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Correlation Between the Analysis of the Rapid Cortical Oscillations, the General Movements of the Preterm's and the Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT00726206
Recruitment Status : Completed
First Posted : July 31, 2008
Last Update Posted : August 28, 2014
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief Summary:
The general movement and the electroencephalogram analysis of the preterm have a high predictive value of the neuro-developmental outcome of the infants.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Other: Electroencephalogram, recording the movements Not Applicable

Detailed Description:
Compare the technical and the predictive characteristics of the qualitative analysis of the spontaneous motility with those of actual exams of reference diagnosis : magnetic resonance imaging, electroencephalogram and transfontanellar imaging.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Correlation Between the Analysis of the Rapid Cortical Oscillations, the General Movements of the Preterm's and the Cerebral Palsy
Study Start Date : July 2008
Actual Primary Completion Date : August 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
1
Recording of the movements Recording of the electroencephalogram
Other: Electroencephalogram, recording the movements
Electroencephalogram, recording the movements of the child, RMI, Transfontanel Imaging



Primary Outcome Measures :
  1. To prove the predictive value of the " Deltas Brushes " triggered by hand or foot stimulation in correlation with the general movement analysis in the cerebral palsy diagnosis. [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. To prove that the general movement of the preterm increases the predictive value the actual monitoring of the preterm's in the diagnosis of cerebral palsy. [ Time Frame: 36 months ]


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Ages Eligible for Study:   up to 23 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children been born between 15/01/08 and 15/01/10
  • children whose term is lower than 28 weeks of amenorrhoea

Exclusion Criteria:

  • Born child superior to 28 weeks of amenorrhoea
  • presenting child a genic syndrome, an evolutionary neurological disease, a pathology malformative

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00726206


Locations
France
Service de Médecine Infantile et Néonatologie, CHU Nord
Marseille, France, 13915
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: Catherine GIRE, MD Assistance Publique des Hopitaux de Marseille

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT00726206     History of Changes
Other Study ID Numbers: 2008-A00062 53
2008-02
First Posted: July 31, 2008    Key Record Dates
Last Update Posted: August 28, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases