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

NCT06339632 | Recruiting DMC

• 1 other identifier: AVAP-NG 3363
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diaphragm

Keywords

Diaphragm; Transcutaneous electrical nerve stimulation; Ultrasound

Outcome Measures

Primary Outcomes (3)

• Diaphragm mobility

  The assessment of diaphragmatic mobility will use a "convex" type transducer (2-6 MHz), positioned in the right subcostal space, at the midclavicular line, tilted in the cephalic direction. The B-mode visualization window will initially be used to locate the diaphragmatic hemi-dome. Upon acquiring a good quality image, respiratory excursions will be measured in M-mode, using the inferior vena cava and the gallbladder as anatomical parameters. Diaphragmatic mobility measurement will be considered as the distance, in centimeters, between the baseline at expiration and its greatest vertical displacement at inspiration produced by diaphragmatic movement.

  At baseline, between the fourth and fifth minutes and between the ninth and tenth minutes after the start of stimulation.

• Diaphragm thickness

  Diaphragm thickness (Tdi) will be obtained using a high-frequency "linear" type transducer (7-13 MHz), positioned over the zone of apposition (ZA) of the diaphragm muscle. The approximate location is between the 8th and 9th intercostal space, between the anterior axillary line and the midaxillary line, 0.5 to 2.0 cm below the costophrenic angle. The depth will be 1.5 to 3.0 cm, and the diaphragm muscle will be identified as the innermost portion of the hypoechoic muscular layer bounded by two hyperechoic membranes, the pleura - superficial line, and the peritoneum - deeper line. "Tdi" will be measured from the inner edge of the pleural line to the inner edge of the peritoneal line at the end of expiration (Tdi-exp); and at the end of inspiration (Tdi-insp).

  At baseline, between the fourth and fifth minutes and between the ninth and tenth minutes after the start of stimulation.

• Thickening fraction

  The thickening fraction will be obtained using a high-frequency "linear" type transducer (7-13 MHz), positioned over the zone of apposition (ZA) of the diaphragm muscle. The approximate location is between the 8th and 9th intercostal space, between the anterior axillary line and the midaxillary line, 0.5 to 2.0 cm below the costophrenic angle. The depth will be 1.5 to 3.0 cm, and the diaphragm muscle will be identified as the innermost portion of the hypoechoic muscular layer bounded by two hyperechoic membranes, the pleura - superficial line, and the peritoneum - deeper line. The localization of structures and measurements will be performed in B-mode. The diaphragm thickening fraction will be calculated as the percentage of thickness increment during inspiration relative to the thickness at the end of expiration.

  At baseline, between the fourth and fifth minutes and between the ninth and tenth minutes after the start of stimulation.

Secondary Outcomes (2)

• Evaluation of sensory discomfort

  At baseline, five and 10 minutes the start of stimulation.

• Safety of TEPNS and TEDS application

  The events will be monitored throughout the entire period of TEPNS and TEDS application.

Study Arms (2)

Transcutaneous electrical phrenic nerve stimulation (TEPNS)

EXPERIMENTAL

The technique will be performed by applying transcutaneous neuromuscular electrical stimulation to the phrenic nerve pathway in the cervical region.

Other: Transcutaneous electrical phrenic nerve stimulation (TEPNS)

Transcutaneous electrical diaphragm stimulation (TEDS)

ACTIVE COMPARATOR

The technique will be performed by applying transcutaneous neuromuscular electrical stimulation with the electrodes positioned bilaterally in the parasternal region adjacent to the xiphoid process, and the other electrode placed in the intercostal space.

Other: Transcutaneous electrical diaphragm stimulation (TEDS)

Interventions

Transcutaneous electrical phrenic nerve stimulation (TEPNS) OTHER

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.

Transcutaneous electrical phrenic nerve stimulation (TEPNS)

Transcutaneous electrical diaphragm stimulation (TEDS) OTHER

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.

Transcutaneous electrical diaphragm stimulation (TEDS)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Sirio-Libanes: lead
• Hospital Israelita Albert Einstein: collaborator

Study Sites (1)

Hospital Sírio Libanês

São Paulo, São Paulo, 01308-050, Brazil

RECRUITING

Related Publications (7)

• Boon AJ, Harper CJ, Ghahfarokhi LS, Strommen JA, Watson JC, Sorenson EJ. Two-dimensional ultrasound imaging of the diaphragm: quantitative values in normal subjects. Muscle Nerve. 2013 Jun;47(6):884-9. doi: 10.1002/mus.23702. Epub 2013 Apr 29.

  PMID: 23625789 BACKGROUND

• Cancelliero-Gaiad KM, Ike D, Pantoni CB, Mendes RG, Borghi-Silva A, Costa D. Acute effects of transcutaneous electrical diaphragmatic stimulation on respiratory pattern in COPD patients: cross-sectional and comparative clinical trial. Braz J Phys Ther. 2013 Nov-Dec;17(6):547-55. doi: 10.1590/S1413-35552012005000121. Epub 2013 Nov 14.

  PMID: 24271095 BACKGROUND

• Canella C, Demondion X, Delebarre A, Moraux A, Cotten H, Cotten A. Anatomical study of phrenic nerve using ultrasound. Eur Radiol. 2010 Mar;20(3):659-65. doi: 10.1007/s00330-009-1579-z. Epub 2009 Sep 2.

  PMID: 19727747 BACKGROUND

• Carrillo-Esper R, Perez-Calatayud AA, Arch-Tirado E, Diaz-Carrillo MA, Garrido-Aguirre E, Tapia-Velazco R, Pena-Perez CA, Espinoza-de Los Monteros I, Meza-Marquez JM, Flores-Rivera OI, Zepeda-Mendoza AD, de la Torre-Leon T. Standardization of Sonographic Diaphragm Thickness Evaluations in Healthy Volunteers. Respir Care. 2016 Jul;61(7):920-4. doi: 10.4187/respcare.03999. Epub 2016 Apr 12.

  PMID: 27072012 BACKGROUND

• Hedenstierna G, Tokics L, Lundquist H, Andersson T, Strandberg A, Brismar B. Phrenic nerve stimulation during halothane anesthesia. Effects of atelectasis. Anesthesiology. 1994 Apr;80(4):751-60. doi: 10.1097/00000542-199404000-00006.

  PMID: 8024128 BACKGROUND

• Santana PV, Cardenas LZ, Albuquerque ALP, Carvalho CRR, Caruso P. Diaphragmatic ultrasound: a review of its methodological aspects and clinical uses. J Bras Pneumol. 2020 Nov 20;46(6):e20200064. doi: 10.36416/1806-3756/e20200064. eCollection 2020.

  PMID: 33237154 BACKGROUND

• Testa A, Soldati G, Giannuzzi R, Berardi S, Portale G, Gentiloni Silveri N. Ultrasound M-mode assessment of diaphragmatic kinetics by anterior transverse scanning in healthy subjects. Ultrasound Med Biol. 2011 Jan;37(1):44-52. doi: 10.1016/j.ultrasmedbio.2010.10.004.

  PMID: 21144957 BACKGROUND

Central Study Contacts

RENATO F RIGHETTI, PhD

CONTACT

11987496664; refragar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researchers responsible for assessing diaphragm muscle through ultrasound will perform image recordings and captures during the "TEPNS" and "TEDS" intervention moments. Subsequently, the images will be analyzed by a blinded evaluator for the adopted intervention. The analyses will follow the methods described in the "diaphragm muscle mobility" and "diaphragm muscle thickness and thickening fraction" sections. Study participants will also be instructed not to disclose information regarding their experience and sensations during the intervention period, ensuring study blinding.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 1, 2024
• Study Start: April 1, 2024
• Primary Completion: December 28, 2025
• Study Completion: March 1, 2026
• Last Updated: April 24, 2025

Record last verified: 2025-04

Locations

BR (1)