Identification and Dynamics With Cerebral Functional Magnetic Resonance Imaging

NCT01331070 | Completed

• 2 other identifiers: P100136AOM10010
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic obstructive pulmonary disease (COPD)

Outcome Measures

Primary Outcomes (1)

• Central ventilatory control

  Evaluation of the central ventilatory control at the patients COPD during the application of an inspiratory resistance.

  1 month

Secondary Outcomes (2)

• Evaluation of the neuronal activation

  1 month

• Chaotic analysis

  1 month

Study Arms (2)

PATIENT

EXPERIMENTAL

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

Other: cerebral fMRI

Accepts Healthy Volunteers

OTHER

Control arm with the same intervention

Other: cerebral fMRI

Interventions

cerebral fMRI OTHER

the central breathing control with cerebral fMRI in COPD patients

Also known as: the central breathing control with cerebral fMRI

PATIENT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Informed healthy volunteer with written consent,
• More than eighteen years old,
• Healthy volunteer having a social insurance

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Bichat

Paris, 75018, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Laurence MANGIN, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2011
• First Posted: April 7, 2011
• Study Start: March 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2013
• Last Updated: August 14, 2013

Record last verified: 2013-08

Locations

FR (1)