1111/head.13002. Epub 2016 Dec 28.

Discussion: Migraine is a debilitating condition characterized by headache, nausea, and sensory hypersensitivity. It may affect up to 15% of the population, yet current drug treatments are often poorly tolerated. Clinical studies have shown that TMS is an effective treatment for migraine. In addition, it has the added advantages of being safe and well tolerated by patients. View Full Text

Transcranial magnetic stimulation and potential cortical and trigeminothalamic mechanisms in migraine. Andreou AP, Holland PR, Akerman S, Summ O, Fredrick J, Goadsby PJ. Brain. 2016;139(7):2002-2014. doi:10.1093/brain/aww118.

Abstract: The potential mechanisms of action of transcranial magnetic stimulation were investigated, using a trans-cortical approach, in preclinical migraine models. It was demonstrated that cortical spreading depression can be blocked in vivo using single pulse transcranial magnetic stimulation and may have a novel thalamocortical modulatory capacity that may explain the efficacy of magnetic stimulation in the treatment of migraine with and without aura. View Full Text

Professional Guidelines

The American Headache Society Consensus Statement: Update on integrating new migraine treatments into clinical practice. Ailani J, Burch RC, Robbins MS; Board of Directors of the American Headache Society. Headache. 2021 Jul;61(7):1021-1039. doi: 10.1111/head. View Full Text

Neuromodulation for the Acute and Preventive Therapy of Migraine and Cluster Headache Halker Singh RB, Ailania J and Robbins MS. Headache 2019 doi: 10.1111/head.13586

Summary: As there have been devices that have gained FDA clearance for migraine and cluster headache since previous review articles on neuromodulation have been published, our paper will focus on those key studies. We will also briefly review devices in development and also highlight the use of neuromodulation in certain groups who may otherwise have limited treatment options, including the elderly, children, and women who are pregnant. View Full Text

Economic Analysis

Cost impact of a non‑invasive, portable device for patient self‑administration of chronic migraine in a UK National Health Service setting B. Brüggenjürgen, T. Baker, R. Bhogal and F. Ahmed SpringerPlus (2016) 5:1249

Conclusion: The current risk share based remuneration model of TMS allows the UK NHS to reimburse only the cost of those patients experiencing reduction in migraine days resulting in lower costs for treating migraine attacks. Treatment of chronic refractory migraine using TMS implies a substantial cost reduction potential for the management of chronic treatment of refractory migraine patients compared to conventional Botox treatment. View Full Text