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.

Conditions

• Dyspnea
• Chronic Obstructive Pulmonary Disease Severe

Interventions

DEVICE

Transcutaneous vagal nerve stimulation (tVNS)

tVNS will be applied at the cervical level of the vagal nerve.

DEVICE

Transcutaneous electrical nerve stimulation (TENS)

TENS will be applied facially on the trigeminal nerve.

Sponsors & Collaborators

• Association Pulmonaire du Quebec

  collaborator OTHER

• Fonds de la Recherche en Santé du Québec

  collaborator OTHER_GOV

• Québec Air-Intersectorialité-Respiratoire-Son network

  collaborator UNKNOWN

• Université de Sherbrooke

  lead OTHER

Principal Investigators

• Joël St-Pierre, MD MSc candidate · Université de Sherbrooke

• Simon Couillard, MD MSc · Université de Sherbrooke

• Christian Iorio-Morin, MD PhD · Université de Sherbrooke

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

40 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-18

Primary Completion

2025-12-10

Completion

2025-12-10

FDA Device

Yes

Countries

• Canada

Study Locations