Clinical trial NCT01714349: Nerve Transfer After Spinal Cord Injuries
Official title: Restoring Hand Function Using Nerve Transfers in Persons With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: Spinal cord injury
nerve transfer
tetraplegia
quadriplegia
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2012-10-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in upper motor strength
timeFrame: 48 months
Secondary outcomes:
measure: Change in Disabilities of Arm, Shoulder, and Hand (DASH) scores
timeFrame: 48 months
measure: Change in Short Form 36 (SF-36) scores
timeFrame: 48 months
measure: Change in Michigan Hand Questionnaire (MHQ)
timeFrame: 48 months
Other outcomes:
measure: Rates of Intraoperative and Post-operative complications
timeFrame: 48 months
measure: Effect of timing on surgical intervention
timeFrame: 48 months
measure: Rate of reoperation
timeFrame: 48 months
measure: Hand Function, measured by the Sollerman Hand Function Test
timeFrame: 48 months
Locations:
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Wilson Z Ray, MD
role: PRINCIPAL_INVESTIGATOR
References: