Zapping nerves to breathe easier: tiny trial tests new COPD approach

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Severe COPD (between FEV1 20-50%, FEV1/FVC \< 0.7, and smoking history of ≥ 10 pack-years, 3rd-4th grade on the dyspnea scale modified Medical Research Council (mMRC), COPD Assessment Test (CAT) score ≥ 10) * Significant chronic dyspnea for at least 6 months * Referred for pulmonary rehabilitation * Physical capability to undergo submaximal constant work rate (CRW) * Ability to comprehend the implications of the procedures and follow-up visits and provide free informed consent Exclusion Criteria: * Presence of concurrent pulmonary restrictive features * Neurological disorders susceptible to be influenced by neurostimulation procedures, including epilepsy, Parkinson's disease, trigeminal neuralgia, dysautonomia, and vagal disorders * Unstable arrhythmias, and other cardiac instabilities * Patients with cardiac pacemakers, defibrillators, or other metal implants * Patients who have undergone pulmonary resection resulting in the absence of pulmonary lobe(s) or complete lung * Other serious dyspneic conditions, such as anemia, heart failure with decreased ejection fraction, or mitochondrial dysfunction * Pregnancy * Active infections * Known reactions or intolerance to tVNS or trigeminal TENS Patients must have no moderate-to-severe exacerbations (defined as an increase in symptoms for more than 3 days requiring corticosteroids or antibiotics, or hospitalisation) for at least one month before the baseline visit and at least one month before the first experimental visit (W0 visit). Participants that were randomized yet experience an exacerbation between the first (at week 0) and second (at week 2) experimental visits will be removed from the trial. \*Abbreviations : COPD : chronic obstructive pulmonary disease FEV1 : Forced Expiratory Volume in one second FVC : Forced vital capacity tVNS : Transcutaneous vagal nerve stimulation TENS : Transcutaneous electrical nerve stimulation