Status:
RECRUITING
Alleviating Dyspnea With Non-Invasive Neuromodulation
Lead Sponsor:
Université de Sherbrooke
Collaborating Sponsors:
Association Pulmonaire du Quebec
Fonds de la Recherche en Santé du Québec
Conditions:
Dyspnea
Chronic Obstructive Pulmonary Disease Severe
Eligibility:
All Genders
40-85 years
Phase:
NA
Brief 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 (tVN...
Detailed Description
Objectives Primary objective: \- To assess the feasibility of studying non-invasive neuromodulation techniques, specifically cervical transcutaneous vagal nerve stimulation (tVNS) and trigeminal tra...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT06985628
Start Date
November 18 2024
End Date
December 1 2025
Last Update
May 22 2025
Active Locations (1)
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1
Centre hospitalier universitaire de Sherbrooke (CHUS)
Sherbrooke, Quebec, Canada, J1H 5H3