Treatment of Pain and Autonomic Dysreflexia in Spinal Cord Injury with Deep Brain Stimulation
Abstract
This project aims to study electrical deep brain stimulation as a method for treating pain and autonomic dysflexia in patients with chronic spinal cord injury. It consists of a collaboration between the University of Miami and the Miami Veterans Administration Hospital. It involves an invasive surgical procedure performed at the University of Miami Hospital. All 8 subjects will be patients of the spinal cord clinic of the Miami VAH. Testing for pain and other symptoms of spinal cord injury will be done at both sites. Since this project entails critical invasive surgery and pain measurement, the first year was taken up with obtaining regulatory approval consecutively from the FDA (an investigative device exemption) and from the IRBs of the two sites. These processes involved considerable back-and-forth discussion and revision of protocols. All approvals have now been obtained: FDA conditional approval 20 December 2012, amended 10 May 2013, University of Miami IRB 16 July 2012, Miami VAH IRB 18 September 2013. Recruitment of subjects is now planned to begin in December 2013. We anticipate completing all proposed procedures and testing within the 3 years of the funded grant.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2013
- Accession Number
- ADA600687
Entities
People
- Ian D. Hentall
- Jonathan R. Jagid
Organizations
- University of Miami