eNeura SpringTMS Post-Market Observational US Study of Migraine

Not Recruiting

Trial ID: NCT02357381

Purpose

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.

Official Title

eNeura SpringTMS Post-Market Observational U.S. Study of Migraine

Eligibility


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.

Intervention(s):

device: eNeura SpringTMS

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Evalina Salas
650-723-6469