Effects of electrical stimulation on diaphragm function
Effects of Transcutaneous Electrical Phrenic Nerve Stimulation and Transcutaneous Electrical Diaphragmatic Stimulation: a Randomized Controlled Crossover Trial
This study is testing if two types of electrical stimulation can improve diaphragm function in healthy adults aged 18 to 60.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Hospital Sirio-Libanes Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT06339632 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy of transcutaneous electrical phrenic nerve stimulation (TEPNS) and transcutaneous electrical diaphragm stimulation (TEDS) in healthy adults. Participants aged 18 to 60 with a normal BMI will undergo a crossover design where they will receive both TEPNS and TEDS interventions. The diaphragm's muscle characteristics will be assessed using ultrasound, and the study will also gather data on the feasibility, safety, and discomfort associated with these stimulation techniques. The trial is conducted at two hospitals in a single-blind format.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 to 60 with a normal BMI and no history of respiratory diseases.
Not a fit: Patients with pre-existing cardiopulmonary diseases or those with implanted electrical devices will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance diaphragm function and improve respiratory therapies.
How similar studies have performed: While the approach is innovative, similar studies have shown promise in using electrical stimulation for muscle function enhancement.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 60 years; * Normal pulmonary function test, without alterations, assessed through spirometry; * Body Mass Index (BMI) between 18.5 and 24.9 kg/m2. Exclusion Criteria: * Smokers or former smokers; * Individuals with previously known cardiopulmonary diseases (restrictive lung diseases, chronic obstructive pulmonary disease - COPD, asthma, cystic fibrosis, among other pathologies); * Presence of implanted electrical devices (pacemaker, implantable cardioverter-defibrillator, among others); * Individuals who have contraindications to undergo evaluation and/or application of transcutaneous electrical stimulation of the diaphragm muscle, such as: altered sensitivity, wounds at the site of application, deformities, among other conditions.
Where this trial is running
São Paulo, São Paulo
- Hospital Sírio Libanês — São Paulo, São Paulo, Brazil (Recruiting)
Study contacts
- Study coordinator: RENATO F RIGHETTI, PhD
- Email: refragar@gmail.com
- Phone: 11987496664
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.