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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2015 by eNeura, Inc..
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
Daniel & Daniel Consulting LLC
Information provided by (Responsible Party):
eNeura, Inc.
ClinicalTrials.gov Identifier:
NCT02357381
First received: February 3, 2015
Last updated: October 9, 2015
Last verified: April 2015
  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.

Condition Intervention
Headache
Device: eNeura SpringTMS

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: eNeura SpringTMS Post-Market Observational U.S. Study of Migraine

Resource links provided by NLM:


Further study details as provided by eNeura, Inc.:

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


Estimated Enrollment: 250
Study Start Date: January 2015
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 65 Years   (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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02357381

Contacts
Contact: Cynthia Harris, BS 775-392-2970 cindy@clinregconsult.com
Contact: Michael Daniel, BS,MS,MBA 775-392-2970 cindy@clinregconsult.com

Locations
United States, Arizona
Mayo Clinic Recruiting
Phoenix, Arizona, United States, 85054
United States, California
UCLA Headache Research and Treatment Program Recruiting
Los Angeles, California, United States, 90095
Principal Investigator: Andrew Charles, MD         
Stanford Headache Program Recruiting
Stanford, California, United States, 94563
Contact: Evalina Salas    650-723-6469    evalinas@stanford.edu   
Principal Investigator: Nada Ahmad Hindiyeh, MD         
United States, Maryland
Mid Atlantic Permanente Medical Group-Kaiser Recruiting
Rockville, Maryland, United States, 20852
Contact: Aundria Cosby, RN,BSN,CCRP    301-816-6378    Aundria.C.Cosby@kp.org   
Principal Investigator: Ejaz Shamin, MD         
United States, New York
Albert Einstein College of Medicine Recruiting
Bronx, New York, United States, 10461
Contact: Eileen Summers       esummers@brany.com   
Contact: Khosrow Rezagholi       krezagho@montefiore.org   
Principal Investigator: Matthew Robbins, MD         
Mount Sinai St. Luke's and Mount Sinai Roosevelt Not yet recruiting
New York, New York, United States, 10025
Contact: Iris Harris       iharris@CHPNET.ORG   
Principal Investigator: Lawrence Newman, MD         
United States, Ohio
The Cleveland Clinic Center for Headache and Pain Recruiting
Cleveland, Ohio, United States, 44106
Contact: Michael Zeleny    216-636-5549    ZELENYM@ccf.org   
Principal Investigator: Stewart Tepper, MD         
United States, Pennsylvania
Jefferson Headache Center Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Kathleen Bradley, RN,BSN    215-955-2546    Kathleen.Bradley@jefferson.edu   
Contact: Rose Tausendfreundt    215-503-8542    Rose.Tausendfreundt@jefferson.edu   
Principal Investigator: Michael Marmura, MD         
Sponsors and Collaborators
eNeura, Inc.
Daniel & Daniel Consulting LLC
Investigators
Principal Investigator: David W Dodick, MD Mayo Clinic , Phoenix,AZ
  More Information

Responsible Party: eNeura, Inc.
ClinicalTrials.gov Identifier: NCT02357381     History of Changes
Other Study ID Numbers: SpringTMSUSPMOS 2014-01
Study First Received: February 3, 2015
Last Updated: October 9, 2015

Additional relevant MeSH terms:
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 28, 2017