Neurobiological and Immunological Mechanisms of Dyspnea in ALS (BIOPNEA)

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

Neurobiological and Neuro-immunological Mechanisms of Dyspnea in Amyotrophic Lateral Sclerosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04332198
• Other study ID #: 2019_A02882_55
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2023
• Est. completion date: October 2024

Study information

• Verified date: February 2022
• Source: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Dyspnea; subjective experience of respiratory discomfort; which produces negative emotional experience, is the most common symptom of patients afflicted with chronic respiratory failure and its treatments are limited. Amyotrophic Lateral Sclerosis (ALS) related - dyspnea, due to diaphragmatic dysfunction, is similar to dyspnea during mechanical inspiratory load (activation of the supplementary motor area, SMA). The perception of pain and dyspnea is processed in similar brain areas (insula, dorsal anterior cingulate cortex, amygdala and medial thalamus) and in ALS; relieving dyspnea by noninvasive ventilation (NIV) is associated with decreased pain thresholds. Otherwise, it is reported systemic elevations of pro-inflammatory cytokines in chronic pain patients, correlating with intensity of pain, and during respiratory load in healthy volunteers.

The objectives are to evaluate the cytokines and endorphins rates variations after initiation of NIV in ALS patients, and to correlate cytokines and endorphins rates with the intensity of the affective component and the intensity of the sensory component of dyspnea.

The investigators will perform a prospective, experimental study, including 30 ALS patients. Dyspnea, ventilatory and cardiac settings, electromyographic recording of the scalene muscle and biological assays (ACTH, endorphin, Neuropeptide P, BDNF, IL1, IL6, IL8, IL10, TNF), will be measured during spontaneous breathing and during NIV at different times after initiation.

The investigators expect a reduction of immunological and neurobiological markers after relieving dyspnea by NIV. This work could lead to the development of new treatments for dyspnea.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with chronic respiratory failure with diaphragmatic dysfunction linked to amyotrophic lateral sclerosis and requiring long-term NIV

Exclusion Criteria:

• Other respiratory disease (COPD, asthma, obstructive sleep apnea)

• Alcohol or psychotropic drug the lasts 24 hours

• Cognitive impairment

• Smoking > 10 PA

• Exacerbation or infection 6 weeks earlier

• Endstage of illness

• Chronic or acute pain (VAS > 3)

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Dyspnea
• Motor Neuron Disease
• Sclerosis
• Shortness of Breath

Intervention

Other:
• biological test
dyspnea evaluation, ventilatory evaluation and biological test before and after non invasive ventilation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the cytokines and endorphins rates variation after initiation of NIV in ALS patients	measure cytokines and endorphins blood levels before and after NIV	30 minutes