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Neurobiological and Immunological Mechanisms of Dyspnea in ALS (BIOPNEA)

Sponsor
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04332198
Collaborator
(none)
30
Enrollment
1
Arm
15
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: biological test
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Neurobiological and Neuro-immunological Mechanisms of Dyspnea in Amyotrophic Lateral Sclerosis
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: ALS patients

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. the cytokines and endorphins rates variation after initiation of NIV in ALS patients [30 minutes]

      measure cytokines and endorphins blood levels before and after NIV

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
    ClinicalTrials.gov Identifier:
    NCT04332198
    Other Study ID Numbers:
    • 2019_A02882_55
    First Posted:
    Apr 2, 2020
    Last Update Posted:
    Mar 4, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Dyspnea
    Motor Neuron Disease
    Amyotrophic Lateral Sclerosis
    Sclerosis

    Study Results

    No Results Posted as of Mar 4, 2022