{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,8,2]],"date-time":"2025-08-02T16:51:25Z","timestamp":1754153485301,"version":"3.41.2"},"reference-count":64,"publisher":"BMJ","issue":"7","license":[{"start":{"date-parts":[[2025,7,23]],"date-time":"2025-07-23T00:00:00Z","timestamp":1753228800000},"content-version":"unspecified","delay-in-days":22,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100020870","name":"Facult\u00e9 de m\u00e9decine et des sciences de la sant\u00e9, Universit\u00e9 de Sherbrooke","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100020870","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Qu\u00e9bec Air-Intersectorialit\u00e9-Respiratoire-Son Network"},{"DOI":"10.13039\/501100000156","name":"Fonds de Recherche du Qu\u00e9bec - Sant\u00e9","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100000156","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Association Pulmonaire du Qu\u00e9bec"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,7,7]]},"published-print":{"date-parts":[[2025,7]]},"abstract":"<jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and analysis<\/jats:title>\n                  <jats:p>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 VO<jats:sub>2<\/jats:sub> 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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Ethics and dissemination<\/jats:title>\n                  <jats:p>The protocol is approved by the institutional research ethics committee of the <jats:italic>Centre int\u00e9gr\u00e9 universitaire de sant\u00e9 et de services sociaux (CIUSSS) de l\u2019Estrie<\/jats:italic>\u2014CHUS, Sherbrooke, Quebec, Canada (#2025-5604) and follows <jats:italic>2013 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)<\/jats:italic> guidelines. Results will be communicated in international meetings and submitted to peer-reviewed journals with respect to the <jats:italic>2010 CONsolidated Standards Of Reporting Trials (CONSORT)<\/jats:italic> statement for feasibility studies.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>\n                     <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT06985628\">NCT06985628<\/jats:ext-link>.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-103891","type":"journal-article","created":{"date-parts":[[2025,7,23]],"date-time":"2025-07-23T04:10:59Z","timestamp":1753243859000},"page":"e103891","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Non-invasive neuromodulation for alleviating dyspnoea: protocol for a feasibility sham-controlled randomised trial"],"prefix":"10.1136","volume":"15","clinical-trial-number":[{"clinical-trial-number":"nct06985628","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Jo\u00ebl","family":"St-Pierre","sequence":"first","affiliation":[{"name":"Facult\u00e9 de M\u00e9decine et des Sciences de la Sant\u00e9, Universit\u00e9 de Sherbrooke, Sherbrooke, Quebec, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Samuel","family":"Mailhot-Larouche","sequence":"additional","affiliation":[{"name":"Facult\u00e9 de M\u00e9decine et des Sciences de la Sant\u00e9, Universit\u00e9 de Sherbrooke, Sherbrooke, Quebec, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Genevi\u00e8ve","family":"Garand","sequence":"additional","affiliation":[{"name":"Centre de Recherche du CHUS, Sherbrooke, Quebec, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"F\u00e9lix-Antoine","family":"V\u00e9zina","sequence":"additional","affiliation":[{"name":"Facult\u00e9 de M\u00e9decine et des Sciences de la Sant\u00e9, Universit\u00e9 de Sherbrooke, Sherbrooke, Quebec, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Guillaume","family":"L\u00e9onard","sequence":"additional","affiliation":[{"name":"Facult\u00e9 de M\u00e9decine et des Sciences de la Sant\u00e9, Universit\u00e9 de Sherbrooke, Sherbrooke, Quebec, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christian","family":"Iorio-Morin","sequence":"additional","affiliation":[{"name":"Facult\u00e9 de M\u00e9decine et des Sciences de la Sant\u00e9, Universit\u00e9 de Sherbrooke, Sherbrooke, Quebec, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4057-6886","authenticated-orcid":false,"given":"Simon","family":"Couillard","sequence":"additional","affiliation":[{"name":"Facult\u00e9 de M\u00e9decine et des Sciences de la Sant\u00e9, Universit\u00e9 de Sherbrooke, Sherbrooke, Quebec, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2025,7,22]]},"reference":[{"key":"2025072221103983000_15.7.e103891.1","unstructured":"Hashmi MF , Modi P , Basit H , et al . 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