Evaluation of Advanced Lower Extremity Neuroprostheses
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of this study is to evaluate a surgically implanted functional electrical stimulation (FES) system to facilitate exercise, standing, stepping and/or balance in people with various degrees of paralysis.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 75
Healthy Volunteers: f
View:
• Skeletal maturity and ability to sign informed consent (\>18 years)
• Non-ventilator dependent paralysis resulting from injuries such as: mid cervical/thoracic (C4 or below) spinal cord injuries, poststroke hemiparesis, TBI, or MS, affecting the trunk and/or lower limbs
• Innervated and excitable lower extremity and trunk musculature
• Adequate social support and stability
• Willingness to comply with follow-up procedures
Locations
United States
Ohio
Louis Stokes Cleveland VA Medical Center
RECRUITING
Cleveland
MetroHealth System
RECRUITING
Cleveland
Contact Information
Primary
Lisa M Lombardo, MPT
lisa.lombardo2@va.gov
216-791-3800
Backup
Maura Malenchek, PTA
maura.malencheck@va.gov
216-791-3800
Time Frame
Start Date: 2018-06-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 10
Treatments
Experimental: Implant
Volunteers are evaluated for appropriateness for inclusion in the study on an intent-to-treat basis. Qualifying candidates all receive the implanted neuroprosthesis and participate in post-operative training and follow-up procedures.
Related Therapeutic Areas
Sponsors
Leads: Case Western Reserve University