Nerve Transfer After Spinal Cord Injuries

NCT ID: NCT01714349

Last Updated: 2023-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2023-03-20

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.

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nerve Transfer

Surgical - Nerve transfers for patients with stable cervical spinal cord injuries

Group Type: EXPERIMENTAL

Nerve Transfer

Intervention Type: PROCEDURE

A nerve transfer procedure will be individualized to each patient's functional deficit.

Interventions

Nerve Transfer

A nerve transfer procedure will be individualized to each patient's functional deficit.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wilson Z Ray, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University

St Louis, Missouri, United States

Countries

United States

Related Links

http://www.neurosurgery.wustl.edu

Washington University Neurosurgery Home Page

Other Identifiers

NTSCI -201208137

Identifier Type: -

Identifier Source: org_study_id