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:

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.

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.