eNeura SpringTMS Post-Market Observational US Study of Migraine

Completed

Conditions studied: Headache

In brief

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.

Key facts

Study ID

NCT02357381

Run by

eNeura, Inc.

People needed

263

Starts

2014-12-01

Expected to finish

2016-07-01

Last updated by the study team

2021-06-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients 18 to 65 years of age;
• Patients able to understand and communicate in English;
• Migraine with or without aura;
• 4-25 headache days per month (confirmed by 1-month baseline diary, minimum of 5 complete headache-free days/month);
• Understand and willing to provide diary and survey data.

You may not qualify if…

• Subjects will be excluded from participating in this trial if they meet any of the following criteria
• Severe co-existing disease having a life expectancy of less than 1 year;
• Currently involved in any other investigational clinical trials that have not completed their primary endpoint or that may interfere with the SpringTMS study results;
• 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;
• Known drug and/or alcohol addiction or use of illicit substances;
• Patients with epilepsy or history of seizure;
• Severe active major depression or major psychiatric illness;
• Concurrent use of other neurostimulation devices (Cefaly®, TENS, implantable devices);
• Use of Botox® within past 4 months;
• Extracranial nerve block (e.g. occipital, supraorbital) within past 3 months;
• Use of Cefaly for prevention within past month;
• 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.

Where it is running

• Mayo Clinic — Phoenix, Arizona, United States
• UCLA Headache Research and Treatment Program — Los Angeles, California, United States
• Stanford Headache Program — Stanford, California, United States
• Mid Atlantic Permanente Medical Group-Kaiser — Rockville, Maryland, United States
• Albert Einstein College of Medicine — The Bronx, New York, United States
• The Cleveland Clinic Center for Headache and Pain — Cleveland, Ohio, United States
• Jefferson Headache Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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