A novel temporary peripheral nerve stimulation system that delivers a single dose of electrical stimulation therapy for 1 hour will be evaluated for safety and effectiveness.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
110
Single use medical device. Therapy consists of single, 1 hour dose of electrical stimulation delivered proximal to injury site.
Single use medical device. Sham treatment consists of single, 1 hour dose of sham stimulation.
University of Florida Health
Gainesville, Florida, United States
RECRUITINGOrlando Health Jewett Orthopedic Institute
Orlando, Florida, United States
Sensory recovery
Time frame: 6 months
Cumulative incidence of adverse events
Time frame: 6 months
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Louisiana State University Health Sciences Center
New Orleans, Louisiana, United States
RECRUITINGThe Curtis National Hand Center
Baltimore, Maryland, United States
COMPLETEDWellSpan Health
York, Pennsylvania, United States
COMPLETEDJohn Peter Smith Hospital
Fort Worth, Texas, United States
RECRUITINGUniversity of Alberta Hospital
Edmonton, Alberta, Canada
COMPLETEDSaint John Regional Hospital
Saint John, New Brunswick, Canada
RECRUITINGHamilton General Hospital
Hamilton, Ontario, Canada
RECRUITINGSt. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
RECRUITING...and 5 more locations