Nerve Transfer After Spinal Cord Injuries

Not Applicable

Completed

• Conditions: Spinal Cord Injury
• Interventions: Procedure: Nerve Transfer

• Registration Number: NCT01714349
• Lead Sponsor: Washington University School of Medicine

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-22
• Study First Submitted QC: 2012-10-22
• Study First Posted: 2012-10-25
• Status Verified: 2023-03
• Primary Completion: 2023-03-20
• Study Completion: 2023-03-20
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nerve Transfer	Nerve Transfer	Surgical - Nerve transfers for patients with stable cervical spinal cord injuries

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Washington University; 🇺🇸 Saint Louis, Missouri, United States