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Clinical Trial Summary

Transcutaneous electrical phrenic nerve stimulation (TEPNS) and transcutaneous electrical diaphragm stimulation (TEDS) are modalities that use surface electrodes placed on the patients' skin to generate action potentials and contractions of the muscle fibers of the diaphragm. The primary objective will be to evaluate the efficacy of TEPNS and TEDS in healthy adult individuals. Secondary objectives will be to assess the feasibility, safety, and level of discomfort reported by the individual resulting from the application of TEPNS and TEDS.


Clinical Trial Description

This crossover trial, single-blind, bicentric study will be conducted at two hospitals. Adult volunteers aged 18 to 60 years, healthy, with a body mass index between 18.5 and 24.9 kg/m2, without a history of previous respiratory diseases, and without contraindications to undergo evaluation or application of the proposed electrical stimulation modalities will be included. Participants' diaphragm muscle will be assessed using ultrasound for variables such as thickness, thickness fraction, and diaphragm mobility. Patients will be randomized using opaque envelope draw prior to evaluation into two distinct experimental moments: 1) "TEPNS" moment - application of the TEPNS protocol; or 2) "TEDS" moment - application of the TEDS protocol. Additionally, data regarding the feasibility and safety of the application of electrical stimulation modalities will be collected. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06339632
Study type Interventional
Source Hospital Sirio-Libanes
Contact RENATO F RIGHETTI, PhD
Phone 11987496664
Email refragar@gmail.com
Status Recruiting
Phase N/A
Start date April 1, 2024
Completion date March 1, 2025

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