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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorUniversity of British Columbia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Nerve transfer surgery

    Procedure/Surgery

    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).

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Experimental: Surgical Arm1 intervention
Group B: Control: Non-surgical0 interventions

Trial outcomes

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.

Time frame
Baseline then every 3 months for 2 years

Secondary outcomes

1

GRASSP (between-participant)

Difference in longitudinal change in mean total GRASSP score between the surgical cohort and matched historical controls with cervical SCI who did not receive nerve transfer

Time frame
From enrollment to the study endpoint

Other outcomes

1

Donor nerve health

The presence (or absence) of pathological spontaneous activity will be determined in donor muscles using needle electromyography.

Time frame
Baseline
2

Beck's Depression Inventory (BDI)

The questionnaire is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.

Time frame
Baseline then every 3 months for 2 years
3

Douleur Neuropathique 4 (DN-4)

A questionnaire consisting of 10 items and can be useful in assessment of neuropathic pain. The items related to pain quality are based on an interview and examination of the patient.

Time frame
Baseline then every 3 months for 2 years
4

Spinal Cord Independence Measure Version III (SCIM-III)

The SCIM-III has been developed to address three specific areas of function in patients with spinal cord injuries such as activities of daily living, respiration and sphincter management, and a patient's mobility abilities.

Time frame
Baseline then every 3 months for 2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of British Columbia

Lead sponsor

Queen's University

Collaborator

Dalhousie University

Collaborator

University of Toronto

Collaborator

Wings for Life

Collaborator