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

eNeura SpringTMS Post-Market Observational U.S. Study of Migraine

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.

Study Overview

• Status: Completed
• Conditions: Headache
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 263

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Headache Research and Treatment Program
    • Stanford, California, United States, 94563
      • Stanford Headache Program
  • Maryland
    • Rockville, Maryland, United States, 20852
      • Mid Atlantic Permanente Medical Group-Kaiser
  • New York
    • Bronx, New York, United States, 10461
      • Albert Einstein College of Medicine
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • The Cleveland Clinic Center for Headache and Pain
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Jefferson Headache Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache Days	Reduction in mean headache days	3 months

Collaborators and Investigators

• Sponsor: eNeura, Inc.
• Investigators: Principal Investigator: David W Dodick, MD, Mayo Clinic , Phoenix,AZ

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: February 3, 2015
• First Submitted That Met QC Criteria: February 5, 2015
• First Posted (Estimate): February 6, 2015

Study Record Updates

• Last Update Posted (Actual): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 13, 2021
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Headache
• Other Study ID Numbers: SpringTMSUSPMOS 2014-01