eNeura SpringTMS Post-Market Observational US Study of Migraine

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:

• Use of the device to evaluate the potential for regular use of sTMS to reduce the frequency, severity, and/or duration of migraine.
• Delivery of additional treatments (pulses) to evaluate the acute treatment efficacy of breakthrough migraine attacks with and without aura.

Inclusion criteria

• Patients 18 to 65 years of age;
• Patients able to understand and communicate in English;
• Migraine with or without aura;
• 4-25 headache days per month (confirmed by 1-month baseline diary, minimum of 5 complete headache-free days/month);
• 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

• Severe co-existing disease having a life expectancy of less than 1 year;
• Currently involved in any other investigational clinical trials that have not completed their primary endpoint or that may interfere with the SpringTMS study results;
• 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;
• Known drug and/or alcohol addiction or use of illicit substances;
• Patients with epilepsy or history of seizure;
• Severe active major depression or major psychiatric illness;
• Concurrent use of other neurostimulation devices (Cefaly®, TENS, implantable devices);
• Use of Botox® within past 4 months;
• Extracranial nerve block (e.g. occipital, supraorbital) within past 3 months;
• Use of Cefaly for prevention within past month;
• 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.