NCT04884698

"Electromagnetical Stimulation of Phrenic Nerve to Generate Contraction of the Diaphragm"

Completed NA Last updated 6 January 2022

What this trial tests

NA trial testing Stimit Activator in Healthy Subjects in 10 participants. Completed in 13 December 2021.

Timeline

25 June 2021

Primary endpoint
13 December 2021

13 December 2021

Quick facts

Lead sponsor	Stimit AG
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	10
Start date	25 June 2021
Primary completion	13 December 2021
Estimated completion	13 December 2021
Sites	1 location across Switzerland

Drugs / interventions tested

• Stimit Activator

Conditions studied

• Healthy Subjects — all drugs for Healthy Subjects →
• Elective Surgical Procedure — all drugs for Elective Surgical Procedure →

Sponsor

Stimit AG

Who can join

18 and older, any sex, with Healthy Subjects or Elective Surgical Procedure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The scientific study is intended to show that external non-invasive electromagnetic stimulation can be used to safely and effectively stimulate the phrenic nerve in awake healthy subjects as well as in ventilated, anesthetized patients and that the stimulation can generate a diaphragmatic contraction that generates significant breath volume - a Controlled Own Breath (COB).

Also of interest is the reproducibility of the generated diaphragmatic movements and the reliability of different feedback signals for detecting the generated diaphragmatic contraction. This applies to inspiration and expiration detection for subsequent synchronization mechanisms of the magnetic stimulator for patient-initiated breathing as well as to contraction intensity. Further, the characterization of the position finding process is of great importance, so that technical developments can further simplify the process of coil positioning in the future. The possible occurrence of discomfort and pain sensation will also be investigated in awake healthy volunteers. Different stimulation protocols will be used.

Finally, it will be investigated whether an adjusted coil position still triggers reproducible diaphragmatic contractions after removal and repositioning in the same configuration. The knowledge gained will be used to further develop the technique and to prepare a study in critically ill, ventilated patients where the diaphragmatic muscle is to be treated preventively by stimulating the phrenic nerve, in order to prevent atrophy of the muscle.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Safety and Feasibility of Noninvasive Electromagnetic Stimulation of the Phrenic Nerves.
   Mueller G, Aszalos E, Krause S, Niederhauser T, et al · · 2023 · cited 9× · PMID 36878642 · DOI 10.4187/respcare.10568