NCT06339632

Effects of Transcutaneous Electrical Phrenic Nerve Stimulation and Transcutaneous Electrical Diaphragmatic Stimulation

Effects of Transcutaneous Electrical Phrenic Nerve Stimulation and Transcutaneous Electrical Diaphragmatic Stimulation: a Randomized Controlled Crossover Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Hospital Sirio-Libanes · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Diaphragm

Interventions

Type	Name	Description
OTHER	Transcutaneous electrical phrenic nerve stimulation (TEPNS)	The characteristics of the electrical current: biphasic waves, set at a stimulation frequency of 10 Hz, pulse width of 200 μs, rise time of 1.0 second, on time of 1.0 second, fall time of 1.0 second, and off time of 2 seconds, resulting in 12 stimuli per minute. The application of "TEPNS" will initially be performed by defining the trajectory of the phrenic nerve in the cervical region. The negative pole (active point), a stick with a spherical tip for micro-current of 2 mm will be positioned with slight pressure in the region of the phrenic nerve pathway between the two heads of the sternocleidomastoid muscle. Additionally, at the positive pole (passive point), a self-adhesive electrode sized (2.0 x 2.0 cm) will be positioned on the skin in the shoulder region. The intensity, measured in milliamperes (mA), will be adjusted to the maximum tolerated by the patient. The total stimulation time will be 10 minutes, applied continuously in a single session.
OTHER	Transcutaneous electrical diaphragm stimulation (TEDS)	The characteristics of the electrical current are: biphasic waves, set at a stimulation frequency of 30 Hz, pulse width of 400 μs, rise time of 1.0 second, on time of 1.0 second, fall time of 1.0 second, and off time of 2 seconds, resulting in 12 stimuli per minute. Two self-adhesive electrodes sized (5.0 x 5.0 cm) will be used, positioned in the bilateral parasternal region next to the xiphoid process and the other electrode in the intercostal space between the 6th and 7th ribs bilaterally, at the mid-axillary line. The intensity, measured in milliamperes (mA), will be adjusted to the maximum intensity tolerated by the patient until diaphragmatic contraction is observed with the naked eye, without contraction of other muscles in the abdominal region. The total stimulation time will be 10 minutes, applied continuously in a single session.

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-12-28
• Completion: 2026-03-01
• First posted: 2024-04-01
• Last updated: 2025-04-24

Locations

1 site across 1 country: Brazil