Trial Search Results

eNeura SpringTMS Post-Market Observational US Study of Migraine

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

eNeura, Inc.

Stanford Investigator(s):


  • Device: eNeura SpringTMS


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

      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

      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

   - 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.

Ages Eligible for Study

18 Years - 65 Years

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Evalina Salas
Not Recruiting