MRI is increasingly recognised as a valuable tool for assessing prognosis and predicting outcomes following traumatic spinal cord injury (SCI). Several potential MRI biomarkers have been identified, but efforts are still needed to improve the accuracy and feasibility of these biomarkers in clinical practice. This study aims to build a national Canadian SCI imaging repository for storing and analysing imaging data for SCI, with the goal of improving SCI MRI biomarkers to predict outcomes and inform clinical management.

As a substudy of the Rick Hansen SCI Registry (RHSCIR), this retrospective multisite study includes individuals who sustained a traumatic cervical SCI between 2015 and 2021, were previously enrolled in RHSCIR, and had MRI scans acquired within 72 hours of injury and before any surgical intervention. Individuals with a penetrating trauma and/or with any prior spine surgery are excluded. The study principal investigator and research associates, experienced with data curation and with the standardised format and specifications of the Brain Imaging Data Structure standard, guide the site’s curator on the steps to perform image deidentification and curation to create standardised datasets across all sites. These datasets are transferred to a Digital Research Alliance of Canada (‘the Alliance’) server designated for this project and concatenated to form the national Canadian SCI imaging repository (Neurogitea). We are using a semiautomated processing pipeline to quantify lesion morphology, together with additional imaging measures that are manually extracted from the images (for instance, the relative maximal spinal cord compression and the maximum canal compromise). Through linkage to RHSCIR clinical and epidemiological data already available on eligible participants, regression analysis is planned to predict neurological outcomes at discharge, including the American Spinal Injury Association Impairment Scale grade, upper and lower extremity motor and sensory scores.

This protocol has been submitted by the participating sites to obtain ethics and institutional approvals prior to the study initiation at each site. All 12 sites across Canada have now obtained ethics and institutional approvals. Study results will be disseminated at local, national and international conferences and by journal publications.

Dyspnoea affects 10% of the general population, and 12% of hospitalised patients report experiencing dyspnoea at rest. It is a common and distressing symptom experienced by people living with chronic obstructive pulmonary disease (COPD). Neuromodulation, which uses electrical stimulation to modulate neural pathways, is a validated clinical procedure offering a potential therapeutic approach. We speculate that non-invasive transcutaneous vagus nerve stimulation (tVNS) and trigeminal transcutaneous electric nerve stimulation (TENS) could improve dyspnoea management by targeting relevant neural circuits.

We will conduct a feasibility cross-over trial in people with severe COPD and significant exertional dyspnoea referred for pulmonary rehabilitation. Patients will be recruited following the prerehabilitation assessment visit comprising a clinical evaluation and a maximal cardiopulmonary exercise testing on ergocycle. Subsequently, two study visits will be conducted within 2 weeks apart from each other. Eight participants will perform a submaximal constant work rate at 80% workload of the VO₂ max, either with cervical tVNS (n=4) or trigeminal TENS (n=4). In a cross-over design, both patient groups will undergo sham and active treatment of the neuromodulation technique in a randomly assigned order. The main outcome will be feasibility, assessed by the percentage of patients who attend all visits and complete all tests. Secondary outcomes include other feasibility endpoints, the acceptability and suitability of the interventions (including an evaluation of sham as an exploratory outcome), and the incidence of adverse or undesirable events related to the procedures. Exploratory outcomes include changes in dyspnoea symptoms, measured using standardised questionnaires, such as Borg scale and the Visual Analogue Scale.

The protocol is approved by the institutional research ethics committee of the Centre intégré universitaire de santé et de services sociaux (CIUSSS) de l’Estrie—CHUS, Sherbrooke, Quebec, Canada (#2025-5604) and follows 2013 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines. Results will be communicated in international meetings and submitted to peer-reviewed journals with respect to the 2010 CONsolidated Standards Of Reporting Trials (CONSORT) statement for feasibility studies.

NCT06985628.