Status:
TERMINATED
Restoring Hand Function Utilizing Nerve Transfers in Persons With Cervical Spinal Cord Injuries
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Cervical Spinal Cord Injury
Spinal Cord Injuries
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The primary objective of this study is to evaluate the safety and efficacy of nerve transfer surgery for restoring hand function as a therapy for patients with cervical spinal cord injury.
Eligibility Criteria
Inclusion
- American Spinal Injury Association (ASIA) grade of A, B, or C, or with a diagnosis of central cord syndrome, showing minimal to no evidence of functional improvement in motor examination after at least 6 months of non-operative therapy post-injury
- \>6 months post-injury
- International Classification of Surgery of the Hand in Tetraplegia (ICSHT) category 0-4
- Cervical spinal cord injury resulting in arm \& hand functional impairment, with at least preserved elbow flexion
- Physically and mentally willing and able to comply with study protocol
- Lives in the immediate area and has no plans to relocate
- Provides informed consent and HIPAA release of medical information
Exclusion
- Active infection
- Any return or ongoing clinical recovery of distal motor function within 6 months after injury
- Physically/mentally compromised
- Systemic disease that would affect the patient's welfare or the research study
- Immunologically suppressed or immunocompromised
- Currently undergoing long-term steroid therapy
- Active malignancy
- Pending litigation or receiving Workers Compensation related to injury or accident
- Pregnancy
- Significant contractures and/or limitations in passive range of motion in the arm or hand
- Poorly controlled upper extremity spasticity
- Uncontrolled pain or hypersensitivity
- Previous or current injury preventing use of tendon transfers to restore upper extremity function
- History of brachial plexus injury or systemic neuropathic process
- In the opinion of the Principal Investigator the subject would not be a candidate for the procedure
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2020
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT03451474
Start Date
April 1 2018
End Date
July 17 2020
Last Update
October 21 2021
Active Locations (1)
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1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030