eneura springtms post-market observational us study of migraine

Conditions: Headache

Summary: a multi-center, prospective, non-randomized, single arm, open label, post-market, observational study to evaluate the use of the eneura, springtms system in reduction of migraine headache symptoms.

a prospective, non-randomized, single arm, multi-center observational study designed to evaluate the use of the springtms system in reducing the frequency of headache days. note: this is a non-significant risk (nsr) study of a non-significant risk (nsr) device. it is a post market study of a nsr device cleared by fda through the 510(k) pre-market notification process. the cleared indications for use are provided above. this nsr study is designed to collect information on additional applications of the springtms device. these additional applications include: 1. use of the device to evaluate the potential for regular use of stms to reduce the frequency, severity, and/or duration of migraine. 2. delivery of additional treatments (pulses) to evaluate the acute treatment efficacy of breakthrough migraine attacks with and without aura.

Eligibility criteria:
inclusion criteria: 1. patients 18 to 65 years of age; 2. patients able to understand and communicate in english; 3. migraine with or without aura; 4. 4-25 headache days per month (confirmed by 1-month baseline diary, minimum of 5 complete headache-free days/month); 5. understand and willing to provide diary and survey data. exclusion criteria: * subjects will be excluded from participating in this trial if they meet any of the following criteria 1. severe co-existing disease having a life expectancy of less than 1 year; 2. currently involved in any other investigational clinical trials that have not completed their primary endpoint or that may interfere with the springtms study results; 3. mental impairment or other conditions which may not allow the subject to understand the nature, significance and scope of the study and to cooperate with follow-up requirements; 4. known drug and/or alcohol addiction or use of illicit substances; 5. patients with epilepsy or history of seizure; 6. severe active major depression or major psychiatric illness; 7. concurrent use of other neurostimulation devices (cefaly®, tens, implantable devices); 8. use of botox® within past 4 months; 9. extracranial nerve block (e.g. occipital, supraorbital) within past 3 months; 10. use of cefaly for prevention within past month; 11. patients with metal containing implants as follows: the springtms may not be used in patients who have metals, conductive materials, or metal-containing implants in their head, neck or upper body. patients with implants that are affected by a magnetic field should not use the springtms. examples of such implants include: * aneurysm clips or coils • radioactive seeds * cochlear implants • magnetically programmable shunt valves * cerebral spinal fluid shunts • stents * bullets or pellets lodged in the head or upper body • metal plates, screws, staples or sutures in skull, neck, shoulders, arms or hands * filters • metallic artificial heart valves * electrodes • facial tattoos with metallic ink dental implants, fillings, or other dental appliances are okay and are not affected by the device. note: although not explicitly excluded, safety and effectiveness have not been established in pregnant women. please defer to the judgment of the investigator when considering the eligibility of this population.