Non-Invasive Neuromodulation for Chronic Obstructive Pulmonary Disease

(PNEURO Trial)

Overseen By Martine Duval, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Université de Sherbrooke

Must not be taking: Corticosteroids, Antibiotics

Disqualifiers: Pulmonary restrictive, Neurological disorders, Cardiac instabilities, Metal implants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

8 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Simon Couillard, MD MSc

Principal Investigator

Université de Sherbrooke

Joël St-Pierre, MD MSc candidate

Principal Investigator

Université de Sherbrooke

Christian Iorio-Morin, MD PhD

Principal Investigator

Université de Sherbrooke

Eligibility Criteria

This trial is for patients with chronic obstructive pulmonary disease (COPD) who experience severe shortness of breath. Participants must be able to undergo cardiopulmonary exercise testing and other routine assessments like spirometry.

Inclusion Criteria

I have had severe shortness of breath for at least 6 months.

Physical capability to undergo submaximal constant work rate (CRW)

I have been referred for lung rehab.

Exclusion Criteria

I have a lung condition that restricts my breathing.

I have a neurological condition like epilepsy or Parkinson's.

Pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo a baseline maximal Cardiopulmonary Exercise Testing (CPET) and other assessments to establish initial conditions

1 week

1 visit (in-person)

Treatment

Participants receive either cervical tVNS or trigeminal TENS, with a crossover design involving sham and active treatments

4 weeks

2 visits (in-person, 2 weeks apart)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

Treatment Details

Interventions

• Transcutaneous electrical nerve stimulation (TENS)
• Transcutaneous vagal nerve stimulation (tVNS)

Trial Overview The study tests if non-invasive neuromodulation techniques, specifically transcutaneous vagal nerve stimulation (tVNS) and transcutaneous electrical nerve stimulation (TENS), can alleviate dyspnea in COPD patients compared to a sham treatment.

Participant Groups

Group I: tVNS Experimental Treatment 1 Intervention

Two options of schedule (according to crossover randomization): - VNSsa : Visit 1 : sham → Visit 2 : active tVNS - VNSac : Visit 1 : active tVNS → Visit 2 : sham

Group II: Trigeminal TENS Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Université de Sherbrooke

Lead Sponsor

Trials

317

Recruited

79,300+

Fonds de la Recherche en Santé du Québec

Collaborator

Trials

84

Recruited

46,700+

Association pulmonaire du Québec

Collaborator

Trials

2

Recruited

200+

Québec Air-Intersectorialité-Respiratoire-Son network

Collaborator

Association Pulmonaire du Quebec

Collaborator