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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if gentle electrical nerve stimulation can help individuals with severe chronic obstructive pulmonary disease (COPD) breathe more easily. Researchers are testing two non-invasive treatments: one targets the vagal nerve in the neck (transcutaneous vagal nerve stimulation, or tVNS), and the other targets the trigeminal nerve in the face (transcutaneous electrical nerve stimulation, or TENS). Participants will experience both the real treatment and a sham version (without actual stimulation) to assess whether either method effectively reduces breathing difficulty. This trial is designed for individuals who have experienced significant breathing problems for at least six months and are undergoing pulmonary rehabilitation. As an unphased trial, it offers a unique opportunity to explore innovative treatments that could enhance quality of life.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it does mention that participants should not have moderate-to-severe exacerbations requiring corticosteroids or antibiotics for at least one month before the trial. It's best to discuss your current medications with the trial team.

What prior data suggests that these non-invasive neuromodulation techniques are safe for COPD patients?

Earlier studies have primarily examined transcutaneous vagal nerve stimulation (tVNS) for epilepsy and depression. The FDA has approved it for these conditions, indicating its safety for nerve stimulation. However, its use for other issues, such as breathing problems, remains under investigation.

Similarly, transcutaneous electrical nerve stimulation (TENS) has shown promise in improving breathing for people with COPD, with few reported side effects. Research suggests it might be safe and could help reduce symptoms like breathlessness.

Both treatments stimulate nerves through the skin to alleviate symptoms. They appear well-tolerated so far, but more research is needed to fully understand their safety for COPD. Always consult a healthcare provider before considering participation in a study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for chronic obstructive pulmonary disease (COPD), which often include medications like bronchodilators and corticosteroids, these new approaches focus on non-invasive neuromodulation. Transcutaneous vagal nerve stimulation (tVNS) and transcutaneous electrical nerve stimulation (TENS) are unique because they work by stimulating nerves to potentially improve lung function and reduce symptoms without the need for drugs. Researchers are excited about these treatments because they offer a new, drug-free method that might provide relief with fewer side effects. This innovative approach could be a game-changer for those who struggle with the side effects or limited effectiveness of current COPD treatments.

What evidence suggests that non-invasive neuromodulation could be effective for chronic obstructive pulmonary disease?

This trial will compare the effects of transcutaneous vagal nerve stimulation (tVNS) and transcutaneous electrical nerve stimulation (TENS) on chronic obstructive pulmonary disease (COPD). Studies have shown that tVNS can improve heart and lung fitness and may help with breathing issues. One study found that tVNS significantly improved lung function, with a 59.94% increase in FEV1, a measure of lung capacity, shortly after treatment. For TENS, evidence suggests it can enhance lung function and overall health in people with COPD. Research indicates that TENS can improve daily activity performance, likely by helping to open up the airways. Both tVNS and TENS show promise for addressing breathing problems in COPD. ^{1 2 6 7 8}

Who Is on the Research Team?

Joël St-Pierre, MD MSc candidate

Principal Investigator

Université de Sherbrooke

Simon Couillard, MD MSc

Principal Investigator

Université de Sherbrooke

Christian Iorio-Morin, MD PhD

Principal Investigator

Université de Sherbrooke

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9583392/

Transcutaneous electrical nerve stimulation over acupoint for ... Acu-TENS seems to be effective in improving pulmonary function and health status in patients with COPD, with little effect on exercise capacity and dyspnea.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT00971490

Effects of a 4-week Acu-Transcutaneous Electrical Nerve ... The objectives of this study are to investigate the effectiveness of Acu-TENS (transcutaneous electrical nerve stimulation applied on acupoints) on lung ...

3. journals.lww.com journals.lww.com/md-journal/fulltext/2018/06220/transcutaneous_electric_nerve_stimulation_over.74.aspx

Transcutaneous electric nerve stimulation over acupoints... There is a limited evidence concerning the efficacy of transcutaneous electric nerve stimulation over acupoints (Acu-TENS) for chronic obstructive pulmonary ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27325551/

The effect of transcutaneous electrical nerve stimulation in ... Background: In patients with stable chronic obstructive pulmonary disease, transcutaneous electrical nerve stimulation has been known to attain improvement ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1569904810002235

Effect of 4 weeks of Acu-TENS on functional capacity and β ... To conclude, 4 weeks of Acu-TENS improved the functional capacity of patients with COPD, probably due to the bronchodilation induced by β-endorphin elevation.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/21607562/

Feasibility of transcutaneous electrical muscle stimulation ... This study investigated feasibility and safety of this method during acute exacerbation of chronic obstructive pulmonary disease. We included 19 patients ...

7. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3757-x

Acupoint transcutaneous electrical nerve stimulation in ... - Trials This study aims to determine whether the administration of acuTENS can reduce dyspnoea in patients hospitalized for AECOPD.

8. sciencedirect.com sciencedirect.com/science/article/pii/S095461111300499X

Neuromuscular electrical stimulation improves clinical and ... Neuromuscular electrical stimulation (NMES) improves muscle performance and exercise tolerance in chronic obstructive pulmonary disease (COPD) patients.