Spinal Cord Injury
Conditions
Keywords
Spinal cord injury, nerve transfer, tetraplegia, quadriplegia
Brief summary
Nerve Transfer surgery can provide improved hand function following cervical spinal cord injuries
Detailed description
Current treatment strategies of acute cervical spinal cord injuries remain limited. Treatment options that provide meaningful improvements in patient quality of life and long-term functional independence will provide a significant public health impact. Specific Aim: Measure the efficacy of nerve transfer surgery in the treatment of patients with complete cervical spinal cord injuries with no hand function. Optimize the efficiency of nerve transfer surgery by evaluating patient outcomes in relation to patient selection and optimal timing the the surgery. Hypothesis: Peripheral nerve transfers in patients with spinal cord injuries will improve hand function and provide improvement in patient quality of life and functional independence.
Interventions
PROCEDURENerve Transfer
A nerve transfer procedure will be individualized to each patient's functional deficit.
Sponsors
Washington University School of Medicine
United States Department of Defense
CDMRP
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. 18-65 years of age 2. Informed Consent Document (ICD) signed by patient 3. Cervical spinal cord injury resulting in arm \& hand functional impairment, with at least preserved elbow function 4. International Classification of Surgery of the Hand in Tetraplegia (ICSHT) category 0 - 4 5. Patients with a stable 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. Appropriate candidate for nerve transfer study 7. Willing and able to comply with the study protocol 8. \< 48 months from injury
Exclusion criteria
1. Active infection at the operative site or systemic infection 2. Any return or ongoing clinical recovery of distal motor function within 6 months after injury 3. Physically or mentally compromised 4. Currently undergoing long-term steroid therapy 5. Significant joint contractures and/or limitations in passive range of motion in the arm or hand 6. Active malignancy 7. Systemic disease that would affect the patient's welfare or the research study 8. Pregnant 9. Immunologically suppressed or immunocompromised 10. Significant pain or hypersensitivity 11. Previous or current injury preventing use of tendon transfers to restore upper extremity function 12. Affective disorder of a degree that would make outcome assessment and study participation difficult 13. History of brachial plexus injury or systemic neuropathic process
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in upper motor strength | 48 months | Patients motor strength will be assessed over 48 months of clinical follow-up with conventional manual motor testing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Disabilities of Arm, Shoulder, and Hand (DASH) scores | 48 months | The change in DASH scores will be followed over time and assessed pre-operatively, 6,12, 18, 24, 36 and 48 months post-operatively. |
| Change in Short Form 36 (SF-36) scores | 48 months | The change in SF-36 scores will be followed over time and assessed pre-operatively, 6, 12, 18, 24. 36 and 48 months post-operatively. |
| Change in Michigan Hand Questionnaire (MHQ) | 48 months | The change in MHQ will be followed over time and assessed pre-operatively, 6, 12, 18, 24, 36 and 48 months post-operatively. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORWilson Z Ray, MD
Washington University School of Medicine
Outcome results
None listed