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eNeura SpringTMS Post-Market Observational US Study of Migraine (ESPOUSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02357381
Recruitment Status : Completed
First Posted : February 6, 2015
Last Update Posted : June 18, 2021
Sponsor:
Information provided by (Responsible Party):
eNeura, Inc.

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.

Condition or disease Intervention/treatment
Headache Device: eNeura SpringTMS

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.

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Study Type : Observational
Actual Enrollment : 263 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: eNeura SpringTMS Post-Market Observational U.S. Study of Migraine
Actual Study Start Date : December 1, 2014
Actual Primary Completion Date : July 1, 2016
Actual Study Completion Date : July 1, 2016

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine

Group/Cohort Intervention/treatment
TMS Treatment
TMS( transcranial magnetic stimulation) -treatment for headache
Device: eNeura SpringTMS
Single pulse magnetic stimulation for prevention and/or treatment of migraine headache with or without aura.




Primary Outcome Measures :
  1. Headache Days [ Time Frame: 3 months ]
    Reduction in mean headache days



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02357381


Locations
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United States, Arizona
Mayo Clinic
Phoenix, Arizona, United States, 85054
United States, California
UCLA Headache Research and Treatment Program
Los Angeles, California, United States, 90095
Stanford Headache Program
Stanford, California, United States, 94563
United States, Maryland
Mid Atlantic Permanente Medical Group-Kaiser
Rockville, Maryland, United States, 20852
United States, New York
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
United States, Ohio
The Cleveland Clinic Center for Headache and Pain
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Jefferson Headache Center
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
eNeura, Inc.
Investigators
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Principal Investigator: David W Dodick, MD Mayo Clinic , Phoenix,AZ
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: eNeura, Inc.
ClinicalTrials.gov Identifier: NCT02357381    
Other Study ID Numbers: SpringTMSUSPMOS 2014-01
First Posted: February 6, 2015    Key Record Dates
Last Update Posted: June 18, 2021
Last Verified: April 2015
Additional relevant MeSH terms:
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Headache
Pain
Neurologic Manifestations