Identification and Dynamics With Cerebral Functional Magnetic Resonance Imaging (CHAOSBOLD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01331070
First received: April 4, 2011
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

Chronic obstructive pulmonary disease (COPD) is a chronicle inflammatory disease with a non reversible diminution of the airway flow. COPD is caused most commonly from tobacco smoking, which triggers an abnormal inflammatory response in the lung. Worldwide, COPD ranked as the sixth leading cause of death in 1990. It is projected to be the fourth leading cause of death worldwide by 2030 due to an increase in smoking rates and demographic changes in many countries. COPD is responsible for 16000 deaths per year in France, 100 000 hospitalizations per year and the health care expenditure of COPD in France is 3.5 billion of Euros. Classical markers of the disease severity, the forced expiratory volume in one second, poorly correlates with dyspnea and prognosis. Therefore, many studies focused on the control of breathing in an attempt to understand the pathophysiological mechanisms involved in the progression of the disease. Breathing control is enhanced in patients with COPD due to the progressive failure of respiratory muscles (airflow obstruction, static and dynamic hyperinflation, positive intrinsic end expiratory pressure), the ventilation/ perfusion ratio abnormalities leading to the loss of the gaz exchange efficiency. Inspiratory command depends on the medulla automatic pathway and the voluntary corticospinal command. Indirect method of breathing control estimation suggested in COPD patients an increased excitability of neurons involved in the voluntary diaphragm activation and a reduced cortical reserve. This may represent an increase risk factor for acute respiratory failure. Until now, no study reported the central breathing control with cerebral fMRI in COPD patients.


Condition Intervention
Chronic Obstructive Pulmonary Disease
Other: cerebral fMRI

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Central Control of Breathing in Patients With Chronic Obstructive Pulmonary Disease: Identification and Dynamics With Cerebral Functional Magnetic Resonance Imaging

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Central ventilatory control [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Evaluation of the central ventilatory control at the patients COPD during the application of an inspiratory resistance.


Secondary Outcome Measures:
  • Evaluation of the neuronal activation [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Evaluation of the neuronal activation bulbo-pontique and corticospinal during the application of an inspiratory resistance.

  • Chaotic analysis [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    The correlations will be performed between activated neuronal signals with fMRI and ventilatory flow output recordings (chaotic analysis).


Enrollment: 40
Study Start Date: March 2011
Study Completion Date: March 2013
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PATIENT
Patients, half with moderate (GOLD II) and half with severe (GOLD III) COPD
Other: cerebral fMRI
the central breathing control with cerebral fMRI in COPD patients
Other Name: the central breathing control with cerebral fMRI
Accepts Healthy Volunteers
Control arm with the same intervention
Other: cerebral fMRI
the central breathing control with cerebral fMRI in Accepts Healthy Volunteers
Other Name: the central breathing control with cerebral fMRI

Detailed Description:

Chronic obstructive pulmonary disease (COPD) is a chronicle inflammatory disease with a non reversible diminution of the airway flow. COPD is caused most commonly from tobacco smoking, which triggers an abnormal inflammatory response in the lung. Worldwide, COPD ranked as the sixth leading cause of death in 1990. It is projected to be the fourth leading cause of death worldwide by 2030 due to an increase in smoking rates and demographic changes in many countries. COPD is responsible for 16000 deaths per year in France, 100 000 hospitalizations per year and the health care expenditure of COPD in France is 3.5 billion of Euros. Classical markers of the disease severity, the forced expiratory volume in one second, poorly correlates with dyspnea and prognosis. Therefore, many studies focused on the control of breathing in an attempt to understand the pathophysiological mechanisms involved in the progression of the disease. Breathing control is enhanced in patients with COPD due to the progressive failure of respiratory muscles (airflow obstruction, static and dynamic hyperinflation, positive intrinsic end expiratory pressure), the ventilation/ perfusion ratio abnormalities leading to the loss of the gaz exchange efficiency. Inspiratory command depends on the medulla automatic pathway and the voluntary corticospinal command. Indirect method of breathing control estimation suggested in COPD patients an increased excitability of neurons involved in the voluntary diaphragm activation and a reduced cortical reserve. This may represent an increase risk factor for acute respiratory failure. Until now, no study reported the central breathing control with cerebral fMRI in COPD patients. This pilot study also aims in estimating if the absence or diminution of the cortical reserve is a marker of disease severity. In addition correlations will be performed between activated neuronal signals with fMRI and ventilatory flow output recordings (chaotic analysis).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

INCLUSION CRITERIA for Patient:

  • Informed patients with written consent,
  • More than eighteen years old,
  • Patients having a social insurance
  • A previous medical examination
  • Patients, half with moderate (GOLD II) and half with severe (GOLD III) COPD will be included. These patients will be clinically in a steady state situation for at least one month (no acute exacerbation). GOLD grading of COPD patients will be performed according to the American Thoracic Society.

EXCLUSION CRITERIA for patient:

  • Long-term oxygen therapy
  • Previous cerebral vascular accident
  • Central neurological disease (tumor, Parkinson, etc.)
  • Nobody benefiting from a particular protection: pregnant woman, minor person, major person under guardianship and under guardianship, the persons hospitalized without their consent and protected by the law, or the private persons of freedom.
  • Contraindication in the functional intellectual MRI:
  • Port of a biomedical device like cardiac simulator
  • Cardiac defibrillator
  • Insulin pump or neurostimulating,
  • Claustrophobia,
  • Impossibility to remain lengthened
  • Presence of cerebral vascular clips, metallic foreign body intra-ocular, not compatible cardiac valve
  • Pregnancy

INCLUSION CRITERIA for Healthy Volunteers:

  • Informed healthy volunteer with written consent,
  • More than eighteen years old,
  • Healthy volunteer having a social insurance
  • A previous medical examination
  • Non-smoker
  • Non pathology and medicinal treatment

EXCLUSION CRITERIA for healthy volunteers:

  • Nobody benefiting from a particular protection: pregnant woman, minor person, major person under guardianship and under guardianship, the persons hospitalized without their consent and protected by the law, or the private persons of freedom.
  • Contraindication in the functional intellectual MRI:
  • Port of a biomedical device like cardiac simulator
  • Cardiac defibrillator
  • Insulin pump or neurostimulating,
  • Claustrophobia,
  • Impossibility to remain lengthened
  • Presence of cerebral vascular clips, metallic foreign body intra-ocular, not compatible cardiac valve
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01331070

Locations
France
Hôpital Bichat
Paris, France, 75018
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Laurence MANGIN, MD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01331070     History of Changes
Other Study ID Numbers: P100136, AOM10010
Study First Received: April 4, 2011
Last Updated: August 13, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Chronic obstructive pulmonary disease (COPD)

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014