eNeura SpringTMS Post-Market Observational US Study of Migraine

Completed

• Conditions: Headache
• Interventions: Device: eNeura SpringTMS

• Registration Number: NCT02357381
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-12-01
• Study First Submitted: 2015-02-03
• Study First Submitted QC: 2015-02-05
• Study First Posted: 2015-02-06
• Status Verified: 2015-04
• Primary Completion: 2016-07-01
• Study Completion: 2016-07-01
• Last Update Submitted: 2021-06-13
• Last Update Posted: 2021-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 263

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TMS Treatment	eNeura SpringTMS	TMS( transcranial magnetic stimulation) -treatment for headache

Primary Outcome Measures

Name	Time	Method
Headache Days	3 months	Reduction in mean headache days

Trial Locations

Locations (7)

Albert Einstein College of Medicine; 🇺🇸 Bronx, New York, United States

UCLA Headache Research and Treatment Program; 🇺🇸 Los Angeles, California, United States

Mid Atlantic Permanente Medical Group-Kaiser; 🇺🇸 Rockville, Maryland, United States

Mayo Clinic; 🇺🇸 Phoenix, Arizona, United States

Stanford Headache Program; 🇺🇸 Stanford, California, United States

The Cleveland Clinic Center for Headache and Pain; 🇺🇸 Cleveland, Ohio, United States

Jefferson Headache Center; 🇺🇸 Philadelphia, Pennsylvania, United States