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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.

Tracking Information
First Submitted Date February 3, 2015
First Posted Date February 6, 2015
Last Update Posted Date June 18, 2021
Actual Study Start Date December 1, 2014
Actual Primary Completion Date July 1, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 5, 2015)
Headache Days [ Time Frame: 3 months ]
Reduction in mean headache days
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title eNeura SpringTMS Post-Market Observational US Study of Migraine
Official Title eNeura SpringTMS Post-Market Observational U.S. Study of Migraine
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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)
Condition Headache
Intervention Device: eNeura SpringTMS
Single pulse magnetic stimulation for prevention and/or treatment of migraine headache with or without aura.
Study Groups/Cohorts TMS Treatment
TMS( transcranial magnetic stimulation) -treatment for headache
Intervention: Device: eNeura SpringTMS
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 13, 2021)
263
Original Estimated Enrollment
 (submitted: February 5, 2015)
250
Actual Study Completion Date July 1, 2016
Actual Primary Completion Date July 1, 2016   (Final data collection date for primary outcome measure)
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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02357381
Other Study ID Numbers SpringTMSUSPMOS 2014-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party eNeura, Inc.
Study Sponsor eNeura, Inc.
Collaborators Not Provided
Investigators
Principal Investigator: David W Dodick, MD Mayo Clinic , Phoenix,AZ
PRS Account eNeura, Inc.
Verification Date April 2015