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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
cerebral fMRI
cerebral fMRI
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic obstructive pulmonary disease (COPD)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hôpital Bichat

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

PATIENT

Accepts Healthy Volunteers

Arm Description

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

Control arm with the same intervention

Outcomes

Primary Outcome Measures

Central ventilatory control
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
Evaluation of the neuronal activation bulbo-pontique and corticospinal during the application of an inspiratory resistance.
Chaotic analysis
The correlations will be performed between activated neuronal signals with fMRI and ventilatory flow output recordings (chaotic analysis).

Full Information

First Posted
April 4, 2011
Last Updated
August 13, 2013
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT01331070
Brief Title
Identification and Dynamics With Cerebral Functional Magnetic Resonance Imaging
Acronym
CHAOSBOLD
Official Title
Central Control of Breathing in Patients With Chronic Obstructive Pulmonary Disease: Identification and Dynamics With Cerebral Functional Magnetic Resonance Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic obstructive pulmonary disease (COPD)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PATIENT
Arm Type
Experimental
Arm Description
Patients, half with moderate (GOLD II) and half with severe (GOLD III) COPD
Arm Title
Accepts Healthy Volunteers
Arm Type
Other
Arm Description
Control arm with the same intervention
Intervention Type
Other
Intervention Name(s)
cerebral fMRI
Other Intervention Name(s)
the central breathing control with cerebral fMRI
Intervention Description
the central breathing control with cerebral fMRI in COPD patients
Intervention Type
Other
Intervention Name(s)
cerebral fMRI
Other Intervention Name(s)
the central breathing control with cerebral fMRI
Intervention Description
the central breathing control with cerebral fMRI in Accepts Healthy Volunteers
Primary Outcome Measure Information:
Title
Central ventilatory control
Description
Evaluation of the central ventilatory control at the patients COPD during the application of an inspiratory resistance.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Evaluation of the neuronal activation
Description
Evaluation of the neuronal activation bulbo-pontique and corticospinal during the application of an inspiratory resistance.
Time Frame
1 month
Title
Chaotic analysis
Description
The correlations will be performed between activated neuronal signals with fMRI and ventilatory flow output recordings (chaotic analysis).
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurence MANGIN, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Bichat
City
Paris
ZIP/Postal Code
75018
Country
France

12. IPD Sharing Statement

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Identification and Dynamics With Cerebral Functional Magnetic Resonance Imaging

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