Non-invasive neuromodulation for alleviating dyspnoea: protocol for a feasibility sham-controlled randomised trial

Area of Science:

• Neurology
• Pulmonology
• Rehabilitation Medicine

Background:

• Dyspnoea is a prevalent and distressing symptom in 10% of the general population and 12% of hospitalized patients, particularly those with Chronic Obstructive Pulmonary Disease (COPD).
• Neuromodulation, utilizing electrical stimulation to modulate neural pathways, presents a validated therapeutic approach for various conditions.
• Non-invasive neuromodulation techniques, specifically transcutaneous vagus nerve stimulation (tVNS) and trigeminal transcutaneous electric nerve stimulation (TENS), are hypothesized to improve dyspnoea management by targeting relevant neural circuits.

Purpose of the Study:

• To assess the feasibility of conducting a cross-over trial investigating the efficacy of tVNS and TENS in managing dyspnoea in severe COPD patients.
• To evaluate the acceptability, suitability, and safety of tVNS and TENS interventions in this patient population.
• To explore the impact of these neuromodulation techniques on dyspnoea symptoms as a secondary objective.

Main Methods:

• A feasibility cross-over trial involving individuals with severe COPD and significant exertional dyspnoea undergoing pulmonary rehabilitation.
• Participants will undergo maximal cardiopulmonary exercise testing and then engage in submaximal constant work rate exercise (80% VO2 max) with either cervical tVNS or trigeminal TENS.
• A randomized, cross-over design will be employed, with each participant receiving both active and sham treatments for the assigned neuromodulation technique, separated by a washout period.

Main Results:

• Feasibility will be the primary outcome, measured by patient attendance and completion rates for all study visits and tests.
• Secondary feasibility outcomes include intervention acceptability, suitability, and the incidence of adverse events.
• Exploratory outcomes will involve assessing changes in dyspnoea severity using validated questionnaires like the Borg scale and Visual Analogue Scale.

Conclusions:

• This study will provide crucial feasibility data for a novel neuromodulation approach to dyspnoea management in COPD patients.
• Findings will inform the design of larger, definitive trials investigating the therapeutic potential of tVNS and TENS for respiratory symptoms.
• The research will contribute to understanding the safety and patient-reported outcomes associated with these non-invasive neuromodulation techniques.