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.
Brief Title
eNeura SpringTMS Post-Market Observational US Study of Migraine
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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Headache
Eligibility Criteria
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.
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.
Inclusion Criteria
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.
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.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
65 Years
Minimum Age
18 Years
NCT Id
NCT02357381
Org Class
Industry
Org Full Name
eNeura, Inc.
Org Study Id
SpringTMSUSPMOS 2014-01
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
eNeura SpringTMS Post-Market Observational U.S. Study of Migraine
Primary Outcomes
Outcome Description
Reduction in mean headache days
Outcome Measure
Headache Days
Outcome Time Frame
3 months
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
4-25 headache days per month (confirmed by 1-month baseline diary, minimum of 5 complete headache-free days/month)
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
65
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Matthew Robbins
Investigator Email
MAROBBIN@montefiore.org
Investigator Phone