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Longitudinal Study of the Default-mode Network Connectivity in Brain Injured Patients Recovering From Coma (ACI-Coma)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Institut National de la Santé Et de la Recherche Médicale, France
Sponsor:
Collaborators:
University Hospital, Toulouse
Association des Traumatisés du Crane et de la Face, Paris, France
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01620957
First received: April 11, 2012
Last updated: April 24, 2013
Last verified: April 2013
  Purpose

Several studies in healthy volunteers have suggested that the synchronized functional connectivity in the DMN (Deafult-Mode Network) would sustain the mental content at rest, and when required, a switch in the activity between the DMN and other networks involved in specific congnitive functions, would occur. This interaction permit to make the hypothesis, that baseline brain activity is likely to shape our ongoing " stream of consciousness " and could correlate with conscious perception. The investigators hypothesized that DMN connectivity strength would be related to the level of consciousness of brain-damaged patients. The investigators will follow severely brain-injured patient in coma. Clinical examination using standardized behavioural scales: FOUR score (Full Outline of UnResponsivess), Coma Recovery Scale-Revised); and brain imaging assessesments using MRI (functional and anatomical connectivity, cortical thickness) will be performed at: 3 to 30 (visit 1), and 60 (visit 2) days after insult. If patient recover a normal conscious state between 30 and 60 days, an additional clinical and brain imaging assessment will be performed to identify related changes in brain activity (visit 1*) Monitoring of vital parameters will be performed in patients by a senior anaesthesiologist throughout the experiment.


Condition
Coma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analyse de l'activité cérébrale intrinsèque Pendant le Coma et Lors du Retour à la Conscience

Resource links provided by NLM:


Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • Change of DMN resting state fMRI connectivity between 1 and 2 month after severe brain injury [ Time Frame: VISIT1 = coma state (an expected average of 3 to 30 days after brain injury), VISIT2 = recovery phase (an expected average of 30 to 60 days). Finally, in case of full recovery during the recovery phase an additional assessment will be performed (VISIT1*) ] [ Designated as safety issue: No ]
    To date, the functional significance of DMN resting state connectivity patterns remain unclear. We hypothesized that DMN connectivity strength would be related to the level of consciousness of non-communicative brain-damaged patients, as assessed by standardized behavioural scales (FOUR score, CRS-R). Furthermore, we expected that a disruption of functional connectivity in the DMN could predict brain-damaged patient's recovery.


Secondary Outcome Measures:
  • Compare functional and structural DMN connectivity between 1 and 2 month after severe brain injury [ Time Frame: VISIT1 = coma state (an expected average of 3 to 30 days after brain injury), VISIT2 = recovery phase (an expected average of 30 to 60 days). Finally, in case of full recovery during the recovery phase an additional assessment will be performed (VISIT1*) ] [ Designated as safety issue: No ]
    Functional DMN connectivity will be investigated using probabilistic independent component analysis. Structural connectivity counterpart, will be assessed by diffusor tensor imaging and cortical thickness.


Estimated Enrollment: 153
Study Start Date: July 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Coma patients

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

We will analyse DMN functional and anatomical connectivity in severely brain-injured patients in coma and during the first two month following brain injury. All patients will be admitted from one of the four Critical Care Units of University Teaching Hospital of Toulouse, France.

Criteria

Inclusion Criteria:

  • Brain-damaged patients in coma (trauma or anoxic origin).
  • Male and female, ranging in age from 18 to 75 years.

Exclusion Criteria:

  • Withdrawal of consent from the patients (or the persons having legal responsibility for them).
  • Sedation or general anaesthesia during assessement period (< 24 hours).
  • MRI contraindications
  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: NCT01620957

Contacts
Contact: Stein Silva, MD, PhD +33(0)672005706 stein.silva.s@gmail.com
Contact: Kader Boulanouar, PhD +33(0)562746176 kader.boulanouar@inserm.fr

Locations
France
Institut National de la Santé et de la Recherche Medicale, U825 Recruiting
Toulouse, Haute Garonne, France, 31059
Sub-Investigator: Isabelle Loubinoux, PhD         
Sub-Investigator: Patrice Peran, PhD         
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
University Hospital, Toulouse
Association des Traumatisés du Crane et de la Face, Paris, France
Investigators
Principal Investigator: Stein Silva, MD, PhD Inserm, Department of Anesthesiology and Critical Care at the University Teaching Hospital of Toulouse, France
Study Chair: Kader Boulanouar, PhD Institut National de la Santé Et de la Recherche Médicale, France
  More Information

No publications provided

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01620957     History of Changes
Other Study ID Numbers: C11-55 Inserm, 2012-A00009-34
Study First Received: April 11, 2012
Last Updated: April 24, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Default-mode network
Difussion tensor imaging
Cortical thickness
Coma
Vegetative state
Minimally conscious state
Neural correlate of consciousness

Additional relevant MeSH terms:
Coma
Consciousness Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Unconsciousness

ClinicalTrials.gov processed this record on November 24, 2014