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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