SENZA SCI
Research type
Research Study
Full title
HF10 Therapy for the Treatment of Chronic Pain Resulting from Spinal Cord Injury
IRAS ID
210874
Contact name
Sam Eldabe
Contact email
Sponsor organisation
Nevro Corp
Duration of Study in the UK
2 years, 2 months, 0 days
Research summary
The Senza system is being used according to its approved guidelines and provided to the subjects as it would under normal practice. The implantation technique and use of the Senza System will follow the Nevro Physician's and Patient’s Manuals.
Subjects who sign the informed consent will be evaluated for eligibility, based on the study inclusion and exclusion criteria. Baseline assessments will measure for pain, neurological/sensorimotor state, neuropathic pain, spasticity, spinal cord independence, quality of life, sleep disturbance, depression and medication use. Subjects will then undergo the trial phase to assess their response to the therapy. The subject’s pain scores will be compared to those recorded at baseline and those who have a "Successful Trial Phase" (≥ 50% pain reduction from baseline in their target pain area) will receive a permanent implant.
Following device implant, the device is activated and stimulation delivered for 12 months. The time between implant and activation will be as per the site’s routine practice (approximately 2 weeks), which will provide sufficient time for surgical wounds to heal and for implant medication to be eliminated from the body. Following this there will be 12 months of follow up visits at the clinic.
At every follow up visit, assessments of pain and adverse events will be made. The subject will visit the clinic and will be seen at 1, 3, 6, 9 and 12 months. Depending on the visit, assessments will be done and subjects will have to complete questionnaires. Paresthesia assessment (at 60 Hz, 500 Hz or low-frequency SCS) may be performed to assess lead location at 3 and 12 months. At every visit, all attempts to achieve the best possible pain relief therapy will be made based on the doctor’s advice. All device programming will be performed by Nevro field clinical engineers.
REC name
North East - York Research Ethics Committee
REC reference
16/NE/0315
Date of REC Opinion
26 Oct 2016
REC opinion
Further Information Favourable Opinion