NCT06841341

Electrophysiology and Ultrasound of Respiratory Muscles and Respective Nerves to Predict Respiratory Insufficiency in ALS

ENROLLING BY INVITATION Last updated 15 September 2025

What this trial tests

trial testing electromyography in Amyotrophic Lateral Sclerosis in 80 participants. Enrolling by invitation.

Timeline

8 September 2025

Primary endpoint
31 December 2028

30 June 2029

Quick facts

Lead sponsor	Jagiellonian University
Status	ENROLLING BY INVITATION
Study type	OBSERVATIONAL
Enrollment	80
Start date	8 September 2025
Primary completion	31 December 2028
Estimated completion	30 June 2029
Sites	1 location across Poland

Drugs / interventions tested

• electromyography
• ultrasonography
• Arterial blood gas analysis
• slow vital capacity

Conditions studied

• Amyotrophic Lateral Sclerosis — all drugs for Amyotrophic Lateral Sclerosis →

Sponsor

Jagiellonian University

Who can join

Adults 18 to 80, any sex, with Amyotrophic Lateral Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Respiratory insufficiency is a common complication in amyotrophic lateral sclerosis (ALS). Survival can be prolonged with noninvasive ventilation (NIV). The goal of this study is to assess the value of electromyography of respiratory muscles as well as the ultrasound of the diaphragm and nerves involved in respiration in predicting the onset of respiratory insufficiency, which may improve the timing of NIV start. The study will recruit 80 patients with definite or probable ALS. Investigations include electromyography of bilateral sternocleidomastoideus and rectus abdominis with assessment of presence of acute and chronic denervation. Ultrasonographic measurements include crosssectional area and diameter of bilateral phrenicus, vagus and accesory nerves as well as diameter of diaphragm. Respiratory insufficiency is asessed with slow vital capacity and partial pressure of arterial oxygen and arterial carbon dioxide. Forthermore, ALS severity is assessed with revised ALS Functional Rating Scale and the symptoms which may reflect respiratory insufficiency even in the absence of dyspnea such as sleepiness, fatigue and depression are assessed with Fatigue Severity Scale, Epworth Sleepiness Scale and Hamilton Depression Rating Scale respectively. SVC and blood gases will be compared between group with and without denervation in investigated muscles. SVC and blood gases will be correlated with corssectional areas and diameters of investigated nerves and diaphragm as well as with the scores obtained in used scales and questionnaires.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.