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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05638191
Recruitment Status : Recruiting
First Posted : December 6, 2022
Last Update Posted : December 6, 2022
Queen's University
Dalhousie University
University of Toronto
Wings for Life
Information provided by (Responsible Party):
Michael Berger, University of British Columbia

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.

Condition or disease
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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Nerve Transfer Surgery to Restore Upper-limb Function After Ceervical Spinal Cord Injury
Actual Study Start Date : June 3, 2021
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) [ Time Frame: Baseline then every 3 months for 2 years ]
    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.

Secondary Outcome Measures :
  1. Modified Ashworth scores (MAS) [ Time Frame: Baseline then every 3 months for 2 years ]
    Modified Ashworth Scale (MAS) have been utilized in spinal cord injury patient population to assess spasticity by examining muscle tones.

  2. Range of Motion [ Time Frame: Baseline then every 3 months for 2 years ]
    A Goniometer is used to measure range of motion of the joint angles (degrees) from the axis of the joint. The measurement of joint movements is compared to its full potential.

  3. Ultrasound [ Time Frame: Baseline then every 3 months for 2 years ]
    Ultrasound imaging to assess the structural health of recipient muscles and to quantify muscle fibrosis and atrophy.

  4. Spinal Cord Independence Measure (SCIM) [ Time Frame: Baseline then every 3 months for 2 years ]
    The SCIM 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.

  5. Douleur Neuropathique 4 (DN-4) [ Time Frame: Baseline then every 3 months for 2 years ]
    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.

  6. Beck's Depression Inventory (BDI) [ Time Frame: Baseline then every 3 months for 2 years ]
    The questionnaire is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05638191

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Contact: Michael Berger, MD, PhD 778-990-7615 michael.berger@vch.ca

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Canada, British Columbia
GF Strong Rehabilitation Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 2G9
Contact: Harvey Wu, MD       harvey.wu@ubc.ca   
Principal Investigator: Michael Berger, MD, PhD         
Sub-Investigator: Russell O'Connor, MD         
Sub-Investigator: Erin Brown, MD         
Sub-Investigator: Chris Doherty, MD         
Sub-Investigator: Amy Hanlan, MD         
Canada, Nova Scotia
QEII Health Sciences Centre Not yet recruiting
Halifax, Nova Scotia, Canada, B3H 3A7
Contact: Emily Krauss         
Principal Investigator: Emily Krauss, MD, MSc         
Canada, Ontario
Kingston Health Sciences Centre Not yet recruiting
Kingston, Ontario, Canada, K7L 5G2
Contact: Michael Hendry, MD, MSc         
Principal Investigator: Michael Hendry, MD, MSc         
Sunnybrook Health Sciences Centre Not yet recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Jana Dengler, MD, MASc         
Principal Investigator: Jana Dengler, MD, MASc         
Sponsors and Collaborators
University of British Columbia
Queen's University
Dalhousie University
University of Toronto
Wings for Life
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Principal Investigator: Michael Berger, MD, PHD University of British Columbia
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Responsible Party: Michael Berger, Clinical Assistant Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT05638191    
Other Study ID Numbers: H20-03350
First Posted: December 6, 2022    Key Record Dates
Last Update Posted: December 6, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The IPD sharing plan is under discussion.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Berger, University of British Columbia:
spinal cord injury
upper extremity nerve transfer
nerve transfer
nerve reconstruction
Additional relevant MeSH terms:
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Muscle Weakness
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Neurologic Manifestations
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Pathologic Processes