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

NCT05638191 | Unknown

• 1 other identifier: H20-03350
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 4

Brief Summary

The goal of this prospective, open label cohort study is to assess functional and motor outcomes in individuals with cervical spinal cord injury who have undergone nerve transfer surgery, with the goal of increasing upper limb function. We will also compare these outcomes to a cohort of similarly matched individuals who have not undergone nerve transfer surgery, using robust outcome measures, rigorous pre-operative clinical and neurophysiological assessments, and standardized rehabilitation. At the end of this project we aim to develop a model for predicting nerve transfer outcomes using pre-operative clinical and neurophysiological characteristics.

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)

• Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)

  A validated upper limb functional measures 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 (6)

• Modified Ashworth scores (MAS)

  Baseline then every 3 months for 2 years

• Range of Motion

  Baseline then every 3 months for 2 years

• Ultrasound

  Baseline then every 3 months for 2 years

• Spinal Cord Independence Measure (SCIM)

  Baseline then every 3 months for 2 years

• Douleur Neuropathique 4 (DN-4)

  Baseline then every 3 months for 2 years

Study Arms (2)

Experiemental: 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.

Control: Non-surgical

Individuals in this group will not have undergone nerve transfer surgery. They will be observed for two years post injury while receiving standard of care including medical and rehabilitation. We want to reinforce that individuals are not being randomized to surgery versus non-surgery. Rather individuals this group will either have made the decision not to undergo surgery, independent their participation in this study.

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:

• Motor complete (AIS A or B) between neurological level of injury C5 and C8
• Able to provide informed written consent
• Able to attend and comply with the testing protocols
• Able to understand and speak English or have access to an appropriate interpreter as judged by the investigator.

You may not qualify if:

• An uncontrolled medical condition (e.g. uncontrolled cardiovascular disease, diabetes, kidney or liver disease)
• Have ever received botulinum toxin injections (Botox) for tone management in the upper limb
• An unmanaged secondary complication of SCI including but not limited to uncontrolled neuropathic pain or spasticity, syringomyelia, fracture, urinary tract infection or significant pressure ulcer, preventing participation in testing

Sponsors & Collaborators

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

NOT YET RECRUITING

Kingston Health Sciences Centre

Kingston, Ontario, K7L 5G2, Canada

NOT YET RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

NOT YET 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: January 1, 2024
• Study Completion: January 1, 2026
• Last Updated: December 6, 2022

Record last verified: 2022-12

Locations

CA (4)