Nerve Transfer Surgery to Restore Upper-limb Function After Cervical Spinal Cord Injury

NCT05638191 | Recruiting

• 1 other identifier: H20-03350
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 4

Brief Summary

The goal of this prospective, open-label cohort study is to assess functional outcomes in individuals with cervical spinal cord injury who have undergone nerve transfer surgery to restore upper limb function. The main questions it aims to answer are:

• Does nerve transfer improve hand function in individuals with cervical spinal cord injury?
• What factors are associated with functional improvement following nerve transfer? Researchers will compare functional outcomes at 24 months post-surgery to 1) baseline outcomes and 2) individuals with cervical spinal cord injury who did not undergo nerve transfer. Participants who have received nerve transfer surgery as part of their regular medical care will complete functional hand tests, electrodiagnostic assessments, and questionnaires on independence and mood every 3 months for 24 months after surgery.

Conditions

Spinal Cord Injury; Spinal Cord Injury at C5-C7 Level; SCI - Spinal Cord Injury; Upper Extremity Paralysis; Upper Extremity Dysfunction; Tetraplegia; Upper Extremity Paresis; Cervical Spinal Cord Injury

Keywords

spinal cord injury; upper extremity nerve transfer; nerve transfer; SCI; nerve reconstruction; quadriplegia; paresis

Outcome Measures

Primary Outcomes (1)

• GRASSP (within-participant)

  Change in Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) score from baseline to 24 months post-surgery. GRASSP is a validated upper limb functional measure and previously is used in SCI (Kalsi-Ryan et al. 2012) incorporates three domains vital to upper limb function: sensation, strength, and prehension.

  Baseline then every 3 months for 2 years

Secondary Outcomes (1)

• GRASSP (between-participant)

  From enrollment to the study endpoint

Other Outcomes (6)

• Donor nerve health

  Baseline

• Beck's Depression Inventory (BDI)

  Baseline then every 3 months for 2 years

• Douleur Neuropathique 4 (DN-4)

  Baseline then every 3 months for 2 years

Study Arms (2)

Experimental: Surgical Arm

Individuals in this group will receive nerve transfer surgery 6 - 9 months post cervical spine injury and be observed for two years post-operatively.

Procedure: Nerve transfer surgery

Control: Non-surgical

Historical control data will be drawn from a published multi-center longitudinal trial that assessed outcomes in individuals with acute traumatic cervical SCI within ten days of injury (baseline), and again at one, three, six, and 12 months post-injury (PMID: 35652348). The general inclusion criteria for this study was traumatic tetraplegia, at least 1/5 strength in the C5 myotome, age 16 years or older, and the ability to provide informed consent. Exclusion criteria included brain injury or other neurological impairments affecting upper limb function. Participants in the surgical cohort will be matched 1:1 with historical controls based on age, sex, and injury characteristics (i.e., NLI and AIS grade).

Interventions

Nerve transfer surgery PROCEDURE

The intervention in this study, which follows our clinical approach, is the "double nerve transfer" to restore grasp function (i.e., hand opening and hand closing). Finger and thumb extension (hand opening) is restored via the supinator-posterior interosseous nerve (PIN) transfer. Finger and thumb flexion (hand closing) is restored via a nerve transfer to the anterior interosseous nerve (AIN). There are two donor nerve options available to restore function to the muscles supplied by the AIN: the nerve to the brachialis and the nerve to the extensor carpi radialis longus (ECRL) or extensor carpi radialis brevis (ECRB).

Experimental: Surgical Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient referrals are ensured through established care pathways for upper-limb rehabilitation in SCI, including nerve transfer. Research objectives will be facilitated through already available institutional clinical and rehabilitation resources at each study site. Potential participants will be informed of the study directly by their treating physicians. The research study will be introduced by the PI or one of the co-Is of the study, who are also responsible for clinical care of all prospective participants.

You may qualify if:

• Traumatic, motor-complete cervical SCI (AIS A or B)
• Male or female, ages 18-70
• Consent and plan to undergo nerve transfer to restore grasp function in at least one limb
• Motor grade 4-5 at C5
• Motor grade 0-1 at C8/T1
• Injury duration within 6 months at the time of surgery
• English-speaking and cognitively intact
• Able to provide informed written consent
• Able to attend and comply with the testing protocols

You may not qualify if:

• Inability or unwillingness to participate in post-operative rehabilitation (in person or virtual)
• Secondary complication of SCI (e.g., intractable neuropathic pain, edema, contracture) or major medical comorbidity (e.g., traumatic brain injury) that would independently influence response to surgery or ability to participate in rehabilitation

Sponsors & Collaborators

• Dalhousie University: collaborator
• University of Toronto: collaborator
• Wings for Life: collaborator
• University of British Columbia: lead
• Queen's University: collaborator

Study Sites (4)

GF Strong Rehabilitation Hospital

Vancouver, British Columbia, V5Z 2G9, Canada

RECRUITING

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

RECRUITING

Kingston Health Sciences Centre

Kingston, Ontario, K7L 5G2, Canada

RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Quadriplegia; Paresis

Condition Hierarchy (Ancestors)

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

Study Officials

• Michael Berger, MD, PHD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Berger, MD, PhD

CONTACT

778-990-7615; michael.berger@vch.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: December 6, 2022
• Study Start: June 3, 2021
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 29, 2026

Record last verified: 2026-05

Locations

CA (4)