Alleviating Dyspnea With Non-Invasive Neuromodulation : A Feasibility Sham-Controlled Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Sample study completion proportion
研究概览
简要总结
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.
详细描述
Objectives
Primary objective:
- To assess the feasibility of studying non-invasive neuromodulation techniques, specifically cervical transcutaneous vagal nerve stimulation (tVNS) and trigeminal transcutaneous electrical nerve stimulation (TENS) of the trigeminal nerve to alleviate dyspnea in patients with severe chronic pulmonary disease.
Exploratory objectives:
- To evaluate alterations in dyspnea perception resulting from the interventions.
- To review the involvement of trigeminal and vagal nerves in the neurological pathways of dyspnea, as documented in existing scientific literature.
- To evaluate the convenience of VNS and TENS devices and of their use on the patients with chronic pulmonary diseases.
- To assess the quality of the sham employed in this trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
This study employs a single-blinded format, where participants are unaware if they are receiving the sham or the real interventions, but the researchers in charge of data collection or of the analysis are not blinded.
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Transcutaneous vagal nerve stimulation (tVNS) (Device)
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
干预措施: Transcutaneous electrical nerve stimulation (TENS) (Device)
结局指标
主要结局
Sample study completion proportion
时间窗: At every visit until the visit 2 (at week 2)
Percentage of recruited patients attending all visits and completing all tests
次要结局
- Occurrence of any adverse effects and undesirable events(At every visit until the visit 2 (at week 2))
- Adverse effects and undesirable events regarding the study procedures (exercise testing and interventions)(At every visit until the visit 2 (at week 2))
- General acceptability of the study procedures (exercise testing and interventions)(At the end of the visit 2 (at week 2))
- Recruitment results(At the visit 1 (at week 0))
- Change from baseline for each intervention (tVNS and trigeminal TENS)(At every visit until the visit 2 (at week 2))
- Absolute change in pedaling time at the same pace from baseline(At every visit until the visit 2 (at week 2))
- Sham evaluation(At the end of the visit 2 (at week 2))
研究者
Simon Couillard
M.D. M.Sc., Assistant-professor in medicine, Respirology Service, Department of Medicine
Université de Sherbrooke