Here is new information from the NIBIB website about spinal cord stimulation research.
“The purpose of this webinar was to alert the community working on spinal stimulation for spinal cord injury that the SPARC Initiative provides an excellent funding opportunity for advancing the field. The presentation focused on the priorities outlined in the Spinal Stimulation Framework Report, specifically the need to conduct coordinated human studies to gather objective evidence of the potential of spinal stimulation to restore bladder, bowel and sexual function to individuals with spinal cord injury.
NIBIB described the need for a controlled, multi-site pilot clinical study of spinal stimulation in spinal cord injury subjects. The study design would be guided by the ultimate goal of gathering sufficient safety, efficacy and other data to inform the conduct of a future definitive trial for FDA approval or clearance of a market-approved spinal stimulation device. NIBIB outlined possible considerations for designing a pilot study, including the need to establish the most efficient route to identify an effective, transferrable treatment approach, with bladder, bowel and sexual function as primary outcomes. These include coordinated functional mapping studies to optimize the parameters for spinal stimulation to effect control of bladder, bowel, and sexual function in individuals with spinal cord injury. Additionally, it is important to specify the minimum number of subjects and trial sites to generate sufficient pilot data for a future large scale trial, and optimize a treatment approach for maximum scalability. Such a study could be supported through the SPARC RFA-RM-15-003 which has multiple pre-application receipt deadlines.
Although the NIBIB Consortium focused on epidural stimulation in its framework report, NIBIB and SPARC encourage other approaches, such as trans-cutaneous stimulation, providing there is sufficient supporting preliminary data of safety and efficacy in restoring bladder, bowel and sexual function. Ideally, investigative teams would assemble around an agreed-upon pilot study design to develop a pre-application to SPARC. It should be noted that the SPARC funding mechanism, known as Other Transaction Authority, enables discussion with NIH staff before and after the pre-application submission to aid in the development of a competitive application.”
Here is the LINK to the 2015 SPARC Strategic Planning Workshop: Biology and Technology