Phase
Condition
Spinal Cord Injuries
Limb Spasticity
Treatment
Surgery/Occupational Therapy
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria
Age 18-65, inclusive
At least 3 months of non-operative rehab therapy
Mentally and physically willing and able to comply with evaluations
Less than 36 months post-injury
Stable ASIA scores with no evidence of functional improvement in motor or sensory examination for at least 3 months
ASIA A or B determined by the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
EMG/NCS verifies intact innervation (normal CMAPs) to the paralyzed target muscles below the level of injury
Functional electrical stimulation (FES) will be performed. Subject must have clinically normal MRC grade 5/5 donor (axonal) function
Injury Level C4-C8
Exclusion Criteria
Active infection at the operative site or systemic infection
Any return or ongoing clinical recovery of distal motor function
Mentally or physically compromised that will prevent them from complying with evaluations.
Immunologically suppressed
Currently undergoing long-term steroid therapy
Active malignancy
Pregnant
Significant joint contractures and/or limitations in passive range of motion in the arm or hand, per treating surgeon's discretion
Lack of appropriate social support and/or infrastructure to commit to scheduled follow-up visits.
Patients who are planning on undergoing a tendon transfer during the study period or who have had a tendon transfer in the past.
Study Design
Study Description
Connect with a study center
Alberta Health Services - Foothills Medical Center
Calgary, Alberta T2N 2T9
CanadaSite Not Available
University of Alberta
Edmonton, Alberta T6G 2E1
CanadaSite Not Available
Stanford University
Stanford, California 94305
United StatesSite Not Available
University of Miami
Miami, Florida 33136
United StatesSite Not Available
Johns Hopkins University
Baltimore, Maryland 21287
United StatesSite Not Available
University of Michigan
Ann Arbor, Michigan 48109
United StatesSite Not Available
Washington University
Saint Louis, Missouri 63110
United StatesSite Not Available
Duke University
Durham, North Carolina 27710
United StatesSite Not Available
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Houston Methodist
Houston, Texas 77030
United StatesSite Not Available
The University of Texas Houston Health Science Center
Houston, Texas 77030
United StatesSite Not Available
University of Utah
Salt Lake City, Utah 84132
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.