CRISP
Research type
Research Study
Full title
CompaRison of paresthesia mapping to anatomIc midline-based burSt Programming strategies
IRAS ID
208500
Contact name
Jeff Kramer
Contact email
Sponsor organisation
St Jude Medical
Duration of Study in the UK
2 years, 0 months, 2 days
Research summary
This study is for implantable medical device treatment of patients with back pain that have failed to respond to conventional therapy. It will study the effects of electrical stimulation of the spine to suppress pain.
The primary purpose of this study is to compare the therapeutic efficacy of the conventional, paresthesia (tingling feeling) mapping-based burst spinal cord stimulation (SCS) implantation strategy to a more novel, anatomic midline-based approach that has the potential to reduce the time taken for the device implantation and also allow the patient to be sedated throughout the procedure.
Failed back surgery syndrome (FBSS) subjects with predominant low back pain eligible for a SCS trial will be considered for enrollment in this study.
The study will last two years – one year inclusion period and one year follow-up.
The study will be conducted in up to three sites in Europe and enrol 50 subjects. Enrolment will stop when 40 participants have received devices.The patient visits will be enrollment, implant, 3, 6 and 12 month follow-ups.
REC name
North East - York Research Ethics Committee
REC reference
16/NE/0201
Date of REC Opinion
28 Jul 2016
REC opinion
Further Information Favourable Opinion