23
Participants
Start Date
October 31, 2016
Primary Completion Date
August 31, 2019
Study Completion Date
October 30, 2019
Peripheral Nerve Stimulation
The stimulation system includes an external stimulator, percutaneous lead and pad. The stimulator snaps onto the pad. The pad has an embedded power source but also serves as the anode. The 1-channel stimulator outputs a biphasic current waveform with current pulse parameter ranges suitable for PNS. The percutaneous lead is inserted using an introducer (like a hypodermic needle) which is withdrawn and the lead is retained in the muscle by a barb at its tip. After a 1-week stabilization period, stimulation is initiated (daily dose is Group-dependent). Stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period is 3 weeks after which the lead will be removed. Total time of electrode implantation is no more than 29 days.
MetroHealth Medical Center, Cleveland
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Case Western Reserve University
OTHER
MetroHealth Medical Center
OTHER