eNeura SpringTMS Post-Market Observational US Study of Migraine

Headache Clinical Trial

— ESPOUSE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02357381
• Other study ID #: SpringTMSUSPMOS 2014-01
• Status: Completed
• Start date: December 1, 2014
• Est. completion date: July 1, 2016

Study information

• Verified date: April 2015
• Source: eNeura, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: July 1, 2016
• Est. primary completion date: July 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache

Intervention

Device:
• eNeura SpringTMS
Single pulse magnetic stimulation for prevention and/or treatment of migraine headache with or without aura.

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine	Bronx	New York
United States	The Cleveland Clinic Center for Headache and Pain	Cleveland	Ohio
United States	UCLA Headache Research and Treatment Program	Los Angeles	California
United States	Jefferson Headache Center	Philadelphia	Pennsylvania
United States	Mayo Clinic	Phoenix	Arizona
United States	Mid Atlantic Permanente Medical Group-Kaiser	Rockville	Maryland
United States	Stanford Headache Program	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
eNeura, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache Days	Reduction in mean headache days	3 months