CA2014OUS CM Rev A 26 February 2015
Research type
Research Study
Full title
HF10 Spinal Cord Stimulation in the Treatment of Refractory Chronic Migraine
IRAS ID
143092
Contact name
Eric Boulogne
Contact email
Sponsor organisation
Nevro Corp.
Clinicaltrials.gov Identifier
CIV-15-04-013384, Eudamed Number; CI/2015/0020, MHRA Reference
Duration of Study in the UK
2 years, 6 months, 31 days
Research summary
Subjects participating in this study will undertake entry criteria evaluation, baseline assessments, device implantation and activation, and post-device activation assessments.
Subjects who sign the informed consent will have evaluations performed to determine eligibility for the study based on the inclusion and exclusion criteria. Baseline assessments will include measures for headache assessments (daily patient diary), medication use, disability, headache impact, quality of life and neurological assessment.
All eligible subjects will be implanted with an IPG (Implantable Pulse Generator) and lead(s), and undergo 52 weeks of stimulation with assessments done at 4, 8, 12, 24 and 52 weeks following activation.
Implantation and use of the HF10 SCS System will follow the Nevro Investigator Brochure, supporting manuals and site’s standard practice.
Following device implant, the IPG will be activated and thus, stimulation delivered on an ongoing basis for 12 months. The time between device implant and activation will be 4 weeks providing sufficient time for surgical wounds to heal and for implant medication to wash out. At each study visit, the subjects will be assessed for headache frequency, duration and intensity, as well as medication usage. At 12, 24 and 52 weeks post-device activation, the following evaluations will also be performed: disability, headache impact, quality of life and neurological assessments, subject satisfaction as well as Patient and Clinician Global Impression of Change. Adverse event monitoring will be performed at each visit.
All attempts will be made to optimize therapy delivery by identifying the stimulation settings providing maximal headache relief. All device programming will be performed by Nevro field clinical engineers.REC name
North East - York Research Ethics Committee
REC reference
15/NE/0168
Date of REC Opinion
26 May 2015
REC opinion
Further Information Favourable Opinion