Clinical trial NCT02357381: eNeura SpringTMS Post-Market Observational US Study of Migraine
Official title: eNeura SpringTMS Post-Market Observational U.S. Study of Migraine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Headache
Lead sponsor: eNeura, Inc.
Sponsor class: INDUSTRY
First posted: 2015-02-06
Enrollment: 263
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 4-25 headache days per month (confirmed by 1-month baseline diary, minimum of 5 complete headache-free days/month)

Brief summary: 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.

Detailed description: A prospective, non-randomized, single arm, multi-center observational study designed to evaluate the use of the SpringTMS system in reducing the frequency of headache days.

Note: This is a NON-SIGNIFICANT RISK (NSR) study of a NON-SIGNIFICANT RISK (NSR) Device. It is a post market study of a NSR device cleared by FDA through the 510(k) pre-market notification process. The cleared indications for use are provided above. This NSR study is designed to collect information on additional applications of the SpringTMS device. These additional applications include:

1. Use of the device to evaluate the potential for regular use of sTMS to reduce the frequency, severity, and/or duration of migraine.
2. Delivery of additional treatments (pulses) to evaluate the acute treatment efficacy of breakthrough migraine attacks with and without aura.

Eligibility criteria: 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.

Primary outcomes:
measure: Headache Days
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Los Angeles
country: United States
facility: UCLA Headache Research and Treatment Program
state: California
city: Stanford
country: United States
facility: Stanford Headache Program
state: California
city: Rockville
country: United States
facility: Mid Atlantic Permanente Medical Group-Kaiser
state: Maryland
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
city: Cleveland
country: United States
facility: The Cleveland Clinic Center for Headache and Pain
state: Ohio
city: Philadelphia
country: United States
facility: Jefferson Headache Center
state: Pennsylvania
Study officials:
affiliation: Mayo Clinic , Phoenix,AZ
name: David W Dodick, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Starling AJ, Tepper SJ, Marmura MJ, Shamim EA, Robbins MS, Hindiyeh N, Charles AC, Goadsby PJ, Lipton RB, Silberstein SD, Gelfand AA, Chiacchierini RP, Dodick DW. A multicenter, prospective, single arm, open label, observational study of sTMS for migraine prevention (ESPOUSE Study). Cephalalgia. 2018 May;38(6):1038-1048. doi: 10.1177/0333102418762525. Epub 2018 Mar 4.