Alleviating Dyspnea With Non-Invasive Neuromodulation : A Feasibility Sham-Controlled Randomized Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
Centre hospitalier universitaire de Sherbrooke (CHUS)
RECRUITING
Sherbrooke
Contact Information
Primary
Simon Couillard, MD MSc
s.couillard@usherbrooke.ca
819-346-1110
Backup
Martine Duval, PhD
martine.duval@usherbrooke.ca
819-821-8000
Time Frame
Start Date: 2024-11-18
Estimated Completion Date: 2025-12
Participants
Target number of participants: 8
Treatments
Experimental: tVNS
Two options of schedule (according to crossover randomization):~\- VNSsa : Visit 1 : sham → Visit 2 : active tVNS~\- VNSac : Visit 1 : active tVNS → Visit 2 : sham
Experimental: Trigeminal TENS
Two options of schedule (according to crossover randomization):~\- TENSsa : Visit 1 : sham → Visit 2 : active trigeminal TENS~\- TENSac : Visit 1 : active trigeminal TENS → Visit 2 : sham
Sponsors
Collaborators: Fonds de la Recherche en Santé du Québec, Québec Air-Intersectorialité-Respiratoire-Son network, Association Pulmonaire du Quebec
Leads: Université de Sherbrooke

This content was sourced from clinicaltrials.gov