Alleviating Dyspnea With Non-Invasive Neuromodulation

Launched by UNIVERSITÉ DE SHERBROOKE · May 14, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring new ways to help people with severe chronic obstructive pulmonary disease (COPD) manage their breathlessness, a condition known as dyspnea. Researchers want to see if non-invasive techniques like transcutaneous vagal nerve stimulation (tVNS) and transcutaneous electrical nerve stimulation (TENS) can effectively reduce this uncomfortable feeling. To find out, they will compare the effects of these treatments against a “sham” treatment, where the device is applied but does not actually stimulate the nerves. The goal is to determine if these methods can be reliably studied and potentially help patients breathe easier.

To be eligible for the trial, participants must have severe COPD and experience significant breathlessness for at least six months. They should also be referred for pulmonary rehabilitation and able to participate in exercise testing. During the study, participants will undergo two visits spaced two weeks apart, where they will engage in a controlled exercise test using either tVNS or TENS, with some sessions involving a sham treatment. It's important to note that individuals with certain health issues, like neurological disorders or serious heart conditions, will not be able to participate. Overall, this trial aims to provide valuable insights into new treatment options for managing dyspnea in COPD patients.

Gender

ALL

Eligibility criteria

• 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