58
Participants
Start Date
April 30, 2015
Primary Completion Date
June 30, 2017
Study Completion Date
June 30, 2017
ApexM
Subjects will apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity is set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. At the target amplitude, patients will feel a non-painful fluttering or tapping sensation, Subjects will perform this for 6 sessions per week at 12 minutes per session for an additional 12 weeks. At each follow-up visit, investigators will re-evaluate the stimulation level and adjust to avoid muscle contraction.
Sham Device
Identical to ApexM but will not deliver any electrical stimulation
Cleveland Clinic Foundation, Cleveland
The Cleveland Clinic
OTHER