NCT02357381

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
263

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 6, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

June 18, 2021

Status Verified

April 1, 2015

Enrollment Period

1.6 years

First QC Date

February 3, 2015

Last Update Submit

June 13, 2021

Conditions

Headache

Outcome Measures

Primary Outcomes (1)

  • Headache Days

    Reduction in mean headache days

    3 months

Study Arms (1)

TMS Treatment

TMS( transcranial magnetic stimulation) -treatment for headache

Device: eNeura SpringTMS

Interventions

eNeura SpringTMSDEVICE

Single pulse magnetic stimulation for prevention and/or treatment of migraine headache with or without aura.

TMS Treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

4-25 headache days per month (confirmed by 1-month baseline diary, minimum of 5 complete headache-free days/month)

You may qualify if:

  • Patients 18 to 65 years of age;
  • Patients able to understand and communicate in English;
  • Migraine with or without aura;
  • headache days per month (confirmed by 1-month baseline diary, minimum of 5 complete headache-free days/month);
  • Understand and willing to provide diary and survey data.

You may not qualify if:

  • Subjects will be excluded from participating in this trial if they meet any of the following criteria
  • Severe co-existing disease having a life expectancy of less than 1 year;
  • Currently involved in any other investigational clinical trials that have not completed their primary endpoint or that may interfere with the SpringTMS study results;
  • 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;
  • Known drug and/or alcohol addiction or use of illicit substances;
  • Patients with epilepsy or history of seizure;
  • Severe active major depression or major psychiatric illness;
  • Concurrent use of other neurostimulation devices (Cefaly®, TENS, implantable devices);
  • Use of Botox® within past 4 months;
  • Extracranial nerve block (e.g. occipital, supraorbital) within past 3 months;
  • Use of Cefaly for prevention within past month;
  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

UCLA Headache Research and Treatment Program

Los Angeles, California, 90095, United States

Location

Stanford Headache Program

Stanford, California, 94563, United States

Location

Mid Atlantic Permanente Medical Group-Kaiser

Rockville, Maryland, 20852, United States

Location

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

The Cleveland Clinic Center for Headache and Pain

Cleveland, Ohio, 44106, United States

Location

Jefferson Headache Center

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

  • 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.

    PMID: 29504483DERIVED

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • David W Dodick, MD

    Mayo Clinic , Phoenix,AZ

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2015

First Posted

February 6, 2015

Study Start

December 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

June 18, 2021

Record last verified: 2015-04

Locations

US(7)