Nerve Transfer After Spinal Cord Injuries

Restoring Hand Function Using Nerve Transfers in Persons With Spinal Cord Injury

Nerve Transfer surgery can provide improved hand function following cervical spinal cord injuries

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Procedure: Nerve Transfer

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nerve Transfer; Surgical - Nerve transfers for patients with stable cervical spinal cord injuries	Procedure: Nerve Transfer; A nerve transfer procedure will be individualized to each patient's functional deficit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in upper motor strength	Patients motor strength will be assessed over 48 months of clinical follow-up with conventional manual motor testing	48 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Disabilities of Arm, Shoulder, and Hand (DASH) scores	The change in DASH scores will be followed over time and assessed pre-operatively, 6,12, 18, 24, 36 and 48 months post-operatively.	48 months
Change in Short Form 36 (SF-36) scores	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.	48 months
Change in Michigan Hand Questionnaire (MHQ)	The change in MHQ will be followed over time and assessed pre-operatively, 6, 12, 18, 24, 36 and 48 months post-operatively.	48 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of Intraoperative and Post-operative complications	The number of complications within and after the operation.	48 months
Effect of timing on surgical intervention	Assess the effect of timing on primary and secondary outcome measures, early (<12 months) vs. (>12 months)	48 months
Rate of reoperation	The rate at which a patient needs to be operated on again.	48 months
Hand Function, measured by the Sollerman Hand Function Test	The Sollerman Hand Function Test is performed as part of an overall evaluation and assessment by study team Occupational Therapist pre-operatively, post-operatively, and at 6 months, 12 months, 18 months, and 24 months. 36 months and 48 months	48 months

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: United States Department of Defense

Publications and helpful links

Helpful Links

• Washington University Neurosurgery Home Page

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): March 20, 2023
• Study Completion (Actual): March 20, 2023

Study Registration Dates

• First Submitted: October 22, 2012
• First Submitted That Met QC Criteria: October 22, 2012
• First Posted (Estimate): October 25, 2012

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: nerve transfer; quadriplegia; Spinal cord injury; tetraplegia
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: NTSCI -201208137