Trial ID or NCT#
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.
eNeura SpringTMS Post-Market Observational U.S. Study of Migraine
- 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.
- - 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.
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