Alleviating Dyspnea With Non-Invasive Neuromodulation

Summary

The goal of this feasibility sham-controlled randomized trial is to assess the feasibility of studying non-invasive neuromodulation techniques, specifically transcutaneous vagal nerve stimulation (tVNS) and transcutaneous electrical nerve stimulation (TENS) of the trigeminal nerve to alleviate dyspnea in patients with chronic pulmonary disease. The main question it aims to answer is: Despite challenges in dyspnea generation and measurement, could non-invasive neuromodulation be reliably studied in chronic obstructive pulmonary disease (COPD) with severe dyspnea? Researchers will compare tVNS and trigeminal TENS to a sham (where the device is applied, but without stimulation) in order to see if non-invasive neuromodulation could relieve dyspnea. At the time of rehabilitation pre-assessment, participants routinely undergo a baseline maximal Cardiopulmonary Exercise Testing (CPET) on ergocycle to measure VO2max with repetitive assessments of the Borg scale and continuous monitoring of vital signs (oxygen saturation, heart rate, blood pressure, respiratory rate) throughout the test. Spirometry and symptom questionnaires (CAT score) are also routinely measured. In two dedicated study visits conducted 2 weeks apart from each other, n=8 participants will perform a submaximal constant workrate (CRW) 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 number.

Eligibility

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

Conditions3

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