Nerve Transfer After Spinal Cord Injury- Multi-center

NCT04023591 | Active Not Recruiting DMC

• 1 other identifier: SC180063
• Study Type: observational
• Target: 70
• Locations: 2 countries
• Sites: 9

Brief Summary

Current treatment strategies of acute cervical spinal cord injuries remain limited. Treatment options that provide meaningful improvements in patient quality of like 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 spinal cord injuries with no hand function. Optimize the efficiency of nerve transfer surgery by evaluating patient outcomes in relation to patient selection and quality of life and functional independence.

Conditions

Tetraplegia; Spinal Cord Injuries; Quadriplegia Flaccid

Keywords

tetraplegia; spinal cord injury; quadriplegia; nerve transfer

Outcome Measures

Primary Outcomes (2)

• Manual Motor Testing

  Change from baseline testing strength of upper extremities at 48 months post-operatively

  48 months

• Handheld Dynamometry

  Change from baseline grip strength at 48 months post-operatively

  48 months

Secondary Outcomes (7)

• Change in Disabilities of Arm, Shoulder and Hand (DASH) scores

  48 months

• Change in Spinal Cord Injury Quality of Life (SCIQOL) scores

  48 months

• Rates of Intra-operative and post-operative complications

  48 months

• Hand Function, measured by the GRASSP test

  48 months

• Changes in the Graded Redefined Assessment of Strength, Sensation and Prehension scores (GRASSP)

  48 months

Study Arms (1)

Surgery

Surgery/ Occupational Therapy

Procedure: Surgery/Occupational Therapy

Interventions

Surgery/Occupational Therapy PROCEDURE

Surgery based on function and injury/ Occupational therapy for 48 months post-surgery

Surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with a traumatic cervical spine injury with little to no use of his/her arms/hands.

You may qualify if:

• Age 18-65, inclusive
• At least 3 months of non-operative rehab therapy
• Mentally and physically willing and able to comply with evaluations
• Less than 36 months post-injury
• Stable ASIA scores with no evidence of functional improvement in motor or sensory examination for at least 3 months
• ASIA A or B determined by the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
• EMG/NCS verifies intact innervation (normal CMAPs) to the paralyzed target muscles below the level of injury
• Functional electrical stimulation (FES) will be performed. Subject must have clinically normal MRC grade 5/5 donor (axonal) function
• Injury Level C4-C8

You may not qualify if:

• Active infection at the operative site or systemic infection
• Any return or ongoing clinical recovery of distal motor function
• Mentally or physically compromised that will prevent them from complying with evaluations.
• Immunologically suppressed
• Currently undergoing long-term steroid therapy
• Active malignancy
• Pregnant
• Significant joint contractures and/or limitations in passive range of motion in the arm or hand, per treating surgeon's discretion
• Lack of appropriate social support and/or infrastructure to commit to scheduled follow-up visits.
• Patients who are planning on undergoing a tendon transfer during the study period or who have had a tendon transfer in the past.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Stanford University: collaborator
• University of Pennsylvania: collaborator
• University of Michigan: collaborator
• University of Calgary: collaborator
• University of Utah: collaborator
• United States Department of Defense: collaborator
• The Methodist Hospital Research Institute: collaborator
• University of Miami: collaborator
• University of Alberta: collaborator

Study Sites (9)

Stanford University

Stanford, California, 94305, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Alberta Health Services - Foothills Medical Center

Calgary, Alberta, T2N 2T9, Canada

Location

University of Alberta

Edmonton, Alberta, T6G 2E1, Canada

Location

Related Links

• Washington University Neurosurgery Website

MeSH Terms

Conditions

Quadriplegia; Spinal Cord Injuries

Interventions

Surgical Procedures, Operative; Occupational Therapy

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Wilson Z Ray, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 17, 2019
• Study Start: April 13, 2020
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); US (7)