HeadacheESPOUSENCT02357381
eNeura SpringTMS Post-Market Observational US Study of Migraine
An observational study of Headache, run by eNeura, Inc. at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Headache
- What is being tested?
- eNeura SpringTMS
- Type of treatment
- Medical device
- How many people
- 263 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Dec 2014to 1 Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 4-25 headache days per month (confirmed by 1-month baseline diary, minimum of 5 complete headache-free days/month)
Who may be able to join
- Patients 18 to 65 years of age;
- Patients able to understand and communicate in English;
- Migraine with or without aura;
- 4-25 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.
Who cannot join
- 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;
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- 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
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
The Cleveland Clinic Center for Headache and Pain
Cleveland, Ohio, 44106
UCLA Headache Research and Treatment Program
Los Angeles, California, 90095
Jefferson Headache Center
Philadelphia, Pennsylvania, 19107
Mayo Clinic
Phoenix, Arizona, 85054
Mid Atlantic Permanente Medical Group-Kaiser
Rockville, Maryland, 20852
Stanford Headache Program
Stanford, California, 94563
Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
Official title: 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.
Read the 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:
- Use of the device to evaluate the potential for regular use of sTMS to reduce the frequency, severity, and/or duration of migraine.
- Delivery of additional treatments (pulses) to evaluate the acute treatment efficacy of breakthrough migraine attacks with and without aura.
- Conditions
- Headache
- Being tested
- eNeura SpringTMS
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eNeura SpringTMSDevice
Single pulse magnetic stimulation for prevention and/or treatment of migraine headache with or without aura.
| Study group | Role | What they receive |
|---|---|---|
| TMS Treatment | TMS( transcranial magnetic stimulation) -treatment for headache Receives: Device: eNeura SpringTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Days
Reduction in mean headache days
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study start1 Dec 2014
- Primary completion1 Jul 2016
- Study completion1 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- eNeura, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David W Dodick, MD, Principal investigator, Mayo Clinic , Phoenix,AZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02357381
- Sponsor's protocol ID
- SpringTMSUSPMOS 2014-01
- Acronym
- ESPOUSE
- Status last verified
- Apr 2015
- First submitted
- 3 Feb 2015
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 29504483
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- eNeura SpringTMS Post-Market Observational U.S. Study of Migraine
- ClinicalTrials.gov ID
- NCT02357381
- Acronym / sponsor ID
- ESPOUSE / SpringTMSUSPMOS 2014-01
- Conditions
- Headache
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- eNeura, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 1 Jul 2016 (actual)
- First posted
- 6 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Use of the device to evaluate the potential for regular use of sTMS to reduce the frequency, severity, and/or duration of migraine.
- Delivery of additional treatments (pulses) to evaluate the acute treatment efficacy of breakthrough migraine attacks with and without aura.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TMS Treatment | – | Device: eNeura SpringTMSTMS( transcranial magnetic stimulation) -treatment for headache |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 4-25 headache days per month (confirmed by 1-month baseline diary, minimum of 5 complete headache-free days/month)
Key inclusion criteria (5 listed)
- Patients 18 to 65 years of age;
- Patients able to understand and communicate in English;
- Migraine with or without aura;
- 4-25 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.
Key exclusion criteria (20 listed)
- Subjects will be excluded from participating in this trial if they meet any of the following criteria
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eNeura SpringTMSSingle pulse magnetic stimulation for prevention and/or treatment of migraine headache with or without aura. | Device | TMS Treatment |
Primary outcome
Headache Days
Time frame: 3 months
Reduction in mean headache days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Derived from this study: PubMed 29504483Starling 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David W Dodick, MD principal investigator
Mayo Clinic , Phoenix,AZ
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Headache, run by eNeura, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache Days (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02357381, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.