13
Participants
Start Date
November 3, 2016
Primary Completion Date
August 30, 2020
Study Completion Date
December 30, 2020
Ziconotide 100 MCG(microgram)/ML Intrathecal Solution
Initial dose at time of the implant will be 1.2 mcg/day with dose increases of no more the .4 mcg/day planned for 3, 6, 8, 9, 10, 12 weeks and 4, 5, 6 and 12 months.
Quantitative sensory testing
Quantitative sensory testing will be done using different types of sensory stimulation to objectively quantify sensation and pain tolerance. VonFrey fibers of various widths are used to detect sensation, a Neuropen pin prick iutilized to detect pain, along with a tuning fork to measure vibrationand a pressure guage to measure pressure felt on the skin. Cold/hot sensation is tested with Medoc Pathway system to quantitatively measure the temperature felt by patients to be done at baseline, 6 months and 12 months,
Serum markers: Interleukin-1, Interleukin-6, and tumor necrosis factor
Increases in these biomarkers indicate nerve pain as they are released from macrophages in patients with damaged nerves.
Albany Medical College, Albany
Lead Sponsor
Albany Medical College
OTHER