Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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 Criteria

  • 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Upper extremity nerve transfer surgery
Upper extremity nerve transfer surgery is a surgical procedure where axons from an intact, functioning upper extremity peripheral nerve are moved to a target muscle that demonstrates significant weakness or paralysis as a result of spinal cord injury. After allowing time for recovery from surgery and for nerve growth to occur, the patient undergoes hand/occupational therapy in order to retrain motor skills.
  • Procedure: Upper extremity nerve transfer surgery
    Upper extremity nerve transfer surgery is a surgical procedure where axons from an intact, functioning upper extremity peripheral nerve are moved to a target muscle that demonstrates significant weakness or paralysis as a result of spinal cord injury. After allowing time for recovery from surgery and for nerve growth to occur, the patient undergoes hand/occupational therapy in order to retrain motor skills.

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Rebecca Martinez, RN
713-704-4137
Rebecca.Martinez@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Rebecca Martinez, RN
(713) 704-4137
Rebecca.Martinez@uth.tmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.