50
Participants
Start Date
August 1, 2022
Primary Completion Date
June 1, 2026
Study Completion Date
June 1, 2026
tSpinalStim
Patients will undergo 12-21 sessions of spinal cord stimulation therapy (30 minutes per session, 3 times a week). Up to five round stimulating electrodes will be placed on the skin midline between spinous processes in cervical, thoracic and/or lumbar region, as cathodes and rectangular pads will be placed symmetrically on the skin over the iliac crests as anodes. The stimulator generates pain-free biphasic rectangular waveform with 1 ms width pulses filled with 5-10 kHz (kilohertz) carrier frequency. A range of stimulation intensities from 0-250 mA (milliamps) may be used. We expect that the stimulation intensities needed for therapeutic effect may differ based on individual's body mass index and/or the amount of subcutaneous fat present at the stimulation site.
RECRUITING
San Francisco VA Medical Center, San Francisco
National Science Foundation Center for Disruptive Musculoskeletal Innovations
UNKNOWN
University of California, San Francisco
OTHER