HF10™ spinal cord stimulation in the treatment of refractory chronic migraine
- Conditions
- Refractory chronic migraineNervous System DiseasesMigraine
- Registration Number
- ISRCTN94247798
- Lead Sponsor
- evro Corp.
- Brief Summary
2016 results in https://pubmed.ncbi.nlm.nih.gov/27393015 (added 13/03/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
1. Be 18 years of age or older at the time of enrollment.
2. Have been diagnosed with chronic migraine (CM) as per ICHD-2R criteria for at least 6 months as defined by the following:
2.1. Headache on = 15 days/month for at least 3 months.
2.2. At least five attacks fulfilling criteria for migraine without aura (ICHD-2 1.1).
2.3. On = 8 days/month for at least 3 months headache has fulfilled C1 and / or C2 below:
2.3.1. Has at least two of 2.3.1.1-2.3.1.4 (below):
2.3.1.1. Unilateral location
2.3.1.2. Pulsating quality
2.3.1.3. Moderate or severe pain intensity
2.3.1.4. Aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs) and at least one of 2.3.1.4.1. or 2.3.1.4.2. (below):
2.3.1.4.1. Nausea and/or vomiting
2.3.1.4.2. Photophobia and phonophobia
2.3.1.2. Treated and relieved by triptan(s) or ergot before the expected development of C1 above.
2.3.2. No medication overuse and not attributed to another causative disorder
3. Are refractory to conventional pharmacological CM treatment as defined by the failure to respond, or the intolerance, to at least 3 prophylaxis therapies (of which one is topiramate if not contraindicated).
4. Have failed botulinum toxin type A treatment, defined as less than a 30% reduction in headache days per month after two treatment cycles, at least 3 months apart, with the last treatment minimum 3 months ago
5. Are on optimal and stable CM prophylaxis therapy for at least 2 months.
6. Developed CM before the age of 60
7. Be an appropriate candidate for cervical SCS and for the surgical procedures required in this study based on the clinical judgment of the implanting physician
8. Be willing and able to comply with study-related requirements, procedures, and visits and to keep headache diaries
9. Be capable of subjective evaluation, able to read and understand English-written questionnaires, and are able to read, understand and sign the written inform consent in English
10.Have adequate cognitive ability to use a patient remote control and recharger as determined by the Investigator
1. Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
2. Have a contraindication to the cervical placement of SCS leads as determined by the investigator.
3. Have a PHQ-9 score of more than 19
4. Have previously diagnosed untreated severe psychiatric disorder(s)
5. Have a known history or suspicion of substance abuse or addiction (including alcohol and illicit drugs) as determined by the investigator
6. Have a current diagnosis of a progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, severe arachnoiditis, severe peripheral neuropathy, brain or spinal cord tumor, central deafferentation syndrome, Complex Regional Pain Syndrome, acute herniated disc, severe cervical spinal stenosis or other as determined by the investigator
7. Have a current diagnosis of a coagulation disorder, bleeding diathesis that would put patient at any increased risk of bleeding during SCS procedure, progressive peripheral vascular disease or uncontrolled diabetes mellitus
8. Have an existing drug pump and/or another active implantable device (switched On or Off) such as a pacemaker or other SCS devices
9. Non-invasive neuromodulation is being used or planned
10. Previous exposure to any implantable neurostimulation device
11. Alternative therapy to treat migraine is being used or planned (e.g. acupuncture, acupressure, biofeedback, homeopathy)
12. Have a condition currently requiring or likely to require the use of MRI or diathermy
13. Have metastatic malignant disease or active local malignant disease
14. Have a life expectancy of less than 1 year
15. Have an active systemic or local infection
16. Be pregnant or breast-feeding (Female subjects of child-bearing potential must have a HCG negative blood serum test prior to implant and must be willing to use an adequate method of birth-control for the duration of the study)
17. Be concomitantly participating or planned to be participating in another clinical study
18. Have a pending or approved worker’s compensation claim, and an ongoing planned litigation related to work
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Primary Effectiveness Measure: Change from baseline in number of moderate-to-severe headache days at 12 weeks post-device activation<br> 2. Primary Safety Measure: Incidence of unanticipated adverse device effects (UADEs) at 12 weeks post-device activation<br>
- Secondary Outcome Measures
Name Time Method