Identification and Dynamics With Cerebral Functional Magnetic Resonance Imaging

NCT ID: NCT01331070

Last Updated: 2013-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2013-03-31

Brief Summary

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.

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).

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic obstructive pulmonary disease (COPD)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

PATIENT

Patients, half with moderate (GOLD II) and half with severe (GOLD III) COPD

Group Type: EXPERIMENTAL

cerebral fMRI

Intervention Type: OTHER

the central breathing control with cerebral fMRI in COPD patients

Accepts Healthy Volunteers

Control arm with the same intervention

Group Type: OTHER

cerebral fMRI

Intervention Type: OTHER

the central breathing control with cerebral fMRI in Accepts Healthy Volunteers

Interventions

cerebral fMRI

the central breathing control with cerebral fMRI in COPD patients

Intervention Type: OTHER

cerebral fMRI

the central breathing control with cerebral fMRI in Accepts Healthy Volunteers

Intervention Type: OTHER

Other Intervention Names

the central breathing control with cerebral fMRI; the central breathing control with cerebral fMRI

Eligibility Criteria

Inclusion Criteria

• 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.

• 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurence MANGIN, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Bichat

Paris, , France

Countries

France

Other Identifiers

AOM10010

Identifier Type: OTHER

Identifier Source: secondary_id

P100136

Identifier Type: -

Identifier Source: org_study_id